Inhaltsverzeichnis
Auswahl der wissenschaftlichen Literatur zum Thema „Production clinique grade GMP“
Geben Sie eine Quelle nach APA, MLA, Chicago, Harvard und anderen Zitierweisen an
Machen Sie sich mit den Listen der aktuellen Artikel, Bücher, Dissertationen, Berichten und anderer wissenschaftlichen Quellen zum Thema "Production clinique grade GMP" bekannt.
Neben jedem Werk im Literaturverzeichnis ist die Option "Zur Bibliographie hinzufügen" verfügbar. Nutzen Sie sie, wird Ihre bibliographische Angabe des gewählten Werkes nach der nötigen Zitierweise (APA, MLA, Harvard, Chicago, Vancouver usw.) automatisch gestaltet.
Sie können auch den vollen Text der wissenschaftlichen Publikation im PDF-Format herunterladen und eine Online-Annotation der Arbeit lesen, wenn die relevanten Parameter in den Metadaten verfügbar sind.
Zeitschriftenartikel zum Thema "Production clinique grade GMP"
1
Derenne, S., K. Tertrais, A. G. Chartois, F. Auffray, B. Clemenceau und H. Vie. „Production de MTI de grade clinique par l’EFS Atlantic Bio GMP : transposition d’échelle, validation et production de lymphocytes T cytotoxiques anti-CMV tierce partie“. Transfusion Clinique et Biologique 20, Nr. 3 (Juni 2013): 277. http://dx.doi.org/10.1016/j.tracli.2013.04.085.
Der volle Inhalt der Quelle
2
Rudiyanto, Heru. „The Study of Good Manufacturing Practices (GMP) and Good Quality Wingko Based on SNI-01-4311-1996“. JURNAL KESEHATAN LINGKUNGAN 8, Nr. 2 (05.07.2016): 148. http://dx.doi.org/10.20473/jkl.v8i2.2016.148-157.
Der volle Inhalt der QuelleAnnotation:
Abstract: Wingko is a special snack from Kecamatan Babat, Kabupaten Lamongan. One of home industries that produce Wingko in Babat City is UD. Bintang Jaya. The making process of Wingko is done traditionally, by using human power. It is really possible for microorganisms to contaminate and affect the quality of Wingko through this process. To raise the quality of food, food controlling is badly needed. Good Manufacturing Practices (GMP) is one of systems that describes the terms that have to be fulfi lled by home industries. The purpose of this research is to identify the production of wingko according to GMP perspective and the quality of Wingko based on SNI-01-4311-1996, and to make GMP plan for the home industries. This is an observational research. Based on the data, this research is observational descriptive, while according to the period of the research, this is a crossectional research. The sample for this research is Wingko, the owner and the employees whoever involve in the production. The variable in this research consists of staple, employees health, production tools, location and facilitations, E.coli and sweetener (saccharin and cyclamate), and last but not least the sensory aspects. The research shows the good categorized variables are: staple, production tools, health employees sensory aspects. Meanwhile the adequate categorized are: location and facilitations. The result of laboratory test over E.coli and sweetener, shows that these are qualifi ed based on SNI 01-4311-1996 about Wingko’s grade standard. The variables that don’t meet the qualifi cations of (GMP), are suggested to be improved to make better results and more qualified, while the qualifi ed variables based on GMP are expected to keep their good conditions.Keywords: Wingko, Food Grade Quality, GMP
3
Lechanteur, Chantal, Alexandra Briquet, Virginie Bettonville, Etienne Baudoux und Yves Beguin. „MSC Manufacturing for Academic Clinical Trials: From a Clinical-Grade to a Full GMP-Compliant Process“. Cells 10, Nr. 6 (26.05.2021): 1320. http://dx.doi.org/10.3390/cells10061320.
