Journal articles on the topic 'Blood products Quality control'
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Conte, R., and V. Giudice. "Quality Control of Cytapheresis Products." International Journal of Artificial Organs 21, no. 6_suppl (May 1998): 39–41. http://dx.doi.org/10.1177/039139889802106s09.
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The Italian government has recently adopted the Council of Europe Recommendation no.R (95)15 on GMP (Good Manufacturing Practice) and quality control of blood components. However, there is still discussion as to which assays are appropriate for the quality control of plateletpheresis concentrate, PBSC concentrate and granulocyte concentrate. The main issues of programs to ensure the delivery of high quality products are discussed.
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Patel, Swapnil N., Mustafa Ranapurwala, and Menka Shah. "QUALITY CONTROL OF BLOOD COMPONENTS-A STEP TOWARDS EFFICIENT SUPPLY OF BLOOD PRODUCTS." International Journal of Advanced Research 4, no. 4 (April 30, 2016): 570–72. http://dx.doi.org/10.21474/ijar01/164.
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Finch, S. J., J. B. Chen, C. H. Chen, M. M. Hall, V. Matkovich, B. Wenz, H. Brandwein, and J. Whitbread. "Process control procedures to augment quality control of leukocyte-reduced red cell blood products." Statistics in Medicine 18, no. 10 (May 30, 1999): 1279–89. http://dx.doi.org/10.1002/(sici)1097-0258(19990530)18:10<1279::aid-sim112>3.0.co;2-6.
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ISHII, YOSHIKAZU, SACHI BABA, and MASATAKA ICHIKAWA. "Quality Control of Blood Derivatives: Properties of Concentrated Products of Human Antithrombin. III." Japanese Journal of Hospital Pharmacy 18, no. 3 (1992): 299–303. http://dx.doi.org/10.5649/jjphcs1975.18.299.
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ISHII, YOSHIKAZU, YUKIE YASUMURA, JUNICHI KAWAMURA, MASATAKA ICHIKAWA, MITSUO KAKU, TOSHIAKI USUI, YASUHISA INOUE, and KUNIO TAKANO. "The Quality Control of Blood Derivatives: Qualitative Tests of Factor VIII Concentrate Products." Japanese Journal of Hospital Pharmacy 18, no. 4 (1992): 378–84. http://dx.doi.org/10.5649/jjphcs1975.18.378.
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Sultan, Sadia, Hasan Abbas Zaheer, Usman Waheed, Mohammad Amjad Baig, Asma Rehan, and Syed Mohammed Irfan. "Internal quality control of blood products: An experience from a tertiary care hospital blood bank from Southern Pakistan." Journal of Laboratory Physicians 10, no. 01 (January 2018): 064–67. http://dx.doi.org/10.4103/jlp.jlp_97_17.
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Abstract INTRODUCTION: Internal quality control (IQC) is the backbone of quality assurance program. In blood banking, the quality control of blood products ensures the timely availability of a blood component of high quality with maximum efficacy and minimal risk to potential recipients. The main objective of this study is to analyze the IQC of blood products as an indicator of our blood bank performance. METHODS: An observational cross-sectional study was conducted at the blood bank of Liaquat National Hospital and Medical College, from January 2014 to December 2015. A total of 100 units of each blood components were arbitrarily chosen during the study. Packed red cell units were evaluated for hematocrit (HCT); random platelet concentrates were evaluated for pH, yield, and culture; fresh frozen plasma (FFP) and cryoprecipitate (CP) were evaluated for unit volume, factor VIII, and fibrinogen concentrations. RESULTS: A total of 400 units were tested for IQC. The mean HCT of packed red cells was 69.5 ± 7.24, and in 98% units, it met the standard (<80% of HCT). The mean platelet yield was 8.8 ± 3.40 × 109/L and pH was ≥6.2 in 98% bags; cultures were negative in 97% of units tested. Mean factor VIII and fibrinogen levels were found to be 84.24 ± 15.01 and 247.17 ± 49.69 for FFP, respectively. For CP, mean factor VIII and fibrinogen level were found to be 178.75 ± 86.30 and 420.7 ± 75.32, respectively. CONCLUSION: The IQC of blood products at our blood bank is in overall compliance and met recommended international standards. Implementation of standard operating procedures, accomplishment of standard guidelines, proper documentation with regular audit, and staff competencies can improve the quality performance of the transfusion services.
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Khan, Maria, Junaid Tariq, Muhammad Ali Rathore, Asad Mahmood, Mansoor Ishaq Raja, and Saima Bashir. "Assessment of Internal Quality Control of Blood Products; Experience at a Regional Transfusion Centre from Northern Pakistan." Pakistan Armed Forces Medical Journal 72, no. 4 (September 7, 2022): 1439–43. http://dx.doi.org/10.51253/pafmj.v72i4.8642.
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Objective: To analyze internal quality control of blood components, including red cell concentrates, fresh frozen plasma, cryoprecipitate and random donor platelets, to measure our blood bank performance.
Study Design: Cross-sectional study.
Place and Duration of Study: Armed Forces Institute of Transfusion (AFIT), Rawalpindi Pakistan from Jul to Dec 2021.
Methodology: Whole blood units were separated into red cell concentrates, fresh frozen plasma and random platelets by the platelet-rich plasma method. Cryoprecipitates were prepared from FFPs. Quality control was done on representative components. For red cell concentrates, hematocrit was measured. For platelet concentrates, pH and platelet yield were measured. For fresh frozen plasma, Factor-VIII assay and for cryoprecipitate, Factor VIII and fibrinogen assays were done. The blood components were also tested for bacterial cultures.
Results: A total of 1130 units were analyzed for quality control, including 360 red cell concentrates, fresh frozen plasma, random donor platelets each and 50 cryoprecipitates. Red cell concentrates had a mean hematocrit of 68.5±3.7%. Random donor platelets had a yield of 10.1±1.4× 1010 / unit and a mean pH of 6.7±0.2. Fresh frozen plasma had a Factor VIII level of 2.2±0.98 IU/ml. Cryoprecipitate had a mean fibrinogen level of 202.8±27.8 mg/unit and Factor VIII132.5±54.1IU/unit. All blood components met internal quality control standards. Blood cultures were negative in 99.2% of random donor platelets tested.
Conclusion: The internal quality control of blood products was in concordance with the national and international standards for quality control in blood banks.
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Martin, Miguela, David Perez-Guaita, and Bayden R. Wood. "ATR-FTIR spectroscopy as a quality control system for monitoring the storage of blood products." Analytical Methods 13, no. 47 (2021): 5756–63. http://dx.doi.org/10.1039/d1ay01242h.
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Ali, Isam Eldin Hassan, Dr Abdelaziz M. Humd, Dr Manal Mostafa, and Hamza Abdallah. "Quality Control in Screening for Infectious Diseases at Blood Banks." Scholars Journal of Applied Medical Sciences 10, no. 2 (February 28, 2022): 261–62. http://dx.doi.org/10.36347/sjams.2022.v10i02.022.
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Background: It has long been recognized that blood bank institutions have an obligation to not only provide a safe product for patients, but also to protect the health and welfare of their donors and their staff. Quality control procedures are indispensable to en¬sure the reliability of the results provided by labora¬tories responsible for serological screening in blood banks. International recommendations on systems of quality management classify as a top component the inclusion of two types of control: (a) internal quality control (IQC) and (b) external quality control (EQC). Methods: A total of 300 donations were collected and screened for HBV, HCV, syphilis and HIV-1 using the enzyme inked immune sorbent assay. All initially reactive (IR) samples were retested in triplicate and, if repeatedly reactive (RR), consider as reactive. Results: The results showed that the sensitivity and specificity of the QCs in anti-B testing were 100% and 98.7%, respectively. The sensitivity and specificity of the QCs in testing, viral screening were all 99%. Therefore our QC products and methods are highly sensitive, specific, and reliable. Our study paves the way for the establishment of a uniform and standardized QC method for pre-transfusion compatibility testing in Sudan and other parts of the world. Conclusion: The implementation of screening for three viruses has improved blood safety in Sudan.
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Xu, Gui-Ping, Li-Fang Wu, Jing-Jing Li, Qi Gao, Zhi-Dong Liu, Qiong-Hua Kang, Yi-Jun Hou, et al. "Performance Assessment of Internal Quality Control (IQC) Products in Blood Transfusion Compatibility Testing in China." PLOS ONE 10, no. 10 (October 21, 2015): e0141145. http://dx.doi.org/10.1371/journal.pone.0141145.
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Ryder, K. W., S. J. Jay, M. R. Glick, and J. R. Woods. "Effect of storage temperature and shaking rate on pH and blood-gas results for two quality-control products." Clinical Chemistry 34, no. 9 (September 1, 1988): 1910–12. http://dx.doi.org/10.1093/clinchem/34.9.1910.
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Abstract Directions for pre-analytical handling of ampules of two commercially available aqueous quality-control products (contrlL and G.A.S.) contain vague instructions such as "store at room temperature" and "shake vigorously" before analysis. We examined the effect of different storage temperatures (25, 31, and 38 degrees C) and shaking rate (one, two, and four shakes per second) on pH and blood-gas results. For both products, increasing the storage temperature significantly decreased pO2 results, the magnitude of the bias being greatest for those solutions with the highest O2 tensions. However, increasing the shaking rate partly offset this bias. Increasing storage temperature also decreased results for pCO2 and increased results for pH for both manufacturers' ampules with the highest CO2 tensions, and this bias was not offset by increasing the shaking rate. We conclude that both storage temperature and shaking rate must be precisely defined and carefully monitored before these products are used in a quality-control program.
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Primasari, Renata, and Wahyu Wirahmayati. "The Effectiveness Of The Apheresis Method On The Quality Of Trombosit Concentrat At UTD PMI Surabaya." STRADA Jurnal Ilmiah Kesehatan 9, no. 2 (November 1, 2020): 1617–21. http://dx.doi.org/10.30994/sjik.v9i2.511.
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Apheresis is obtained from one donor, donors are connected to a machine that can clean up blood and only take platelets. The remaining cells and blood plasma are then returned to the donor's body. The purpose of this study was to determine the effectiveness of apheresis methods on the quality of blood products in UTD PMI Surabaya. This type of research uses a post test only control design, which was conducted on November 1st, 2019 - March 30th, 2020 with a sample of 50 TC Apheresis and 50 TC conventional. The quality of blood products carried out by the apheresis method at UTD PMI Surabaya has met the quality standards that have been tested. While the quality of blood products that do not use the Apheresis method at UTD PMI Surabaya, there are 2 samples that do not meet the standards, 48 other samples have met the standards
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Astutiningtiyas, Silvi, Luthfi Rusyadi, and Yeti Kartikasari. "QUALITY CONTROL OF PACKED RED CELL (PRC) PRODUCT IN BLOOD DONATION UNIT." Jurnal Riset Kesehatan 11, no. 1 (May 31, 2022): 21–27. http://dx.doi.org/10.31983/jrk.v11i1.8506.