Der volle Inhalt der QuelleAnnotation:
Following European regulation 1394/2007, mesenchymal stromal cell (MSCs) have become an advanced therapy medicinal product (ATMP) that must be produced following the good manufacturing practice (GMP) standards. We describe the upgrade of our existing clinical-grade MSC manufacturing process to obtain GMP certification. Staff organization, premises/equipment qualification and monitoring, raw materials management, starting materials, technical manufacturing processes, quality controls, and the release, thawing and infusion were substantially reorganized. Numerous studies have been carried out to validate cultures and demonstrate the short-term stability of fresh or thawed products, as well their stability during long-term storage. Detailed results of media simulation tests, validation runs and early MSC batches are presented. We also report the validation of a new variant of the process aiming to prepare fresh MSCs for the treatment of specific lesions of Crohn’s disease by local injection. In conclusion, we have successfully ensured the adaptation of our clinical-grade MSC production process to the GMP requirements. The GMP manufacturing of MSC products is feasible in the academic setting for a limited number of batches with a significant cost increase, but moving to large-scale production necessary for phase III trials would require the involvement of industrial partners.
4
Kierkels, Guido J. J., Trudy Straetemans, Moniek A. de Witte und Jürgen Kuball. „The next step toward GMP-grade production of engineered immune cells“. OncoImmunology 5, Nr. 2 (27.08.2015): e1076608. http://dx.doi.org/10.1080/2162402x.2015.1076608.
Der volle Inhalt der Quelle
5
Heshusius, Steven, Esther Heideveld, Patrick Burger, Marijke Thiel-Valkhof, Erica Sellink, Eszter Varga, Elina Ovchynnikova et al. „Large-scale in vitro production of red blood cells from human peripheral blood mononuclear cells“. Blood Advances 3, Nr. 21 (04.11.2019): 3337–50. http://dx.doi.org/10.1182/bloodadvances.2019000689.
Der volle Inhalt der QuelleAnnotation:
Key Points This article provides a defined GMP-grade medium and erythroid culture protocol, resulting in >90% enucleated RBC. This article provides a high-resolution database of RNA expression dynamics at daily intervals during terminal erythroid differentiation.
6
Aussel, Clotilde, Elodie Busson, Helene Vantomme, Juliette Peltzer und Christophe Martinaud. „Quality assessment of a serum and xenofree medium for the expansion of human GMP-grade mesenchymal stromal cells“. PeerJ 10 (30.05.2022): e13391. http://dx.doi.org/10.7717/peerj.13391.
Der volle Inhalt der QuelleAnnotation:
Background Cell-based therapies are emerging as a viable modality to treat challenging diseases, resulting in an increasing demand for their large-scale, high-quality production. Production facilities face the issue of batch-to-batch consistency while producing a safe and efficient cell-based product. Controlling culture conditions and particularly media composition is a key factor of success in this challenge. Serum and Xeno-Free Media (SXFM) represent an interesting option to achieve this goal. By reducing batch to batch variability, they increase Good Manufacturing Practices (GMP)-compliance and safety regarding xenogenic transmission, as compared to fetal bovine serum (FBS) supplemented-media or human platelet lysate supplemented medium. Methods In this study, the isolation, expansion and characteristics including the anti-inflammatory function of human mesenchymal stromal cells (MSC) are compared after culture in MEMα supplemented with human Concentrate Platelet Lysate (hCPL, reference medium) or in MSC-Brew GMP Medium. The latter is a GMP SXFM manufactured in bags under strictly controlled conditions in volumes suitable for expansion to a clinical scale and does not require neither pre-coating of the cell culture units nor the addition of blood derivatives at the isolation step. Results We showed that MSC derived from human bone-marrow and adipose tissue can be successfully isolated and expanded in this SXFM. Number and size of Colony-Forming Unit fibroblast (CFU-F) is increased compared to cells cultivated in hCPL medium. All cells retained a CD90+, CD73+, CD105+, HLADR−, CD34−, CD45− phenotype. Furthermore, the osteogenic and adipocyte potentials as well as the anti-inflammatory activity were comparable between culture conditions. All cells reached the release criteria established in our production facility to treat inflammatory pathologies. Conclusions The use of MSC-Brew GMP Medium can therefore be considered for clinical bioprocesses as a safe and efficient substitute for hCPL media.
7
Chauvierre, Cédric, Rachida Aid-Launais, Joël Aerts, Frédéric Chaubet, Murielle Maire, Lucas Chollet, Lydia Rolland et al. „Pharmaceutical Development and Safety Evaluation of a GMP-Grade Fucoidan for Molecular Diagnosis of Cardiovascular Diseases“. Marine Drugs 17, Nr. 12 (12.12.2019): 699. http://dx.doi.org/10.3390/md17120699.