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Blood Transfusion Service Standards aim to ensure the safety high quality and sufficient blood services sufficient blood reserve. The standard for blood requirements for each country according to WHO is at least 2% of the total population. The population in Indonesia has increased every year so the need for blood is also increasing causing demands for causing the quality of blood services to be better. One of the demands for the quality of blood services by knowing is to know the quality control of the blood produced. One of the blood products produced is PRC. PRC Packed Red Cells quality control checks must be carried out to determine the quality of the PRCs produced. This study aims to determine the overall quality control of PRC and the results of PRC quality control based on (volume, hemoglobin, hematocrit, hemolysis, and bacterial contamination) in the Blood Donation Unit of Banyumas Regency in 2020. This type of research is descriptive. Sampling technique with a sample quota as much as the total sample quality control packed red cell test obtained 1% of the total production of PRC components every month in the Blood Donation Unit of Banyumas. The QC research results were obtained from 430 PRC samples that met the passing standards: 426 samples (99%) volume, 426 samples (99%) hemoglobin, 380 samples (88%) hematocrit, 429 samples (99.7%) hemolysis, and 426 samples (99%) passed from bacterial contamination. The number of QCs who qualified was 373 samples (87%). These results indicate that the 2020 PRC QC obtained good and satisfying results.
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Javaudin, Olivier, A. Baillon, N. Varin, C. Martinaud, T. Pouget, C. Civadier, B. Clavier, and A. Sailliol. "Air-drop blood supply in the French Army." Journal of the Royal Army Medical Corps 164, no. 4 (February 12, 2018): 240–44. http://dx.doi.org/10.1136/jramc-2017-000886.
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BackgroundHaemorrhagic shock remains the leading cause of preventable death in overseas and austere settings. Transfusion of blood components is critical in the management of this kind of injury. For French naval and ground military units, this supply often takes too long considering the short shelf-life of red blood cell concentrates (RBCs) and the limited duration of transport in cooling containers (five to six days). Air-drop supply could be an alternative to overcome these difficulties on the condition that air-drop does not cause damage to blood units.MethodsAfter a period of study and technical development of packaging, four air-drops at medium and high altitudes were performed with an aircraft of the French Air Force. After this, one air-drop was carried out at medium altitude with 10 RBCs and 10 French lyophilised plasma (FLYP). A second air-drop was performed with a soldier carrying one FLYP unit at 12 000 feet. For these air-drops real blood products were used, and quality control testing and temperature monitoring were performed.ResultsThe temperatures inside the containers were within the normal ranges. Visual inspection indicated that transfusion packaging and dumped products did not undergo deterioration. The quality control data on RBCs and FLYP, including haemostasis, suggested no difference before and after air-drop.DiscussionThe operational implementation of the air-drop of blood products seems to be one of the solutions for the supply of blood products in military austere settings or far forward on battlefield, allowing safe and early transfusion.
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Ramos, Thomas, William Busby, Gaytha McPherson, and Scott Burger. "Human blood-derived raw material: enabling controlled, consistent collection (P4415)." Journal of Immunology 190, no. 1_Supplement (May 1, 2013): 205.17. http://dx.doi.org/10.4049/jimmunol.190.supp.205.17.
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Abstract Human cells are critical raw materials for manufacturing cell therapy products, but often introduce significant variability. Rigorous operational controls and quality systems, however, enable optimal collection of high-quality, consistent cellular material. HemaCare, a long-standing supplier of human-derived blood components, controls apheresis procedures and collection sites under a formal quality system, with GMP-compliant, validated procedures and equipment, and GTP-compliant donor screening and tracking. HemaCare performed 69,658 cellular apheresis collections in the last five years, including patient and normal-donor MNCs, G-CSF-mobilized PBPCs and plateletpheresis products, for use in research, clinical trials, and commercial products. Expanded capabilities include bone marrow, umbilical cord blood, and cord tissue collection, immunomagnetic selection, cryopreservation, and analysis by flow cytometry. HemaCare unmobilized apheresis products showed consistently high MNC purity, with 93.8% of products containing ≥75% MNC, and an average of 85.2% MNC ± 6.6% (mean ± 1 SD). Red blood cell contamination was low, with hematocrit averaging 1.8% ± 0.8%. Approximately 85% of HemaCare donors have donated apheresis products 5 or more times, and this repeat-donor pool also contributes to product consistency, as MNC content of individual donor apheresis products had an average coefficient of variation of 3.5%, compared to a CV of 7.7% for all apheresis products.
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Cheah, Poh Lin, Chong Wei Ong, and Philip Crispin. "Microbial contamination of autologous peripheral blood stem cell products: incidence, clinical outcome, quality control and management strategies." Pathology 43, no. 4 (June 2011): 340–45. http://dx.doi.org/10.1097/pat.0b013e32834642ec.
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YU, YANG, CHUNYA MA, QIAN FENG, XIN CHEN, XIAOZHEN GUAN, XIAOJUAN ZHANG, LINFENG CHEN, et al. "Establishment and performance assessment of preparation technology of internal quality control products for blood transfusion compatibility testing." Experimental and Therapeutic Medicine 5, no. 5 (March 7, 2013): 1466–70. http://dx.doi.org/10.3892/etm.2013.994.
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Fast, Loren D., Susanne Marschner, Gilbert DiLeone, Suzann Doane, Christy Fitzpatrick, and Goodrich Ray. "Inactivation of Human White Blood Cells in Red Blood Cell Products Using the MIRASOL® System for Whole Blood." Blood 110, no. 11 (November 16, 2007): 2897. http://dx.doi.org/10.1182/blood.v110.11.2897.2897.
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Abstract Transfusion of blood products containing white blood cells (WBC) can result in the induction of immune responses that can negatively impact the recipient. An approach that would mitigate these consequences would be beneficial. Previous studies had shown that exposure of platelet concentrates to light in the presence of riboflavin was able to inhibit immune responses mediated by WBC. To make this protocol more widely applicable the effect of treating whole blood units with riboflavin and varying amounts of light was tested. Human peripheral blood mononuclear cells were purified by Ficoll-Hypaque discontinuous centrifugation from aliquots of nonleukoreduced whole blood units that were untreated or exposed to Mirasol treatment using varying light dosages. Viability and phenotype of treated cells was unchanged compared to untreated controls. The results showed that exposure of whole blood units to 33J/mL red blood cells (RBC) UV light in the presence of riboflavin completely inhibited proliferation of WBC in response to polyclonal stimulators such as phytohemagglutinin, and anti-CD3/CD28 or to allogeneic stimulator cells in a mixed lymphocyte culture (MLC). Additional assays showed that treated WBC were unable to induce proliferation of normal responder cells in an MLC. Treated cells did not produce inflammatory or TH1/TH2 cytokines when stimulated with lipopolysaccharide for 24 hours or anti-CD3/CD28 for 72 hours. In addition, treatment was found to inhibit T cell activation as evidenced by the lack of CD69 expression in treated compared to untreated control cells when incubated with phorbol 12-myristate 13-acetate. These treatment conditions did not induce crossmatch incompatibility. Methemoglobin levels and hemolysis in RBC units stayed below 1% during storage for 42 days in AS-3. Platelet and plasma units separated from whole blood after treatment showed acceptable cell and protein quality over 5 days in storage or as fresh frozen plasma, respectively. In summary, Mirasol treatment was able to functionally inactivate WBC in whole blood products without adversely affecting the quality of the RBC, platelets and plasma. This technique offers potential means to achieve inactivation of WBC in whole blood units that can subsequently be separated into RBC, platelet and plasma components.
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Alving, Barbara, and Kirsten Alcorn. "How to Improve Transfusion Medicine: A Treating Physician's Perspective." Archives of Pathology & Laboratory Medicine 123, no. 6 (June 1, 1999): 492–95. http://dx.doi.org/10.5858/1999-123-0492-htitm.
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Abstract As transfusion medicine becomes more complex, cooperative strategies are gaining increasing importance in relaying information to the treating physician and in incorporating the treating physician into the education and quality control processes. The broad domain of transfusion medicine is illustrated by the variety of disciplines involved in defining the use of products such as fresh frozen plasma and the newly released solvent-detergent–treated plasma, fibrin glue and highly purified fibrin sealant, and leukoreduced and irradiated blood products. Cooperative efforts among physicians and other personnel of multiple disciplines are essential to ensure appropriate use and continuous evaluation of blood products.
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Vodyakova, M. A., A. R. Sayfutdinova, E. V. Melnikova, and Yu V. Olefir. "Comparison of the World Pharmacopoeias’ Requirements for the Quality of Cell Lines." BIOpreparations. Prevention, Diagnosis, Treatment 20, no. 3 (September 18, 2020): 159–73. http://dx.doi.org/10.30895/2221-996x-2020-20-3-159-173.
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The cell line is one of the necessary components of a biomedical cell product (BMCP) which can include only viable human cells. In addition, human, animal, insect, or bacterial cell lines can be used as a substrate for the production of some biological drugs. The list of quality parameters and test methods for medicinal products quality control are specified in the State Pharmacopoeia of the Russian Federation, but it contains only a few general monographs on blood products and a few requirements for cell lines as substrates for the production of biological drugs (which cover all types of cells). Currently, there is no regulatory document comparable to the State Pharmacopoeia of the Russian Federation that would contain requirements and test methods for BMCP quality control in the Russian Federation. Thus, one of the issues that arises both during quality control and approval of BMCPs is the lack of a regulatory document defining requirements for BMCP quality parameters and test methods. However, some general monographs of the Russian Pharmacopoeia and other pharmacopoeias can be used for quality control of both cell lines and non-cellular components. The aim of the study was to analyse and compare different pharmacopoeial requirements for the quality of cell lines used as components in human cell- and tissue-based products (comparable to BMCPs), which could be used in BMCP quality control. The paper analyses general monographs of the United States Pharmacopoeia (USP), European Pharmacopoeia (Ph. Eur.), Japanese Pharmacopoeia, Pharmacopoeia of the Republic of Belarus, including general monographs on biological/biotechnological products, because their requirements apply to human cell lines included as components in products similar to BMCPs. The analysed approaches and methods of quality control of cell- and tissue-based products described in the USP and Ph. Eur. could form the basis for elaboration of general monographs for the Russian Pharmacopoeia, including identification, potency, viral safety, and mycoplasma tests that are based on the nucleic acid amplification technology and other tests for cell lines as components of BMCPs.
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Fu, Tiantian, Liya Niu, Yun Li, Dongming Li, and Jianhui Xiao. "Effects of tea products on in vitro starch digestibility and eating quality of cooked rice using domestic cooking method." Food & Function 11, no. 11 (2020): 9881–91. http://dx.doi.org/10.1039/d0fo02499f.
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Stanojkovic, Zoran, Ana Antic, and Miodrag Stojanovic. "Effects of use of riboflavin and ultraviolet light for pathogen inactivation on quality of platelet concentrates." Vojnosanitetski pregled 68, no. 6 (2011): 489–94. http://dx.doi.org/10.2298/vsp1106489s.
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Background/Aim. Pathogen inactivation in blood and blood products is one of the major means to achieve a zero risk blood supply and improve transfusion safety. Riboflavin (vitamin B2) activated by ultraviolet (UV) light, produces active oxygen which damages cell membrane and prevents replication of the carrier of diseases (viruses, bacteria, protozoa) in all blood products. The aim of this study was to establish the influence of the process of pathogens photoinactivation using riboflavin and UV rays on the biochemical and functional characteristics of platelet concentrates prepared from ?buffy coat?. Methods. The examination included 80 platelet concentrates prepared from ?buffy coat?, which was separated from whole blood donated by voluntary blood donors around 6 hours from the moment of collection. Concentrates were pooled, filtered and separated unton two groups: one consisted of 10 control units and the other of 10 examined units (pooled platelet concentrates). Examined units of the platelets were treated by riboflavin (35 mL) and UV rays (6.24 J/mL, 265-370 nm) on Mirasol aparature (Caridian BCT Biotechnologies, USA) in approximate duration of 6 min. A total of 35 mL of saline solution was added to the control units. The samples for examining were taken from the control and examined units initially (K0, I0), after the addition of saline (K1) and riboflavin (I1), after illumination (I2), first day of storage (K3, I3) and the fifth day of storage (K4, I4). The following parameters were measured: platelet count and platelet yield, residual erythrocyte and leukocyte count, pH, pO2, pCO2 and bacterial contamination. Results. All the measured parameters showed a statistically significant decrease comparing to K0 and I0; all the results of the first day of platelet storage showed statistically significant decrease comparing to K1 and I1, and all the results of the fifth day of platelet storage (K4, I4) showed a statistically significant decrease comparing to K1 and K3 and to I1 and I3. There was no the mentioned difference in the measured parameters between K4 and I4 (the end of storage - the fifth day). All the platelet units were sterile till the seventh day, when the investigation ended. Conclusion. Platelet concentrates inactivated by riboflavin and UV rays (Mirasol PRT sistem, Caridian BCT, USA) keep all the characteristics assessed by the Guide to the preparation, use and quality assurance of blood components (Council of Europe), during the whole storage period (five days). The obtained data were correlated with existing up to date literature and demonstrated that Mirasol treated platelets were safe and could be incorporated effectively in the routine blood bank and transfusion setting.
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Habtemariam, Solomon. "Could We Really Use Aloe vera Food Supplements to Treat Diabetes? Quality Control Issues." Evidence-Based Complementary and Alternative Medicine 2017 (2017): 1–10. http://dx.doi.org/10.1155/2017/4856412.
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Diabetes UK has recently listed a number of herbs and spices that have been clinically shown to improve blood glucose control in type-2 diabetes patients and the diabetes high-risk group. With Aloe vera being top in this list, its health benefit along with health and beauty/food retailers supplying it was illustrated in detail. Previous article from this laboratory scrutinised the merit of using A. vera as an alternative therapy to prescription antidiabetic drugs and the risk of using food supplements in the market which do not qualify as drug preparations. In continuation of this discussion, the present study assesses three Aloe Pura brands and one Holland and Barret brand of A. vera juice supplements in the UK market through chromatographic and spectroscopic analysis. While the polysaccharide active ingredient, acemannan, appears to be within the recommended limit, it was found that Aloe Pura (one of the best-selling brands for A. vera supplement) products have benzoate additive that does not appear in the supplement levels. Moreover, two of the Aloe Pura brand juices contain methanol, suggesting that the International Aloe Science Council (IASC) certification does not guarantee the medicinal quality of these products. The therapeutic fitness of such supplements is discussed.
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Ngo, Ednajoy, Cheng Ean Chee, Melinda Khoo, Yee Mei Lee, Belinda Tan, Yen-Lin Chee, and Wei-Ying Jen. "Maximising Capacity and Saving Cost in an Outpatient Chemotherapy Centre during a Pandemic: A Quality Improvement Project." Blood 136, Supplement 1 (November 5, 2020): 25–26. http://dx.doi.org/10.1182/blood-2020-139138.
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Introduction Blood transfusion is an integral part of routine outpatient Haematology-Oncology care. Blood product administration requires the concerted effort of nursing and laboratory staff in accredited institutions. One of the challenges with scheduling transfusions is the unpredictability surrounding transfusion requirements and the amount of time required to administer blood products. This mismatch between capacity availability for ad hoc transfusions and clinical need has resulted in physicians pre-booking transfusion slots so patients can be transfused if needed. However, when patients do not require transfusions, their cancelled slots represent capacity which could have otherwise been used to administer chemotherapy. This problem is exacerbated in a pandemic, where demand for inpatient beds necessitates the transition of elective chemotherapy to the outpatient setting insofar as is possible. Aim We hypothesized that reducing the number of transfusion slots booked could help to save healthcare-related costs and improve capacity utilisation. We also sought to right-site blood transfusions away from the chemotherapy infusion unit and to an acute cancer care unit (ACCU). Methods On 1 May 2020, two simple workflow changes were made. First, we introduced a policy where transfusions could not be pre-booked. Physicians were reassured that their patients would be transfused before their patient's crossmatch sample expired and that urgent transfusions would be done on the same day. The only exceptions to this policy were regularly transfused patients (e.g. thalassaemia major patients on chronic transfusions) and infirm patients. Secondly, ad hoc blood transfusions were moved from the chemotherapy unit to the acute cancer care unit. Ad hoc transfusion timing was prioritised according to clinical need. Consecutive patients treated at the National University Cancer Institute, Singapore, from 1 July 2019 to 31 July 2020 were included. Scheduled appointments were extracted from the hospital's scheduling system and analysed. Patients who had appointments booked for blood product transfusions were included. Data was extracted from drug ordering systems to determine the number of blood products administered. Patients were divided into a historical control group (before 1 May) and a study group (after 1 May). The primary outcome measures were cancellation rate (defined as the number of cancellations over total number of slots booked for transfusion) and number of chair hours wasted. Secondary outcome measures included the number of patients who had to be admitted for blood transfusion due to lack of slot availability and cost savings reflected in unit chair hours made available. Categorical data were analysed by the chi-square test. Analysis was done with SPSS v22 (IBM, USA). Results Between 1 July 2019 and 31 July 2020, a total of 3144 slots were booked for transfusion. Each slot was booked for four hours. 1548 blood products were administered. In the control group, there were 1630 cancellations. This equated to 6520 hours of chemotherapy chair time (average of 652 hours/month). There were no nett cancellations in the study group, as total number transfused exceeded the number booked. Assuming the booking rate would have been similar without our intervention, the study resulted in 1956 unutilised chair hours saved. This reflects capacity created for administration of chemotherapy, and cost savings of 1956x, where x is the unit cost of one chair hour. The cancellation rate was 58.3% (1630 cancelled, 2800 booked) in the control group. This decreased to -9.9% in the study group (378 administered (i.e., no nett cancellations), 344 booked, p<0.001, Figure 1). No patients had to be admitted for elective blood transfusion after 1 May 2020. One patient had to be admitted emergently for blood transfusion because of concurrent cardiac failure. The primary reason for admission was intravenous diuresis. All ad hoc transfusions were administered in ACCU. Conclusion Efficient utilisation brought about by two simple workflow changes can help to create capacity and save costs. Such strategies are especially critical in a pandemic, where healthcare resources are under major strain and existing capacity must be maximised. Disclosures No relevant conflicts of interest to declare.
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Chejor, Pelden, Jigme Tenzin, and Jigme Dorji. "Regulation of Medicines in Bhutan: Current Status, Challenges and Opportunities." International Journal of Drug Regulatory Affairs 6, no. 2 (June 15, 2018): 54–58. http://dx.doi.org/10.22270/ijdra.v6i2.243.
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Medicines Regulatory Agencies (MRAs) are responsible for evaluation of quality, safety and efficacy of medicinal products before it is approved for consumption. The regulatory procedures, however, differs from one country to another. Medical products including vaccines, blood and blood products, diagnostics and medical devices are essential for healthcare delivery across the world. The Drug Regulatory Authority (DRA) is an independent national agency for regulation of medicinal products in Bhutan and reports to Bhutan Medicines Board (BMB), the highest policy making body for regulation of medicinal products in the country.
Medicines Act of the Kingdom of Bhutan is the legal tool for regulation of medicines in Bhutan. Medicinal products are regulated through premarketing and post-marketing control systems. All medicinal products available in the Bhutanese market are registered. DRA regulates all the medicinal products including vaccines, blood products and traditional medicines used for human and veterinary.
DRA is fully financed by the Government of Bhutan. Bhutan’s medicines regulatory system has evolved over the last one decade. However, as the regulatory mandate continues to increase, DRA is faced with several challenges in terms of human resource, infrastructure and testing laboratory among others. There are also opportunities for the DRA to improve its regulatory capacities to ensure availability of quality and safe medicines for the public.
Understanding the current practice of medicines regulation in Bhutan can help identify gaps and existing opportunities for improving the regulatory capacity. This article documents the existing practices, challenges and opportunities for regulation of medicinal products in Bhutan.
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Sukhanova, S. M., Z. E. Berdnikova, and A. S. Tikhonova. "Ways to Improve Quality Control of Culture Medium Used for Mycoplasma Detection." BIOpreparations. Prevention, Diagnosis, Treatment 19, no. 3 (September 17, 2019): 161–68. http://dx.doi.org/10.30895/2221-996x-2019-19-3-161-168.
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An urgent safety concern associated with biological products is contamination with mycoplasmas, which may originate from donor tissues and organs, virus harvests, culture medium components, trypsin, animal blood serum, as well as be transmitted by personnel involved in the manufacture of medicines. Currently, due to an increase in the range of biologicals available, there is a need for more sensitive and specific test methods. In the Russian practice, microbiological (culture-based) testing of finished pharmaceutical products for mycoplasma contamination is performed using complex culture media whose sensitivity depends on the quality of proteins, ingredients, and reagents used. Growth promotion properties of the media are determined according to the State Pharmacopoeia of the Russian Federation, 14th ed., using a single test strain — Mycoplasma arginini G230 (M. arginini G230 industry reference material). The aim of the study was to analyse current Russian and foreign requirements for the quality control of culture media that are used for mycoplasma detection, in order to update and improve the quality control procedure in Russia. It was demonstrated that a compelling advantage of the State Pharmacopoeia of the Russian Federation is the possibility of using a semi-liquid culture medium which does not require special aerobic or anaerobic incubation conditions and allows for quantification of mycoplasma colonies and determination of mycoplasma titre in culture medium while testing its growth promotion properties using reference М. arginini G230 test strain. The analysis revealed some differences in Russian and foreign requirements for quality evaluation of culture media. These differences were taken into account when developing recommendations for improvement of the Russian test procedure, i.e. enlarging the range of test strains used and development of respective reference standards.