Der volle Inhalt der QuelleAnnotation:
The adhesion molecule P-selectin is present on the cell surface of both activated endothelium and activated platelets. The present study describes the pharmaceutical development, safety evaluation, and preclinical efficacy of a micro-dosed radiotracer. The macromolecular nanoscale assembly consisted of a natural compound made of a sulfated fucose-rich polysaccharides (fucoidan) and a radionuclide (technetium-99m) for the detection of P-selectin expression in cardiovascular diseases. After extraction and fractionation from brown seaweeds, the good manufacturing practice (GMP) production of a low molecular weight (LMW) fucoidan of 7 kDa was achieved and full physicochemical characterization was performed. The regulatory toxicology study in rats of the GMP batch of LMW fucoidan revealed no adverse effects up to 400 μg/kg (×500 higher than the expected human dose) and pseudoallergy was not seen as well. In a myocardial ischemia-reperfusion model in rats, the GMP-grade LMW fucoidan labeled with technetium-99m detected P-selectin upregulation in vivo. The present study supports the potential of using 99mTc-fucoidan as an imaging agent to detect activated endothelium in humans.
8
Rusconi, Giulio, Giuseppe Cusumano, Luca Mariotta, Reto Canevascini, Mauro Gola, Rosalba Gornati und Gianni Soldati. „Upgrading Monocytes Therapy for Critical Limb Ischemia Patient Treatment: Pre-Clinical and GMP-Validation Aspects“. International Journal of Molecular Sciences 23, Nr. 20 (21.10.2022): 12669. http://dx.doi.org/10.3390/ijms232012669.
Der volle Inhalt der QuelleAnnotation:
Advanced cell therapy medicinal products (ATMP) are at the forefront of a new range of biopharmaceuticals. The use of ATMP has evolved and increased in the last decades, representing a new approach to treating diseases that are not effectively managed with conventional treatments. The standard worldwide recognized for drug production is the Good Manufacturing Practices (GMP), widely used in the pharma production of synthesized drugs but applying also to ATMP. GMP guidelines are worldwide recognized standards to manufacture medicinal products to guarantee high quality, safety, and efficacy. In this report, we describe the pre-clinical and the GMP upgrade of peripheral blood mononuclear cell (PBMC) preparation, starting from peripheral blood and ending up with a GMP-grade clinical product ready to be used in patients with critical limb ischemia (CLI). We also evaluated production in hypoxic conditions to increase PBMC functional activity and angiogenic potential. Furthermore, we extensively analyzed the storage and transport conditions of the final product as required by the regulatory body for ATMPs. Altogether, results suggest that the whole manufacturing process can be performed for clinical application. Peripheral blood collected by a physician should be transported at room temperature, and PBMCs should be isolated in a clean room within 8 h of venipuncture. Frozen cells can be stored in nitrogen vapors and thawed for up to 12 months. PBMCs resuspended in 5% human albumin solution should be stored and transported at 4 °C before injection in patients within 24 h to thawing. Hypoxic conditioning of PBMCs should be implemented for clinical application, as it showed a significant enhancement of PBMC functional activity, in particular with increased adhesion, migration, and oxidative stress resistance. We demonstrated the feasibility and the quality of a GMP-enriched suspension of monocytes as an ATMP, tested in a clean room facility for all aspects related to production in respect of all the GMP criteria that allow its use as an ATMP. We think that these results could ease the way to the clinical application of ATMPs.
9
Wagner, Michael, Johan G. Doverfjord, Joachim Tillner, Gunnar Antoni, Torsten Haack, Martin Bossart, Iina Laitinen et al. „Automated GMP-Compliant Production of [68Ga]Ga-DO3A-Tuna-2 for PET Microdosing Studies of the Glucagon Receptor in Humans“. Pharmaceuticals 13, Nr. 8 (31.07.2020): 176. http://dx.doi.org/10.3390/ph13080176.