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Hermansen, Kjeld. "Diet, blood pressure and hypertension." British Journal of Nutrition 83, S1 (June 2000): S113—S119. http://dx.doi.org/10.1017/s0007114500001045.
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Prevention of hypertension, and control of blood pressure in patients with hypertension, are necessary for the reduction of cardiovascular morbidity and mortality. Lifestyle modifications are one of the most important tools for effective lowering of blood pressure. Most randomized controlled studies have shown that even a modest weight loss of 3–9 % is associated with a significant reduction in systolic and diastolic blood pressure of roughly 3 mm Hg in overweight people. Limitation of sodium chloride in food has historically been considered the critical change for reducing blood pressure. Changes in sodium intake do affect blood pressure in older persons and in patients with hypertension and diabetes, whereas its role in population blood pressure has proven controversial. Recent meta-analyses indicate that adequate intake of minerals, e.g. potassium and probably calcium, rather than restriction of sodium, should be the focus of dietary recommendations. Although epidemiological data point to a direct relation between the intake of saturated fat, starch and alcohol, as well as an inverse relationship to the intake of omega-3 fatty acids and protein, our knowledge about macronutrients and blood pressure is scanty. It may well prove more productive to look at food instead of placing emphasis on single nutrients. Thus the Dietary Approaches to Stop Hypertension (DASH) demonstrates that a diet rich in fruits, vegetables, low-fat dairy products, fibre and minerals (calcium, potassium and magnesium) produces a potent antihypertensive effect. Such a diet is not very restrictive and should not produce compliance problems. Further high-quality research on the influence of macronutrients and food will yield data for updated recommendations, enabling better prevention and control of the blood pressure problem.
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Pandit, AP, Neha Bhagatkar, and Mallika Ramachandran. "Personal Protective Equipment used for Infection Control in Dental Practices." International Journal of Research Foundation of Hospital and Healthcare Administration 3, no. 1 (2015): 10–12. http://dx.doi.org/10.5005/jp-journals-10035-1030.
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ABSTRACT The potential size of India's dental market is vast and is expected to become one of the largest single country markets for overseas dental products and materials. The total market for the dental equipment and materials is estimated to be around US$ 90 million annually. There are more than 1, 80,000 dental professionals in India, 297 dental institutes and over 5,000 dental laboratories. Thus, there is a huge potential for the market of personal protective equipment (PPE) used for infection control in dentistry. India's market for dental products is extremely dynamic, with a current estimated growth rate of between 25 and 30%. Overall, the dental market is expected to grow by 20%.1 The personal protective equipment used in the practice of dentistry in India. Since dentistry is predominantly a surgical discipline, it leads to exposure to the pathogenic microorganisms harbored in blood, body fluids and other potentially infectious material. Thus, the use of adequate and good quality PPE is imperative for infection control in dental practice. With the growing potential of India's dental market, the growth of the market for PPE is inevitable. But, it is equally important to raise the awareness among dental community about good quality products adhering to required standards to prevent the usage of low-cost, uncertified and sub-standard products that decrease the safety levels of personnel. The present study is conducted with a view to observe the personal protective equipment used for infection control in dental practices. How to cite this article Pandit AP, Bhagatkar N, Ramachandran M. Personal Protective Equipment used for Infection Control in Dental Practices. Int J Res Foundation Hosp Healthc Adm 2015;3(1):10-12.
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Azmi, Muhammad Firdaus, Amilia Aminuddin, Jamia Azdina Jamal, Adila A Hamid, and Azizah Ugusman. "Quantified Piper sarmentosum Roxb. Leaves Aqueous Leaf Extract and Its Antihypertensive Effect in Dexamethasone-Induced Hypertensive Rats." Sains Malaysiana 50, no. 1 (January 31, 2021): 171–79. http://dx.doi.org/10.17576/jsm-2021-5001-17.
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The quality control of raw herbal materials is important to ensure the safety, efficacy, and reproducibility of herbal products. Herbal products with consistent efficacy should be standardized and quantified based on their bioactive phytochemical compounds. Piper sarmentosum Roxb. has been reported for its antihypertensive activity. However, its antihypertensive effect on dexamethasone-induced hypertension still lacks information. In this study, the quality of two batches of raw P. sarmentosum leaf materials was assessed for heavy metal and microbial contents, and their aqueous extracts were assayed for antioxidant activity. The aqueous extract of the second batch of P. sarmentosum leaves was the only extract that passed the heavy metal and microbial limits and had the highest antioxidant activity (50.00 ± 2.88%); therefore, this extract was used for subsequent studies. The extract was quantified for two phytochemical markers, rutin (0.09 ± 0.002%) and vitexin (0.23 ± 0.007%), using a validated ultrahigh performance liquid chromatography method. The quantified extract (500 mg/kg/day orally) was able to lower the systolic blood pressure, diastolic blood pressure, and mean arterial pressure of dexamethasone-induced hypertensive rats comparable to the positive control drug, captopril. In summary, the quantified aqueous extract of P. sarmentosum based on rutin and vitexin lowers the blood pressure of dexamethasone-induced hypertensive rats, but its underlying mechanism warrants further investigation.
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Niglio, Fabrizio, Paola Comite, Andrea Cannas, Angela Pirri, and Giuseppe Tortora. "Preliminary Clinical Validation of a Drone-Based Delivery System in Urban Scenarios Using a Smart Capsule for Blood." Drones 6, no. 8 (August 5, 2022): 195. http://dx.doi.org/10.3390/drones6080195.
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In this paper, we report on the validation of an autonomous drone-based delivery system equipped with a smart capsule for the transportation of blood products in urban areas. The influence of some thermo-mechanical parameters, such as altitude, acceleration/deceleration, external temperature and humidity, on the specimens’ integrity were analyzed. The comparison of the results carried out by hemolytic tests, performed systematically on samples before and after each drone flight, clearly demonstrated that the integrity of blood is preserved and no adverse effects took place during the transport; these results can be addressed to the smart-capsule properties, which allows integrating real-time quality monitoring and control of the temperature experienced by blood products and mechanical vibrations. In addition, we demonstrated this transport system reduces the delivery time considerably. A risk analysis (i.e., HFMEA) was applied to all delivery processes to assess possible criticalities. To the best of our knowledge, this is the first time a drone-based delivery system of blood products in an urban area has been validated to be employed in a future clinical scenario.
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Bongo, Lauren, Ravi Bhatia, and Lawrence S. Lamb. "Standard Processing of Apheresis Products for HSCT Provides Significant Cost Savings over Automated Processing without Impact on Time or Product Quality." Blood 132, Supplement 1 (November 29, 2018): 5693. http://dx.doi.org/10.1182/blood-2018-99-119295.
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Abstract Introduction: Automated cell manufacturing is becoming increasingly common in advanced manufacturing protocols in order to provide more linearity and quality control. However, most of the manufacturing performed within full-service cell therapy laboratories consists of routine processing for HSCT. Automated systems are also employed for basic cell processing although the value of these systems is not routinely assessed. We compared our standard method for cell washing and concentration using the Terumo 2991® to manual centrifuge-based processing autologous apheresis products, testing the hypothesis that manual centrifuge-based processing would decrease cost and staff time for processing of apheresis HSCT products. Methods: A total of 10 products were compared (9 myeloma and 1NHL). Using the Terumo 2991®, the collection bag was rinsed x2 with a Plamalyte A®/Sodium Citrate prior to automated centrifugation and the centrifuge module was rinsed in a similar manner following concentration and expression of the cell product. For centrifuge-based manual processing, the product was transferred from the collection bag to a transfer bag, centrifuged, and excess plasma expressed. Each product was diluted to 10% within 5 x 108WBC/ml with autologous plasma. Samples were obtained for cell counting, viability, and CD34 enumeration by flow cytometry at the beginning and end of processing and following cryopreservation/thawing and 7d storage. Hands-on time was assessed by an observer and materials cost was based on standard pricing for UAB Hospital. Statistical determinations consisted of mean, SD, and student's t-test. Results: The WBC/kg dose recovery was not significantly different between automated processing (x̅=0.894±0659) and manual centrifuge-based processing (x̅=0.938±0.0696, p=0.163). The CD34+/kg dose recovery also did not show a significant difference between automated (x̅=0.875±0.0920) and centrifuge-based processing (x̅=0.937±0.0897, p=0.302). Post processing total viability, however, was significantly improved for the manual centrifuge-based processing (x̅=0.940±0.0260 vs. x̅=0.890±0.0390 p=0.031). Post thaw and wash CD34+ viability showed no difference between automated processing (x̅=0.8260, SD=0.0840) and manual centrifuge-based processing (x̅=0.810, SD=0.0260, p=0.592). Patients that were transplanted the manual centrifuge-based processed products engrafted between days 11 and 13. The institution engraftment benchmark is 15 days with an average of 11.3 days. Hands-on time for processing was also not significantly different between the two methods (x̅=27.89±7.897min for automated vs x̅=34.88±9.975min for standard, p=0.169). The combined cost for labor and supplies for automated Terumo® 2991 is $174.01 per product processed and $63.58 for manual centrifuge-based product processed. This produces a cost saving of $110.43 per product processed. Conclusions: Taken together, these findings show that manual centrifuge-based processing creates significant cost savings and improved product viability for the same hands-on processing time and with no significant total or CD34+ cell loss. With the current financial trends in healthcare, significant savings in standard care is important for the laboratory and hospital providing care. Disclosures Lamb: Incysus Therapeutics Inc.: Consultancy, Equity Ownership, Membership on an entity's Board of Directors or advisory committees, Research Funding.
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Taylor, Gary R. J., and Christine M. Williams. "Effects of probiotics and prebiotics on blood lipids." British Journal of Nutrition 80, S2 (October 1998): S225—S230. http://dx.doi.org/10.1017/s0007114500006073.
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Since the early work of Mann and Spoerry, probiotics in the form of fermented milk products have been reputed to have cholesterol-lowering properties in humans. However, studies conducted since the early 1970s have produced equivocal findings, with interpretation of the outcomes complicated by use of excessive quantities of product, inadequate sample sizes, failure to control nutrient intake and energy expenditure and variations in baseline blood lipids. More recent studies are of better quality, but fail to provide convincing evidence that ‘live’ fermented milk products have cholesterol-lowering efficacy in man. Future studies using probiotics should ensure adequate sample sizes sufficient to detect relatively small changes in blood cholesterol and should be conducted over longer periods of time. The recent introduction of the concept of prebiotics has directed attention towards the possibility that alterations in gut microflora induced by the fermentation of non-digestible components of the diet may also have the potential to influence systemic lipid metabolism. This possibility has been strengthened by the observation that in animals, dietary oligofructosaccharides cause suppression of hepatic triglyceride and VLDL synthesis, resulting in marked reductions in triglyceride, and to a lesser extent cholesterol, levels. Evidence for similar effects in humans is sparse and more studies are needed, particularly with respect to effects on postprandial triglyceride concentrations.