Der volle Inhalt der QuelleAnnotation:
Introduction: [68Ga]Ga-DO3A-VS-Cys40-Tuna-2 (previously published as [68Ga]Ga-DO3A-VS-Cys40-S01-GCG) has shown high-affinity specific binding to the glucagon receptor (GCGR) in vitro and in vivo in rats and non-human primates in our previous studies, confirming the suitability of the tracer for drug development applications in humans. The manufacturing process of [68Ga]Ga-DO3A-VS-Cys40-Tuna-2 was automated for clinical use to meet the radiation safety and good manufacturing practice (GMP) requirements. Methods: The automated synthesis platform (Modular-Lab PharmTrace, Eckert & Ziegler, Eurotope, Germany), disposable cassettes for 68Ga-labeling, and pharmaceutical-grade 68Ge/68Ga generator (GalliaPharm®) used in the study were purchased from Eckert & Ziegler. The parameters such as time, temperature, precursor concentration, radical scavenger, buffer concentration, and pH, as well as product purification step, were investigated and optimized. Process optimization was conducted with regard to product quality and quantity, as well as process reproducibility. The active pharmaceutical ingredient starting material DO3A-VS-Cys40-Tuna-2 (GMP-grade) was provided by Sanofi Aventis. Results: The reproducible and GMP-compliant automated production of [68Ga]Ga-DO3A-VS-Cys40-Tuna-2 with on-line documentation was developed. The non-decay-corrected radiochemical yield was 45.2 ± 2.5% (n = 3, process validation) at the end of the synthesis with a labeling synthesis duration of 38 min and a quality controlincluding release procedure of 20 min. The radiochemical purity of the product was 98.9 ± 0.6% (n = 17) with the total amount of the peptide in the preparation of 48 ± 2 µg (n = 3, process validation). Radionuclidic purity, sterility, endotoxin content, residual solvent content, and sterile filter integrity tests met the acceptance criteria. The product was stable at ambient temperature for at least 2 h. Conclusion: The fully automated GMP-compliant manufacturing process was developed and thoroughly validated. The resulting [68Ga]Ga-DO3A-VS-Cys40-Tuna-2 was used in a clinical study for accurate quantification of GCGR occupancy by a dual anti-diabetic drug in vivo in humans.
10
Malthufah, Yeda Rachma Ayu, und Kusuma Scorpia Lestari. „Assisting Food Household Industries in Implementation of Good Manufacturing Practice (GMP) on Frozen Meat Kebab in Sidoarjo District“. Media Gizi Kesmas 12, Nr. 2 (30.11.2023): 878–85. http://dx.doi.org/10.20473/mgk.v12i2.2023.878-885.
Der volle Inhalt der QuelleAnnotation:
Background: Good Manufacturing Practice (GMP) is a reference that explains the procedures to produce processed food so that it is of high quality, safe, and suitable for public consumption. The Food Safety Facilitator's role is to help register the processed products of SME (Small Medium Enterprise) X to obtain an NIE( Nomor Izin Edar) number. Objectives: The SME assistance aims to improve the implementation of GMP so that it can meet the GMP level that meets the requirements of the Regulation of the Head of the Food and Drug Administration on Guidelines for Inspection of Processed Food Production Facilities. Methods: Initial observations were made with a form based on the standards of the Food and Drug Administration to determine the score and value of SME X, then mentoring and training were carried out to correct GMP non-conformities. Results: The first observation of SME X showed that there were aspects that did not comply with the GMP requirements. With several non-conformities obtained, SME X received a grade of D or very poor, so it needs improvement to get an NIE number from BPOM. The results of the final inspection indicated an improvement in the score from D (very poor) to B (good) so that SME X could obtain the NIE number. Conclusions: Assistance and training to SMEs contributed to the improvement of SMEs' GMP implementation scores so that SME X was able to obtain a distribution license number for its food products
Dissertationen zum Thema "Production clinique grade GMP"
1
Kouhil, Menasria Naziha. „Islet Cell Purification Systems : Integration of Novel Repurposed GMP Closed-System Technologies from Evaluation to Patent Implementation“. Electronic Thesis or Diss., Université de Lille (2022-....), 2024. http://www.theses.fr/2024ULILS083.