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Hendriksen, Coenraad, Klaus Cussler, and Marlies Halder. "ECVAM's Role in the Implementation of the Three Rs Concept in the Field of Biologicals." Alternatives to Laboratory Animals 30, no. 2_suppl (December 2002): 41–46. http://dx.doi.org/10.1177/026119290203002s06.
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Biologicals can be defined as products that are derived from living organisms or are produced by them. They include vaccines, hormones, monoclonal and polyclonal antibodies, blood products and rDNA products. The production of conventionally produced biologicals requires an extensive batch-related quality control, to ensure that these products are both safe and potent. As several of the control tests rely on animal models, it is inevitable that large numbers of animals are used. Many initiatives have been undertaken in the last few decades to reduce, refine and replace the use of animals in this area. ECVAM has been involved in many activities to support the development, validation and implementation of these Three Rs methods. The role that ECVAM has played in a number of validation studies is summarised. It is concluded that ECVAM should continue to support the activities that have been shown to be successful, preferably in collaboration with the regulatory authorities.
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De Jesus, Victor R., X. Kate Zhang, Joan Keutzer, Olaf A. Bodamer, Adolf Mühl, Joseph J. Orsini, Michele Caggana, Robert F. Vogt, and W. Harry Hannon. "Development and Evaluation of Quality Control Dried Blood Spot Materials in Newborn Screening for Lysosomal Storage Disorders." Clinical Chemistry 55, no. 1 (January 1, 2009): 158–64. http://dx.doi.org/10.1373/clinchem.2008.111864.
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Abstract Background: Lysosomal storage disorders (LSDs) comprise more than 40 genetic diseases that result in the accumulation of products that would normally be degraded by lysosomal enzymes. A tandem mass spectrometry (MS/MS)-based method is available for newborn screening for 5 LSDs, and many laboratories are initiating pilot studies to evaluate the incorporation of this method into their screening panels. We developed and evaluated dried blood spot (DBS) QC materials for LSDs and used the MS/MS method to investigate their suitability for LSD QC monitoring. Methods: We incubated 3.2-mm punches from DBS controls for 20–24 h with assay cocktails containing substrate and internal standard. Using MS/MS, we quantified the resulting product and internal standard. Samples were run in triplicate for 3 consecutive days, and results were reported as product-to-internal standard ratios and enzyme activity units (μmol/L/h). Results: Enzyme activity interday imprecision (CV) for the high, medium, and low series were 3.4%–14.3% for galactocerebroside α-galactosidase, 6.8%–24.6% for acid α-galactosidase A, 7.36%–22.1% for acid sphingomyelinase, 6.2%–26.2% for acid α-glucocerebrosidase, and 7.0%–24.8% for lysosomal acid α-glucosidase (n = 9). In addition, DBS stored at −20° and 4 °C showed minimal enzyme activity loss over a 187-d period. DBS stored at 37° and 45 °C had lower activity values over the 187-day evaluation time. Conclusions: Suitable QC materials for newborn screening of LSDs were developed for laboratories performing DBS LSD screening. Good material linearity was observed, with goodness-of-fit values of 0.953 and higher. The QC materials may be used by screening laboratories that perform LSD analysis by MS and/or more conventional fluorescence-based screening methods.
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Antić, Ana, Sanja Živković-Đorđević, Suzana Stevanović, and Marija Jelić. "Processing and storage of blood components as a precondition for safe transfusion." Medicinska rec 1, no. 2 (2020): 10–14. http://dx.doi.org/10.5937/medrec2001010a.
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The preparation of blood components from whole blood collections must be standardized and compliant with recommendations, EU Directives and Standard Operative Procedures (SOPs). In order to achieve safe and efficient transfusion it is important to have automated separation of whole blood unit producing standardized blood components, good quality control and increased work efficiency. It is also very important that all blood components should be ISBT 128 labelled and properly storaged under the regulated conditions. One of the most important factors that increases transfusion safety is leucoreduction of blood components, which prevents several adverse effects following blood transfusion, as well replacement of plasma as a storage medium in red blood cells and platelet concentrates with preservative solutions, which results in the reduction of isoand HLA-antibodies and plasma proteins. Pathogen inactivation in blood products is the trend of modern blood transfusion practice and acts in the removal or inactivation of all pathogens that can be blood transmitted. It does not replace testing of blood units for transfusion-transmitted diseases, but it reduces the risk of "window phenomenon" and errors in testing, acting on the agents that are not included in routine testing. In circumstances where the pathogen reduction has not been introduced in practice routine bacteriological testing of blood components significantly decreases the occurrence of adverse reactions on contaminated blood. Processing using the most appropriate and effective methodologies and best laboratory practices, efficient inventory management system for optimum blood stocks, and effective blood cold chain for safe storage and distribution of blood and blood products are key requirements to ensure the safety of blood products.
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Akel, Salem, Christianna Henderson, Donna Regan, Deepika Bhatla, and William S. Ferguson. "Quality and Safety of Hematopoietic Progenitor Cell (HPC) Products Cryopreserved by Simple Passive Gradual Freezing Method." Blood 120, no. 21 (November 16, 2012): 4410. http://dx.doi.org/10.1182/blood.v120.21.4410.4410.
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Abstract Abstract 4410 To provide quality HPC products for transplantation, harvests of bone marrow (BM), Peripheral Blood Stem Cells (PBSCs) and Cord Blood (CB) are routinely cryopreserved by gradual cooling from ambient temperature to −90°C using Controlled Rate Freezing (CRF) systems before placement in liquid/vapor nitrogen storage. CRF systems generally utilize a freezing chamber and computer-controlled freezing cycle with an established sequence of steps where timing, target temperatures and cooling rates are defined. System failures that endanger product quality may occur due to impurities in liquid nitrogen, mechanical/software problems and probe malfunction. A more convenient and economical freezing may be performed by simple “passive freezing” (PF) where products are placed directly into an ultra-low freezer (−80°C). Continuous temperature monitoring during the freeze process is achieved using individual data loggers. In the PF process, products remain undisturbed during the freeze process, and are removed for placement in liquid/vapor nitrogen storage when the target product temperature is reached (−80°C). Probe specific freezing curves are generated from downloaded data logger information. In an internal validation study, the St. Louis Cord Blood Bank (SLCBB) investigated quality and safety of HPC products cryopreserved using this PF method. Evaluation was based on the analysis of freezing kinetics, post-thaw cell recoveries, and available transplant outcome data in reference to those obtained by the conventional CRF method. A total of twelve (12) red blood cell and plasma reduced CB products cryopreserved in 10% DMSO/Dextran by PF were thawed according to a validated albumin/dextran reconstitution thaw method. Compared to the programmed CRF system, PF product cooling rate to a temperature of −60°C was faster (1.2– 2.0°C/min compared to 1°C/min), ultimately followed by slower cooling rate to a product target temperature of −80°C (approximately 0.4°C/min compared to 10°C/min). The kinetics of PF curves resulted in longer freezing cycles with an average freeze time of 180 minutes compared to 80 minutes by CRF method. Post-thaw cell recoveries of the PF data set were comparable to those obtained from an established thaw control group of RBC and plasma reduced CB cryopreserved by CRF system (n = 25). Average percent recoveries for CB products cryopreserved by PF methodology compared to CRF system were reported as follows, respectively: viable nucleated cells (NC) by trypan blue = 84% +/− 5% compared to 71% +/− 6%, viable (7AAD) CD34+ cells = 67% +/− 7% compared to 63% +/− 15%, and colony forming unit (CFU) = 73% +/− 7% compared to 72% +/− 14%. Subsequently, the SLCBB reviewed post-thaw cell recoveries of ten (10) PBSC harvests cryopreserved by PF and thawed at the SLCBB for clinical transplantation. Similar to the CB evaluation, results indicated a high quality HPC product post-thaw with average percent recoveries reported as follows: viable nucleated cells (NC) by trypan blue = 79% +/− 10%, viable (7AAD) CD34+ cells = 81.2% +/− 20.2, and CFU = 73.6% +/− 21.9%. All PBSC products were thawed and infused with no reports of infusion-related adverse events. These PBSC products engrafted shortly within predicted time; absolute neutrophil count (ANC) > 500/uL was reported within 12 days, while platelets > 20,000/uL was achieved within 22 days. Retrospective review of more than 1,800 CB products distributed by the SLCBB for transplant showed that five (5) PF products were transplanted as singlet products to treat patients with myeloid malignancies. Transplant outcome data received by CIBMTR for those cases indicated 100% success of engraftment and 100% survival at 100 days post-infusion. Engraftment data reports indicated ANC > 500 was achieved within 6–30 days, and platelet count > 20,000 was achieved within 25–163 days. The transplant outcome of PF product is comparable to that reported historically for CRF CB products. Conclusions: In vitro results and clinical findings support the quality and safety of HPC products cryopreserved using PF methodology and would recommend PF as valid alternative to the use of CRF systems. Disclosures: No relevant conflicts of interest to declare.
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Bordin, JO, NM Heddle, and MA Blajchman. "Biologic effects of leukocytes present in transfused cellular blood products." Blood 84, no. 6 (September 15, 1994): 1703–21. http://dx.doi.org/10.1182/blood.v84.6.1703.1703.
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Abstract A considerable literature has accumulated over the past decade indicating that leukocytes present in allogeneic cellular blood components, intended for transfusion, are associated with adverse effects to the recipient. These include the development of febrile transfusion reactions, graft-versus-host disease, alloimmunization to leukocyte antigens, and the immunomodulatory effects that might influence the prognosis of patients with a malignancy. Moreover, it has become evident that such leukocytes may be the vector of infectious agents such as CMV, HTLV-I/II, and EBV as well as other viruses. An interesting development that has occurred coincidentally in transfusion medicine is that agencies responsible for the provision of blood products are being designated manufacturers of biologicals. The trend among manufacturers of biologicals is to try to produce pure products to provide for the specific therapeutic need of patients. Thus, with the realization that allogeneic leukocytes and their products may have adverse biologic activities, there is increasing pressure from various sources for the reduction of the leukocyte content in allogeneic blood components to minimize the occurrence of their adverse effects. Although the threshold leukocyte number below which these effects might no longer occur is still to be determined, a 2 to 3 log10 leukocyte reduction, provided by the currently available commercial leukocyte filters, has been shown to reduce the frequency of many of such reactions. On the other hand, the immunosuppressive effects produced by the infusion of allogeneic leukocytes might be beneficial for some patients, ie, for the maintenance of kidney allografts, in possibly reducing the relapse rate in patients with inflammatory bowel diseases, and in ameliorating recurrent spontaneous abortion. Moreover, therapeutic granulocyte transfusions may be of benefit in certain well- defined categories of patients infected with bacteria, yeast, and/or fungi. These include neonates with bacterial sepsis associated with bone marrow failure as well as severely neutropenic leukemic patients with an infection unresponsive to appropriate and specific antibiotic therapy. Many of the results obtained with the use of leukocyte depletion filters are tantalizing, but the actual clinical benefit of leukodepletion has not been established in most instances, because much of the available data are retrospective or from uncontrolled clinical trials. Moreover, issues of cost-effectiveness and quality control have not been considered adequately. Properly designed prospective clinical trials are essential to provide data with which to answer such questions and also to help define the optimal conditions required for the preparation of blood components ultimately destined for clinical use. Only with the availability of such data can sound decisions be made about the clinical value of leukodepletion.