Der volle Inhalt der QuelleAnnotation:
L'optimisation de la purification des cellules d'îlots est essentielle pour faire progresser les thérapies cellulaires ciblant le diabète de type 1, nécessitant l'intégration de technologies innovantes, conformes aux normes GMP, afin de renforcer l'efficacité des processus, l'automatisation et l'évolutivité. Cette thèse analyse deux technologies majeures employées dans la purification des îlots. La première étude examine l'impact d'un nouveau système de refroidissement sur le processus de purification des cellules d'îlots. Ce système permet un contrôle précis de la température durant la purification par gradient de densité grâce à un refroidissement sous pression, stabilisant efficacement la température tout en préservant la stérilité de l'environnement de salle blanche GMP. Comme solution rentable et peu invasive, ce système de refroidissement présente également des applications potentielles pour d'autres équipements de thérapie cellulaire, dont la majorité est dépourvue d'option de refroidissement. Le principal axe de cette thèse porte sur l’adaptation du système Sepax C Pro - Sefia, une technologie en circuit fermé initialement conçue pour le traitement des cellules souches hématopoïétiques, à la purification des cellules d'îlots humains. Avec le retrait progressif du système Cobe 2991 en Europe d'ici 2025 et mondialement d'ici 2031, la plateforme Sepax C Pro - Sefia constitue une alternative automatisée et conforme aux normes GMP. Elle intègre l’automatisation des étapes critiques du processus de purification des îlots, réduit la manipulation manuelle et améliore la reproductibilité des processus, en s'imposant comme une solution innovante pour les applications cliniques et de recherche en transplantation d'îlots. À la suite de ces avancées, un brevet intitulé « Systèmes et Méthodes pour le Traitement des Tissus » a été déposé pour protéger la méthode innovante développée pour le système reconverti Sepax C Pro - Sefia, assurant ainsi la sécurisation de la propriété intellectuelle et facilitant son application future en milieu clinique. Grâce à l'intégration de ces innovations technologiques, y compris une méthode brevetée pour le traitement des tissus, cette thèse propose un cadre exhaustif pour le remplacement du système Cobe 2991, garantissant la continuité de l'isolement clinique des îlots et contribuant à des thérapies plus efficaces pour les patients atteints de diabète de type 1 (allogreffes), ainsi que pour ceux souffrant de pathologies pancréatiques (autogreffes)The optimization of islet cell purification is crucial for advancing cell-based therapies for type 1 diabetes, requiring innovative, GMP-compliant technologies to improve process efficiency, automation, and scalability. This thesis evaluates two key technologies used in islet purification. The first study evaluates the impact of a novel cooling system on the islet cell purification process. This system ensures precise temperature control during density gradient purification by providing pressurized cooling, effectively stabilizing the temperature while maintains the sterility of the GMP cleanroom environment. As a cost-effective and minimally invasive solution, this cooling system holds promises to cool another cell therapy equipment the majority of which offer no cooling option.The core focus of My thesis is the repurposing of the Sepax 2C Pro- Sefia system, a closed-system technology originally developed for hematopoietic stem cell processing, for human islet cell purification. With the Cobe 2991 system being phased out in Europe by 2025 and globally by 2031, the Sepax 2 - Sefia platform offers a fully automated, GMP-compliant alternative. It automates key steps in the islet purification process, reduces manual handling, and improves process reproducibility, making it a ground-breaking solution for both clinical and research applications in islet transplantation. Building on the findings a patent: “Systems and Methods for Tissue Processing,” was filed to protect the novel approach developed for the repurposed Sepax 2 - Sefia system ensuring the intellectual property is secured and facilitating the future application of this system in clinical settings. Through the integration of these technological advancements, including a patented method for tissue processing, this thesis provides a comprehensive framework to replace the Cobe 2991 system, ensuring the continuity of clinical islet isolation and contributing to more effective therapies for patients with type1 diabetes (allografts) but also patients with pancreatic pathologies (autografts)
2
Laroye, Caroline. „Le cordon ombilical : une source alternative de cellules souches/stromales mésenchymateuses dans le traitement du choc septique ?“ Thesis, Université de Lorraine, 2017. http://www.theses.fr/2017LORR0279.
Der volle Inhalt der QuelleAnnotation:
Le choc septique est actuellement la dixième cause de mortalité à travers le monde à égalité avec les infarctus du myocarde. Sa physiopathologie extrêmement complexe, entrelaçant un état pro-inflammatoire et anti-inflammatoire, rend caduque l’action des thérapeutiques conventionnelles. En ce sens, les recherches s’orientent vers les thérapeutiques innovantes et notamment les cellules souches/stromales mésenchymateuses (CSM). En effet, les études murines ont mis en évidence que les CSM étaient en mesure, notamment par leurs actions paracrines, d’améliorer la survie, la défaillance d’organes mais également la bactériémie de souris soumises à un choc septique. Cependant, les propriétés des CSM varient en fonction du tissu dont elles sont issues et particulièrement selon qu’elles proviennent de tissus fœtaux (cordon ombilical, placenta, liquide amniotique) ou adultes (moelle osseuse, tissu adipeux...). Ainsi, notre premier objectif a été de comparer, dans un modèle murin de choc septique, l’action des CSM issues de la moelle osseuse (MO) à celle des CSM issues de la gelée de Wharton (GW) du cordon ombilical. Cette étude murine a permis de mettre en évidence une action quelque peu différente, entre les CSM-GW et les CSM-MO, sur la physiopathologie du choc septique sans que pour autant, l’une des deux sources de CSM, ne se dégage significativement de l’autre en termes d’efficacité. Cependant, en raison de leur importante capacité de prolifération et de l’accessibilité du tissu source, les CSM-GW apparaissent comme étant nettement plus avantageuses que les CSM-MO. En conséquence, notre deuxième objectif a été d’évaluer l’action des CSM-GW dans un modèle porcin de péritonite afin de se rapprocher un peu plus près de la clinique humaine. Cette étude, menée en double aveugle et en présence continue d’un médecin réanimateur expérimenté, a permis de mettre en évidence que les CSM-GW, produites en grade clinique et utilisées juste après décongélation, étaient en mesure d’améliorer la survie, les paramètres hémodynamiques ainsi que les défaillances d’organes, selon un mécanisme d’action différent de celui rapporté par les études murinesSeptic shock, equal to the myocardial infraction, is currently the tenth cause of death in the world. The pathophysiological complexity of this syndrome, with a simultaneous pro and anti- inflammatory state, results in the failure of conventional treatments. In this sense, research is focusing on innovative therapeutics agent, including mesenchymal stem cells (MSC). Indeed, murine studies of septic shock showed that MSC improve organ injuries, bacteremia and survival by notably a paracrine mechanism. However, MSC properties vary according to the source tissue, especially if they are derived from a fetal tissue (Wharton’s jelly (WJ), placenta amniotic fluid) or an adult tissue (bone marrow (BM), adipose tissue...). Our first objective was to compare, in a septic shock murine model, the effect of BM-MSC with that of WJ-MSC. Although some differences were observed, the same efficiency was demonstrated between these two sources. However, WJ-MSC present large advantages in comparison to BM-MSC due to their important proliferation capacities and potential quantities of umbilical cord donation. Consequently, our second objective was to investigate the effect of WJ-MSC administration in a relevant pig model of peritonitis in order to better mimic a clinical approach in humans. This study, conducted in double-blind and in presence of an experimented intensivist, showed that WJ-MSC produced in clinical grade and used immediately after thawing, improve survival, hemodynamic parameters and organ injuries by another action than that described in murine studies
3
Rothé, Lamia. „Reconstitution immunitaire et immunothérapie adoptive anti-virales après allogreffe de cellules souches hématopoiétiques“. Thesis, Nancy 1, 2010. http://www.theses.fr/2010NAN10073/document.