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Bordin, JO, NM Heddle, and MA Blajchman. "Biologic effects of leukocytes present in transfused cellular blood products." Blood 84, no. 6 (September 15, 1994): 1703–21. http://dx.doi.org/10.1182/blood.v84.6.1703.bloodjournal8461703.
Full textAbstract:
A considerable literature has accumulated over the past decade indicating that leukocytes present in allogeneic cellular blood components, intended for transfusion, are associated with adverse effects to the recipient. These include the development of febrile transfusion reactions, graft-versus-host disease, alloimmunization to leukocyte antigens, and the immunomodulatory effects that might influence the prognosis of patients with a malignancy. Moreover, it has become evident that such leukocytes may be the vector of infectious agents such as CMV, HTLV-I/II, and EBV as well as other viruses. An interesting development that has occurred coincidentally in transfusion medicine is that agencies responsible for the provision of blood products are being designated manufacturers of biologicals. The trend among manufacturers of biologicals is to try to produce pure products to provide for the specific therapeutic need of patients. Thus, with the realization that allogeneic leukocytes and their products may have adverse biologic activities, there is increasing pressure from various sources for the reduction of the leukocyte content in allogeneic blood components to minimize the occurrence of their adverse effects. Although the threshold leukocyte number below which these effects might no longer occur is still to be determined, a 2 to 3 log10 leukocyte reduction, provided by the currently available commercial leukocyte filters, has been shown to reduce the frequency of many of such reactions. On the other hand, the immunosuppressive effects produced by the infusion of allogeneic leukocytes might be beneficial for some patients, ie, for the maintenance of kidney allografts, in possibly reducing the relapse rate in patients with inflammatory bowel diseases, and in ameliorating recurrent spontaneous abortion. Moreover, therapeutic granulocyte transfusions may be of benefit in certain well- defined categories of patients infected with bacteria, yeast, and/or fungi. These include neonates with bacterial sepsis associated with bone marrow failure as well as severely neutropenic leukemic patients with an infection unresponsive to appropriate and specific antibiotic therapy. Many of the results obtained with the use of leukocyte depletion filters are tantalizing, but the actual clinical benefit of leukodepletion has not been established in most instances, because much of the available data are retrospective or from uncontrolled clinical trials. Moreover, issues of cost-effectiveness and quality control have not been considered adequately. Properly designed prospective clinical trials are essential to provide data with which to answer such questions and also to help define the optimal conditions required for the preparation of blood components ultimately destined for clinical use. Only with the availability of such data can sound decisions be made about the clinical value of leukodepletion.
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Zhi, Kaining, Babatunde Raji, Anantha R. Nookala, Mohammad Moshahid Khan, Xuyen H. Nguyen, Swarna Sakshi, Tayebeh Pourmotabbed, et al. "PLGA Nanoparticle-Based Formulations to Cross the Blood–Brain Barrier for Drug Delivery: From R&D to cGMP." Pharmaceutics 13, no. 4 (April 6, 2021): 500. http://dx.doi.org/10.3390/pharmaceutics13040500.
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The blood–brain barrier (BBB) is a natural obstacle for drug delivery into the human brain, hindering treatment of central nervous system (CNS) disorders such as acute ischemic stroke, brain tumors, and human immunodeficiency virus (HIV)-1-associated neurocognitive disorders. Poly(lactic-co-glycolic acid) (PLGA) is a biocompatible polymer that is used in Food and Drug Administration (FDA)-approved pharmaceutical products and medical devices. PLGA nanoparticles (NPs) have been reported to improve drug penetration across the BBB both in vitro and in vivo. Poly(ethylene glycol) (PEG), poly(vinyl alcohol) (PVA), and poloxamer (Pluronic) are widely used as excipients to further improve the stability and effectiveness of PLGA formulations. Peptides and other linkers can be attached on the surface of PLGA to provide targeting delivery. With the newly published guidance from the FDA and the progress of current Good Manufacturing Practice (cGMP) technologies, manufacturing PLGA NP-based drug products can be achieved with higher efficiency, larger quantity, and better quality. The translation from bench to bed is feasible with proper research, concurrent development, quality control, and regulatory assurance.
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Lobovikova, O. A., I. V. Shul'gina, E. G. Abramova, A. K. Nikiforov, A. V. Komissarov, V. A. Demchenko, A. G. Selezneva, A. S. Fes'kova, S. S. Galetova, and N. P. Mironova. "REGISTRATION DOCUMENTATION AND AMENDMENTS TO IT AS AN ELEMENT OF A QUALITY MANAGEMENT SYSTEM IN PRODUCTION OF ANTI-RABIES IMMUNOGLOBULIN (REVIEW)." Drug development & registration 8, no. 1 (February 14, 2019): 92–96. http://dx.doi.org/10.33380/2305-2066-2019-8-1-92-96.
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Introduction. Documentation is an integral part of the quality management system, a key element of production and quality control of medicines. A necessary condition for the Rules of good manufacturing practice and guaranteed production of quality products is compliance with the requirements set out in the documents of the registration dossier for the drug. During the life cycle of a drug, post-registration changes in the dossier may be required. Text. This work is an analytical review of changes in the documents of the registration dossier for the drug «Immunoglobulin antirabic from horse blood serum liquid», solution for injections, reflecting the improvement of biotechnology of drug production and methods of its control in the post – registration period. The first post-registration changes in the regulatory documentation were administrative in nature and did not require examination of samples of the drug. The next group of changes in the documents of the registration dossier was due to the expansion of production, reconstruction of technological sites and the introduction of innovative technologies in order to comply with the requirements of GMP, as well as improving the consumer properties of the drug. The last group of changes concerned the revision of methods of quality control of finished products associated with the introduction of modern analytical equipment, expanding the list of standards and bringing into compliance with the requirements of the state Pharmacopoeia XIII edition. Conclusion. The timely introduction of changes into documents of the registration dossier allows you to optimize the procedure for the conduct of internal and external control of rabies immunoglobulin, as well as to avoid violations related to the actualization of the technological documentation. The analysis of changes in the documents of the registration dossier for the drug «Immunoglobulin antirabic from horse blood serum liquid», solution for injections, reflecting the improvement of biotechnology of drug production and methods of its control in the post-registration period. Timely changes in the documents of the registration dossier allow to optimize the procedure of internal and external quality control of anti-rabies immunoglobulin, as well as to avoid violations associated with the updating of technological documentation.
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Fast, Loren D., Susanne Marschner, Gilbert DiLeone, Suzann K. Doane, and Raymond P. Goodrich. "Inactivation of Human White Blood Cells in Red Blood Cell Products Using Mirasol® Pathogen Reduction Technology (PRT)." Blood 108, no. 11 (November 16, 2006): 4135. http://dx.doi.org/10.1182/blood.v108.11.4135.4135.
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Abstract The transfusion of blood products can result in transmission of pathogens and immunological consequences such as transfusion associated graft-versus-host disease and alloimmunization. Previous studies have shown that exposure of platelet concentrates to riboflavin and light (Mirasol PRT treatment) causes irreparable modification of nucleic acids that results in inactivation of a wide range of pathogens as well as inhibition of the immunological responses mediated by the WBC present in platelet concentrates. Initial studies investigated the effects of Mirasol PRT treatment of RBC concentrates on WBC function. Human peripheral blood mononuclear cells (PBMNC) were purified by Ficoll-Hypaque discontinuous centrifugation from control or test non-leukoreduced RBC units exposed to riboflavin and varying doses of light. These PBMNC were tested for their ability to be activated in response to PMA, to proliferate in response to PHA or allogeneic stimulator cells, and to stimulate proliferative responses of allogeneic responder cells. While lower light doses were sufficient to inhibit activation and proliferation, higher energies (30J/ml RBC) were required for inhibition of antigen presentation. These Mirasol treatment conditions did not induce crossmatch incompatibility, methemoglobin (MetHb) levels stayed within an acceptable range (2.6% + 1.5) and hemolysis was below 1% during storage. Interestingly, MetHb levels decreased to background levels during storage at 4°C, suggesting that the activity of the enzyme NADH methemoglobin reductase was not compromised by the exposure to riboflavin and light. These treatment conditions also reduced levels of Gram positive and negative bacteria to the limits of detection and reduced infectivity of both enveloped and non-eveloped viruses by > 4 logs on average in packed, washed RBC units. In summary, Mirasol PRT is able to functionally inactivate WBCs and pathogens in washed RBC products without adversely affecting the quality of the RBCs. This novel pathogen reduction therapy for RBC products complements the Mirasol PRT treatment for platelets and offers inactivation of pathogens in cellular blood components using a single technology.
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Murphy, Lindsey A., Russell Marians, Mark Eric Kohler, Terry J. Fry, and Amanda C. Winters. "Detection of Vector Copy Number in Bicistronic CD19xCD22 CAR T Cell Products with Digital PCR." Blood 138, Supplement 1 (November 5, 2021): 4001. http://dx.doi.org/10.1182/blood-2021-153889.
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Abstract Chimeric antigen receptor (CAR) T cell therapy is a rapidly evolving immunotherapeutic treatment modality for adult and pediatric patients with a variety of cancers, which has been most extensively investigated in B-cell malignancies. Given that CAR T cell immunotherapy involves changing the genetic composition of a patient's T cells, this living drug presents unique safety and quality control challenges. Vector copy number (VCN), a measurement of transgene copies within a CAR T cell product, is a product-specific characteristic that must be quantified prior to patient administration as high VCN increases the risk of insertional mutagenesis. Historically, VCN assessment in CAR T cell products has been performed via qPCR. qPCR is reliable along a broad range of concentrations but has inherent limitations in its lower limit of detection and limit of quantification. Digital PCR (dPCR) methods were developed for absolute quantification of target sequences by counting nucleic acid molecules encapsulated in discrete, volumetrically defined partitions. Advantages of dPCR compared to qPCR include simplicity, reproducibility, lower limit of detection, and definitive quantification. In this present study, we developed an assay for analysis of the novel bicistronic UCD19x22 CAR T cell construct, which was developed in the laboratory of Dr. Terry Fry at the University of Colorado and will be moving in to clinical trials later this year. Custom primer-probe assays were designed using Primer Express v3.0.1 and the ThermoFisher Custom TaqMan Assay Design Tool. As an internal control, forward and reverse primers as well as a VIC-labeled probe specific to human albumin (NCBI gene 213, HGNC:399) were designed. Primers and a FAM-labeled probe assay, specific for the bicistronic CD19x22 CAR T cell product, were designed at the junction site between the two distinct CARs. This study compares two different digital PCR modalities: (1) droplet digital PCR (ddPCR) via the BioRad QX200 system which utilizes water-in-oil droplet partitions and (2) the QIAcuity digital PCR system utilizing a nanoplate-based partitioning platform. While dPCR is a newer methodology compared to ddPCR, the two apply parallel procedures, data generation, and analyses. The primer/probe assay was validated with qPCR, dPCR and ddPCR using patient samples from preclinical CAR T cell manufacturing production runs, as well as Jurkat cell subclones which stably express this bicistronic CAR T product. We successfully developed an assay to specifically detect and quantify our bicistronic CD19xCD22 CAR transgene. ddPCR confirmed the specificity of this assay to detect only the bicistronic CAR product without any signal detected in samples containing untransduced T cells or T cells transduced with CD19 only CARs. Additionally, our assay gives accurate, precise, and reproducible CAR T cell VCN measurements across qPCR, dPCR, and ddPCR modalities. We demonstrate that digital PCR strategies can be utilized for absolute quantification of CAR transgenes and VCN measurements, and that specific assays can be developed for detection of unique constructs. Future studies will evaluate the utility of this assay with digital PCR modalities in measuring CAR T cell persistence in clinical trial patient samples after receiving this novel CAR T cell product. Figure 1 Figure 1. Disclosures Fry: Sana Biotechnology: Current Employment, Current equity holder in publicly-traded company.
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Teoh, Jeffrey, Timothy G. Johnstone, Brian Christin, Rachel Yost, Neil A. Haig, Mary Mallaney, Aditya Radhakrishnan, et al. "Lisocabtagene Maraleucel (liso-cel) Manufacturing Process Control and Robustness across CD19+ Hematological Malignancies." Blood 134, Supplement_1 (November 13, 2019): 593. http://dx.doi.org/10.1182/blood-2019-127150.
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Background Lisocabtagene maraleucel (liso-cel) is an investigational, CD19-directed, genetically modified, autologous cellular immunotherapy administered as a defined composition of CD8+ and CD4+ components to deliver target doses of viable chimeric antigen receptor (CAR) T cells from both components. The CAR comprises a CD19-specific scFv and 4-1BB-CD3ζ endodomain. Liso-cel is being developed for the treatment of multiple B cell malignancies, including relapsed/refractory large B cell non-Hodgkin lymphoma (NHL) and chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL). The liso-cel manufacturing process design includes controls that enable robustness across heterogeneous patient populations and disease indications, minimizing between-lot variability. This is highlighted by consistency in process duration, reduction of terminally differentiated T cells present in the T cell starting material, and consistency in T cell purity across B cell NHL and CLL/SLL indications. Methods The liso-cel manufacturing process involves selection of CD8+ and CD4+ T cells from leukapheresis, followed by independent CD8+ and CD4+ activation, transduction, expansion, formulation, and cryopreservation. Liso-cel was manufactured in support of the TRANSCEND NHL 001 (NCT02631044) and TRANSCEND CLL 004 (NCT03331198) clinical trials. Phenotypic analysis of T cell and B cell composition from leukapheresis, T cell starting material, and CAR T cell product was performed by flow cytometry. Molecular characterization of T cell receptor (TCR) clonality was estimated from the T cell starting material and CAR T cell product through transcriptional profiling. Results Liso-cel manufacturing process optimizations have been implemented in advance of commercialization. These optimizations have significantly improved process duration consistency (Figure 1; F test P=4.1×10−36). Both phenotypic and molecular TCR clonality analyses demonstrated a significant reduction in terminally differentiated CD8+ T cells across the manufacturing process. Frequencies of CD45RA+ CCR7− populations were measured by flow cytometry in CD8+ T cell starting material (median=35.1%) and CAR T cell product (median=11.7%; Wilcoxon rank sum P=3.1×10−25). Characterization of TCR clonality showed a significant decrease in clonality in the CAR T cell product compared with T cell starting material (Wilcoxon rank sum P=5.6×10−6), suggesting selective expansion of clonally diverse, less differentiated T cell populations. These findings are supported by the predominant memory T cell composition observed in liso-cel. Manufacturing process robustness enabled by in-process T cell selection is further demonstrated by the capability to produce highly pure T cell products across heterogeneous patient populations and different disease indications. T cell and B cell composition were characterized in the leukapheresis, selected T cell material, and CAR T cell product, demonstrating consistent clearance of non-T cells, including CD19+ B cells in both B- cell NHL and CLL/SLL patient cohorts. Although the CD19+ B cell composition is significantly higher in leukapheresis from patients with CLL/SLL (median=10.0% of leukocytes) compared with B cell NHL patients (median=0.0% of leukocytes, Wilcoxon rank sum P=1.6×10−9), CAR T cell products manufactured from both CLL/SLL and B cell NHL patient populations consistently demonstrated clearance of non-T cells, including CD19+ cells, to below levels of quantitation. Conclusion Despite variation between B cell NHL and CLL/SLL patient leukapheresis, T cell enrichment before activation and transduction enables consistent downstream process performance and T cell purity, and a substantially reduced risk of transducing residual tumor cells. In addition, the reduction of terminally differentiated effector T cells and capacity to retain T cell diversity further improved consistency in product quality. Taken together, process modifications have enabled consistent manufacturing duration and quality of liso-cel product, which support operational efficiency and scalability for commercial production. Disclosures Teoh: Juno Therapeutics, a Celgene Company: Employment, Equity Ownership. Johnstone:Juno Therapeutics, a Celgene Company: Employment, Patents & Royalties: Author on a number of patent applications and invention disclosures relating to cell therapy and immunosequencing. Christin:Juno Therapeutics, a Celgene Company: Employment, Equity Ownership. Yost:Juno Therapeutics, a Celgene Company: Employment, Equity Ownership. Haig:Juno Therapeutics, a Celgene Company: Employment, Equity Ownership. Mallaney:Juno Therapeutics, a Celgene Company: Employment. Radhakrishnan:Juno Therapeutics, a Celgene Company: Employment, Equity Ownership. Gillenwater:Juno Therapeutics, a Celgene Company: Employment, Equity Ownership. Albertson:Juno Therapeutics, a Celgene Company: Employment, Equity Ownership. Guptill:Juno Therapeutics, a Celgene Company: Employment. Brown:Juno Therapeutics, a Celgene Company: Employment. Ramsborg:Juno Therapeutics, a Celgene Company: Employment, Equity Ownership, Patents & Royalties: Numerous patents. Hause:Juno Therapeutics, a Celgene Company: Employment, Equity Ownership. Larson:Juno Therapeutics, a Celgene Company: Employment, Equity Ownership.
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Korotkyi, O., L. Kot, K. Dvorshchenko, and L. Ostapchenko. "Oxidative modification of proteins in rat serum under experimental osteoarthritis and joint administration of a chondroprotector and multiprobiotic." Bulletin of Taras Shevchenko National University of Kyiv. Series: Biology 81, no. 2 (2020): 64–68. http://dx.doi.org/10.17721/1728_2748.2020.81.64-68.
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One of the actual problems of modern medicine is joint disease. Among them, osteoarthritis occupies an important place. The formation of osteoarthritis is accompanied by the development of inflammation, which leads to damage to all structures of the joint. An important role in inflammatory processes is played by the intensification of free radical processes. As the disease develops, the joints lose their mobility, which leads to a decrease in the quality of life of patients and the development of disability. In this regard, it is important to search for drugs that have regenerative, anti-inflammatory and antiradical properties. The aim of our study was to investigate the combined effect of chondroitin sulfate and multiprobiotic on the content of oxidative protein modification products and the level of sulfhydryl groups in rat blood serum under conditions of monoiodoacetate-induced osteoarthritis. The study included participation of white male non-linear rats (weighing 180–240 g) adherence to the general ethical principles of animal experiments. An experimental osteoarthritis model was created by introducing 1 mg of sodium monoiodoacetate into the knee ligament. Chondroitin sulfate and multiprobiotic were used as therapeutic agents. The content of products of oxidative modification of proteins was determined by the level of carbonyl derivatives, which are manifested in the reaction with 2,4-dinitrophenylhydrazine. The level of total, protein-bound and non-protein sulfhydryl groups was measured by the Elman method. It was found that under conditions of monoiodoacetate-induced osteoarthritis in the blood serum of rats, the content of products of oxidative modification of proteins increases. The level of neutral aldehyde products (E max = 356 nm) is increased by 2.5 times and neutral ketone products (E max = 370 nm), respectively, by 2,1 times compared to the control. Under the same experimental conditions in the blood serum, the amount of basic aldehyde products (E max = 430 nm) increases by 1.9 times, while the content of the main ketone products (E max = 530 nm) increases by 1,7 times compared to the control groups. In experimental osteoarthritis in the blood serum, the content of sulfhydryl groups decreases: non-protein SH-groups – 1,5 times, protein and general SH-groups – 1,7 times relative to the control. This indicates disturbance of the oxidative-antioxidant balance and the development of oxidative stress in the organism during experimental osteoarthritis. It was shown that the combined administration of chondroitin sulfate and multiprobiotics in animals with experimental osteoarthritis partially restored the above parameters.
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Chun, Haarin, John R. Pettersson, Svetlana A. Shestopal, Wells W. Wu, Ekaterina S. Marakasova, Philip Olivares, Stepan S. Surov, et al. "Characterization of Protein Unable to Bind Von Willebrand Factor in Recombinant Factor VIII Products: Can We Reduce Their Immunogenicity?" Blood 136, Supplement 1 (November 5, 2020): 25–26. http://dx.doi.org/10.1182/blood-2020-133286.