Der volle Inhalt der QuelleAnnotation:
L’allogreffe de cellules souches hématopoïétiques (CSH) est un traitement efficace des Hémopathies malignes. Cependant, les complications des allogreffes parmi lesquelles les infections virales sont associées parfois à une morbidité et une mortalité importantes. Ces infections surviennent en l’absence de reconstitution immunitaire. Un monitoring régulier de la charge virale des principaux agents infectieux impliqués est réalisé mais amène parfois à la mise en oeuvre abusive de traitements anti-viraux qui ne sont pas dénués de toxicité.Dans ce travail, nous proposons d’associer à ce monitoring un suivi régulier de la reconstitution immunitaire spécifique afin de cibler parmi les patients présentant une réactivation ceux qui nécessitent un traitement curatif de ceux qui pourront maîtriser l’infection par leur système immunitaire. Nous illustrons ce propos avec le virus d’Epstein Barr (EBV) et avons en cours une étude sur l’Adénovirus (ADV).Dans certains cas parfaitement ciblés, les traitements anti-viraux s’avèrent inefficaces. C’est pourquoi dans ce travail, nous présentons la mise au point d’une technique de grade clinique de production de lymphocytes T cytotoxiques anti-ADV (CTL anti-ADV) en condition GMP (Good Manufacturing Practice), grâce au système CliniMACS et au Cytokine Capture System de Miltenyi, afin de proposer une immunothérapie adoptive.Nous décrivons par la suite trois expériences cliniques de traitement compassionnel d’une infection ADV post-allogreffe de CSH. Enfin, nous présentons les résultats préliminaires de la production de CTL bispécifique anti-ADV et CMVHematopoietic stem cells Transplantation (HSCT) is a well recognized strategy for treatment of haematological malignancies. However, HSCT complications among which the viral infections a reassociated with high morbidity and mortality. These infections arise in the absence of immune reconstitution. Monitoring of viral reactivations after allogeneic HSCT is necessary, to identify patients at risk of viral infections, but not sufficient, as patients may be abusively treated. In this work we propose to combine viral DNA load assessment with specific immune monitoring to target patients who need to be treated. We report a retrospective study investigating EBV infection and EBV-specific immune recovery using the functional IFN Elispot assay in 40 allogeneic HSCT patients. We initiated a similar study with ADV which is pending. However, although patients are correctly targeted, anti-viral treatment is sometimes not effective. We present a study on the development of a complete clinical grade generation of Human anti-Adenovirus cytotoxic T cells in GMP (Good Manufacturing Practice) conditions, thanks to the system CliniMACS and the Cytokine Capture System, to propose an adoptive immunotherapy to the recipient.We describe afterwards three clinical experiments of treatment of an ADV infection after HSCT.Finally, we present the preliminary results of the anti-ADV and -CMV bi-specific CTL production
Buchteile zum Thema "Production clinique grade GMP"
1
Andriolo, Gabriella, Elena Provasi, Andrea Brambilla, Viviana Lo Cicero, Sabrina Soncin, Lucio Barile, Lucia Turchetto und Marina Radrizzani. „GMP-Grade Methods for Cardiac Progenitor Cells: Cell Bank Production and Quality Control“. In Methods in Molecular Biology. New York, NY: Springer US, 2020. http://dx.doi.org/10.1007/7651_2020_286.
Der volle Inhalt der QuelleKonferenzberichte zum Thema "Production clinique grade GMP"
1
Al-Sulaiti, Asma Mohammed, Moza Al- Khulaifi, Sara Al-Khawaga, Zohreh Calderone, Bella Guerrouahen und Chiara Cugno. „Adipose Tissue Derived-Mesenchymal Stromal Cell: Setting the ground for Clinical Grade Production at Sidra's GMP Facility“. In Qatar Foundation Annual Research Conference Proceedings. Hamad bin Khalifa University Press (HBKU Press), 2018. http://dx.doi.org/10.5339/qfarc.2018.hbpd615.
Der volle Inhalt der Quelle
2
Cugno, Chiara, Moza Alkhualifi, Asma Al-Sulaiti, Bella Guerrouahen, Sara Al-Khawaga und Zohreh Calderone. „Foreskin DerivedMesenchymal Stromal Cell FSKMSC: Setting the ground for the Clinical Grade Production of MSC at Sidra's GMP Facility“. In Qatar Foundation Annual Research Conference Proceedings. Hamad bin Khalifa University Press (HBKU Press), 2018. http://dx.doi.org/10.5339/qfarc.2018.hbpd736.
Der volle Inhalt der Quelle
3
Adamson, Lars, Dhifaf Sarhan, Bhavesh Choudhary, Jeroen Melief, Maria Nyström, Ulrika Edbäck, Renee Vermeij et al. „Abstract B071: Enhanced IL-12 production and T cell stimulation ability by dendritic cells matured in presence of GMP-grade Toll-like receptor ligands and IFN-γ“. In Abstracts: CRI-CIMT-EATI-AACR Inaugural International Cancer Immunotherapy Conference: Translating Science into Survival; September 16-19, 2015; New York, NY. American Association for Cancer Research, 2016. http://dx.doi.org/10.1158/2326-6074.cricimteatiaacr15-b071.
Der volle Inhalt der Quelle