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Introduction Therapeutic products with blood coagulation factor VIII (FVIII) have a wide range of protein contents per activity unit (or IU/mg, specific activity), available from previous studies (Lin et al, 2004; Butenas et al, 2009) and the prescribing information. The wide range of the specific activities seems to be more pronounced in recombinant FVIII products (rFVIII) compared to plasma-derived FVIII, implying presence of protein with altered structure and biochemical properties. In particular, rFVIII products were reported to contain a protein fraction (FVIII*), unable to bind von Willebrand factor (VWF) without functional activity (Lin et al, 2004;Ofosu et al 2012). Furthermore, FVIII* may represent a risk factor for development of FVIII inhibitors in Hemophilia A patients, as the binding to VWF was shown to reduce FVIII immunogenicity in a tissue culture and mice model systems (Gangadharan et al, 2017; Muczynski et al, 2018). Due to these reasons, FVIII* can be defined as an impurity, which needs to be understood and controlled in rFVIII products. Study objective To develop a methodology to isolate FVIII* from rFVIII samples and to characterize this fraction in various rFVIII products. Experimental design Using immobilized VWF affinity chromatography (IVAC) for analysis of FVIII samples, protein fractions collected from (i) the column flow-through (FVIIIFT, corresponding to FVIII*) and (ii) the column-bound and eluted fraction (FVIIIEL) were characterized using polyacrylamide gel electrophoresis (PAGE) gels followed by silver-staining and immunoblotting, FVIII activity test, surface plasmon resonance, mass spectrometry, and for plasma clearance in mice. Results A robust IVAC methodology was developed. Using this method, we isolated the FVIIIFT and FVIIIEL from all ten third-generation rFVIII products marketed in the USA by study time. These products represent all current pharmaceutical variants of rFVIII including full-size FVIII, B-domain deleted (truncated) FVIII, Fc-fused FVIII, single-chained FVIII, and PEGylated protein, including those with the extended plasma half-life. FVIIIFT was found in all rFVIII products at levels up to 22% of total protein. Compared to FVIIIEL, FVIIIFT had similar pattern of polypeptide bands by PAGE, but lower functional activity, significantly reduced sulfation at Tyr1680 important for VWF binding, moderately decreased interaction with recombinant cluster II of a low-density lipoprotein receptor related protein 1 (a major clearance receptor of FVIII), and approximately 3-times faster clearance in mice (Figure 1). Conclusions Our results show that the FVIII* structure is generally similar to that of the major fraction of rFVIII, while it differs by microheterogeneity in post-translational modifications and possibly local misfolding. The data suggest that upon administration of a rFVIII product in patients, its FVIII* fraction is rapidly removed from the circulation, resulting in a decrease of the effective dosage. Our findings demonstrate a potential of IVAC to control FVIII* fraction in rFVIII products, including its removal from the products during their manufacture. These applications may lead to achieving better quality and efficacy of rFVIII products including reduction of their immunogenicity for improving the care of Hemophilia A. Disclosures No relevant conflicts of interest to declare.
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Passerini, Heather M. "Contemporary Transfusion Science and Challenges." AACN Advanced Critical Care 30, no. 2 (June 15, 2019): 139–50. http://dx.doi.org/10.4037/aacnacc2019462.
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Health care professionals must understand the impact of blood product transfusions and transfusion therapy procedures to ensure high-quality patient care, positive outcomes, and wise use of resources in blood management programs. Understanding transfusions of blood and blood products is also important because of the number of treatments performed, which affects individual patients and health care system resources. This article reviews research findings to acquaint health care professionals with the most successful protocols for blood, blood product, and coagulation factor transfusions. Damage control resuscitation in bleeding trauma patients, protocols for patients without trauma who are undergoing surgical procedures that place them at risk for excessive bleeding, and protocols for patients with sepsis are addressed. Emerging research continues to help guide mass transfusion treatments (restrictive vs liberal, balanced, and goal-directed treatment). Although available study results provide some guidance, questions remain. Additional research by health care professionals is needed.
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Perveen, Samina, Imran Hashmi, and Romana Khan. "Evaluation of genotoxicity and hematological effects in common carp (Cyprinus carpio) induced by disinfection by-products." Journal of Water and Health 17, no. 5 (July 23, 2019): 762–76. http://dx.doi.org/10.2166/wh.2019.261.
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Abstract Disinfection is intended to improve drinking water quality and human health. Although disinfectants may transform organic matter and form disinfection by-products (DBPs), many are branded as cyto- and genotoxic. Traditionally, research focuses on the effects of DBPs on human health, but cytogenic impacts on aquatic organisms still remain ill defined. The current study examines the potential toxic effect of chloroform and iodoform (DBPs) on Cyprinus carpio, selected as a model organism. Fish specimens were exposed to various concentrations of DBPs primarily based on LD50 values, where acute toxicity was monitored for 96 h. Headspace SPME extraction through gas chromatography was employed to assess the effects of spiked DBPs doses in fish blood. Cytotoxicity was monitored using Comet assay. Tail length, tail DNA, and olive tail moment values were quantified to be significant (P < 0.05) as compared to control. A statistically significant (P < 0.05) decrease in all blood parameters (hematology) was observed. Changes in biochemical indices (glucose, total protein, and alanine aminotransferase (ALT)) were also significant. ALT secretion was significantly increased (93 ± 0.05 and 82.8 ± 0.1 U/L) at higher concentration compared to control (56 ± 0.1 U/L), suggesting liver damage. Results demonstrated that iodoform was statistically more damaging as compared to chloroform.
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Maddens, Stephane, Eric Petitprost, Isabelle Bardey, Christian Lamy, Francine Garnache, Philippe Saas, Jacqueline Chabod, and Valerie Lapierre. "Quality Assurance Improvement during Accreditation Process of a French Cord Blood Bank: FACT No Fiction." Blood 106, no. 11 (November 16, 2005): 5284. http://dx.doi.org/10.1182/blood.v106.11.5284.5284.
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Abstract The Cord Blood Banks (CBB) wishing to be affiliated to NETCORD must demonstrate that they adopted the Fact-Netcord standards for collection, processing, quality control testing, storage, selection and release for their cord blood units (CBU). The best way to provide these assurances is to obtain FACT accreditation label. The Besancon Cord Blood Bank initiated this quality approach in January 2004 and was inspected on-site in June 2004.Initial internal audits revealed major deficiencies in specific Quality Management areas and the lack of an efficient documentation system together with adequate standard operating procedures and documented validation studies for each step of the process. Adequate labelling, conformity with good transport practices and post-transplantation clinical data recovery were also areas to be improved. Moreover, in order to clarify the different pathways of material, cell products, staff, or wastes, several building works modifications had to be undertaken. Several major improvements were performed during those six months of Fact accreditation project. The Assurance Quality Information System was significantly upgraded to control all the major elements of assurance quality (staff formation, material, premises, alarms, cleaning, records, and quality control testing) by implementing a computerised Oracle-based application. Morover, all documentation was implemented on an intranet network and is now easily accessible to all the staff wherever in the facility. In order to improve the volume of CBU, a weigh-and-mix machine used for blood donor harvesting procedure was tailored for specific CBU collection. To improve the conditions of transport we set up special containers with controlled temperature continuously monitored. Finally, major validation study was performed on a short period, aiming at demonstrating efficiency and reproducibility of the overall CBU process. In brief, eligible mothers, who give their informed consent, are accepted for CB donation after a medical interview. Collection is performed with the placenta in utero. The delay between collection and processing must not exceed 24hrs. CBU volumes are reduced using Sepax© (Biosafe, Switzerland) technology for long-term storage in a Bioarchive© (Thermogenesis, CA, USA). Quality controls include testing maternal blood samples for infectious markers (HIV, HCV, HBV, HTLV, syphilis) and the presence of IGg- and IgM-antibodies against toxoplasmosis, EBV and CMV on the day of birth and after a quarantine period of at least 60 days. No active infectious disease is mandatory. A baby’s clinical examination is performed at the same time point. Microbiological tests on the CBU must be negative. In addition, our CBB requires a minimal collection volume of 80 ml and a minimum of 2 x 106 CD34 cells for CBU qualification. We implemented a systematic cord blood haemoglobin analysis and tested systematically cord blood plasma for viral infection by genomic detection. Finally, our bank obtained its FACT accreditation on May 2nd 2005, validating our strategy. This achievement had a great impact on CBB staff, desiring to maintain and improve their know how. On June 30th 2005, 5045 CBU were registered at French marrow registry and 273 (5%) were transplanted, 142 (52%) in France and 131 (48%) in other countries. This high 5% transplantation rate may be due to the stringent initial quality controls requirements.
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Marling, Cindy, Matthew Wiley, Razvan Bunescu, Jay Shubrook, and Frank Schwartz. "Emerging Applications for Intelligent Diabetes Management." AI Magazine 33, no. 2 (March 16, 2012): 67. http://dx.doi.org/10.1609/aimag.v33i2.2410.
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Diabetes management is a difficult task for patients, who must monitor and control their blood glucose levels in order to avoid serious diabetic complications. It is a difficult task for physicians, who must manually interpret large volumes of blood glucose data to tailor therapy to the needs of each patient. This paper describes three emerging applications that employ AI to ease this task: (1) case-based decision support for diabetes management; (2) machine learning classification of blood glucose plots; and (3) support vector regression for blood glucose prediction. The first application provides decision support by detecting blood glucose control problems and recommending therapeutic adjustments to correct them. The second provides an automated screen for excessive glycemic variability. The third aims to build a hypoglycemia predictor that could alert patients to dangerously low blood glucose levels in time to take preventive action. All are products of the 4 Diabetes Support SystemTM project, which uses AI to promote the health and wellbeing of people with type 1 diabetes. These emerging applications could potentially benefit 20 million patients who are at risk for devastating complications, thereby improving quality of life and reducing health care cost expenditures.
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Kashirina, Lidia, Konstantin Ivanischev, and Kirill Romanov. "The effect of antioxidant drugs on veterinary and sanitary parameters of cow’s milk." E3S Web of Conferences 222 (2020): 02014. http://dx.doi.org/10.1051/e3sconf/202022202014.
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The article presents the results of experimental studies to determine the effect of antioxidant drugs “Butofan” and “E-selenium” on veterinary and sanitary parameters of cows’ milk obtained in the period after calving. Childbirth is characterized by a stressful physiological state of the body and a large amount of lipid peroxidation (LPO) products are formed in the blood of cows, which have a negative depleting effect on the body and, naturally, on the quality of milk, since it is a blood product. To enhance the work of the body’s own antioxidant system, since it is not always enough to neutralize LPO products, antioxidant drugs are used. It is necessary to determine veterinary and sanitary parameters in milk obtained under the influence of any drugs, since it is used in human nutrition. For this purpose, experimental studies were carried out on analogous dairy cows in one of the farms of Ryazan region. The cows were divided into three groups: the control and two experimental ones. The control group of animals was intact, the cows of the experimental groups received antioxidant preparations: the first one got “E-selenium” and the second one got “Butofan”. The research results showed that the milk yield of cows in the experimental groups was higher compared to the control. The quality parameters of milk in the experimental groups of cows were better in terms of fat content, protein content, density and acidity. Cow’s milk under the influence of antioxidant drugs was biologically complete and environmentally friendly.