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Journal articles on the topic 'Bio-Safety'

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Published: 1 June 2024

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1

Ahmad, K. "Molecular farming: strategies, expression systems and bio-safety considerations." Czech Journal of Genetics and Plant Breeding 50, No. 1 (February 13, 2014): 1–10. http://dx.doi.org/10.17221/187/2013-cjgpb.

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Molecular farming is an experimental application of biotechnology that involves the genetic modification of crops for the production of proteins and chemicals for medicinal and commercial purposes. The vast majority in the developing world cannot afford the high cost of therapeutics produced by existing methods. We need to produce not only new therapeutics but also cheaper versions of the existing ones. Molecular farming could offer a viable option for this growing need for biopharmaceuticals. Plant made therapeutics are cheaper, safer, can be abundantly produced and easily stored. Here, strategies and approaches utilized in plant molecular farming are discussed. Furthermore, the bio-safety considerations related to this emerging field are also discussed.

2

Roberts, Peter. "Virus safety in bio products." Journal of Chemical Technology AND Biotechnology 59, no. 1 (January 1994): 110–11. http://dx.doi.org/10.1002/jctb.280590126.

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3

Ntumba Kabitambishi Georgette, Angelique. "Assessment of Bio-Safety, Bio-Security and Microbial Ecology of Bovine Meat at the Masina Slaughterhouse." International Journal of Science and Research (IJSR) 13, no. 1 (January 5, 2024): 1357–62. http://dx.doi.org/10.21275/sr24122213935.

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4

Kumar, Kotta Kranthi. "Bio Safety Regulatory Agencies in India." Asian Journal of Pharmacy and Pharmacology 4, no. 1 (2018): 13–16. http://dx.doi.org/10.31024/ajpp.2018.4.1.3.

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Catalán, Julia, and Hannu Norppa. "Safety Aspects of Bio-Based Nanomaterials." Bioengineering 4, no. 4 (December 1, 2017): 94. http://dx.doi.org/10.3390/bioengineering4040094.

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6

(Wayne) Wang, Yun F. "Ebola bio-safety and laboratory testing." Journal of Microbiology, Immunology and Infection 48, no. 2 (April 2015): S17. http://dx.doi.org/10.1016/j.jmii.2015.02.161.

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7

Raspor, Peter. "Bio-markers: traceability in food safety issues." Acta Biochimica Polonica 52, no. 3 (September 30, 2005): 659–64. http://dx.doi.org/10.18388/abp.2005_3427.

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Research and practice are focusing on development, validation and harmonization of technologies and methodologies to ensure complete traceability process throughout the food chain. The main goals are: scale-up, implementation and validation of methods in whole food chains, assurance of authenticity, validity of labelling and application of HACCP (hazard analysis and critical control point) to the entire food chain. The current review is to sum the scientific and technological basis for ensuring complete traceability. Tracing and tracking (traceability) of foods are complex processes due to the (bio)markers, technical solutions and different circumstances in different technologies which produces various foods (processed, semi-processed, or raw). Since the food is produced for human or animal consumption we need suitable markers to be stable and traceable all along the production chain. Specific biomarkers can have a function in technology and in nutrition. Such approach would make this development faster and more comprehensive and would make possible that food effect could be monitored with same set of biomarkers in consumer. This would help to develop and implement food safety standards that would be based on real physiological function of particular food component.

8

Sauer, John-Michael, Elizabeth G. Walker, and Amy C. Porter. "The Predictive Safety Testing Consortium: safety bio-markers, collaboration, and qualification." Journal of Medicines Development Sciences 1, no. 1 (November 17, 2016): 34. http://dx.doi.org/10.18063/jmds.v1i1.116.

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The Predictive Safety Testing Consortium (PSTC) is one of nine consortia comprising the Critical Path Institute (C-Path), a non-profit organisation launched in 2005 and dedicated to playing the role of a catalyst in the development of new approaches that advance medical innovation and regulatory science. C-Path achieves this by lead-ing teams that share data, knowledge and expertise resulting in sound, consensus-based science. PSTC is a unique, public-private partnership that brings pharmaceutical companies together to share and validate safety testing methods under the advisement of worldwide regulatory agencies, including the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA). The eighteen corporate members of PSTC share a common goal: to find improved safety testing methods and approaches utilizing fluid-based safety biomarkers which accurately predict drug-induced tissue injury. Specifically, the primary goal of PSTC is the qualification of novel translational safety biomarkers for use in early clinical trials in order to ena-ble safer investigations and development of new drug candidates. This manuscript describes the critical importance of improved safety biomarkers to the drug development process and the present state of the biomarker qualification process with regulatory agencies. In addition, the work that the PSTC and its collaborative partners have done and con-tinue to do to identify and qualify more selective and specific safety biomarkers is highlighted. Finally, successes in-cluding the recently adopted regulatory Letter of Support and ongoing efforts to better define the regulatory qualifica-tion process and an integrated translational safety strategy are also discussed.

9

Sauer, John-Michael, Elizabeth G. Walker, and Amy C. Porter. "The Predictive Safety Testing Consortium: safety bio-markers, collaboration, and qualification." Journal of Medicines Development Sciences 1, no. 1 (November 17, 2016): 34. http://dx.doi.org/10.18063/jmds.2015.01.007.

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Abstract:

The Predictive Safety Testing Consortium (PSTC) is one of nine consortia comprising the Critical Path Institute (C-Path), a non-profit organisation launched in 2005 and dedicated to playing the role of a catalyst in the development of new approaches that advance medical innovation and regulatory science. C-Path achieves this by lead-ing teams that share data, knowledge and expertise resulting in sound, consensus-based science. PSTC is a unique, public-private partnership that brings pharmaceutical companies together to share and validate safety testing methods under the advisement of worldwide regulatory agencies, including the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA). The eighteen corporate members of PSTC share a common goal: to find improved safety testing methods and approaches utilizing fluid-based safety biomarkers which accurately predict drug-induced tissue injury. Specifically, the primary goal of PSTC is the qualification of novel translational safety biomarkers for use in early clinical trials in order to ena-ble safer investigations and development of new drug candidates. This manuscript describes the critical importance of improved safety biomarkers to the drug development process and the present state of the biomarker qualification process with regulatory agencies. In addition, the work that the PSTC and its collaborative partners have done and con-tinue to do to identify and qualify more selective and specific safety biomarkers is highlighted. Finally, successes in-cluding the recently adopted regulatory Letter of Support and ongoing efforts to better define the regulatory qualifica-tion process and an integrated translational safety strategy are also discussed.

10

AHAMMED, TAMSEL, SABRINA ZAMAN, MD JUBAIR HASSAN, and SHIREEN NIGAR. "EVALUATION OF BIOSAFETY ASSESSMENT AMONG LABORATORY STAFF IN SELECTED HOSPITALS AND DIAGNOSTIC CENTERS AT JASHORE DISTRICT IN BANGLADESH." Asian Journal of Microbiology, Biotechnology & Environmental Sciences 25, no. 02 (2023): 190–205. http://dx.doi.org/10.53550/ajmbes.2023.v25i02.003.

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–Medical laboratories staff are exposed to professional bio-hazards on a regular basis if proper protective standards are not put in place, both their health and safety may be at danger. The initiative of this study is based on the articulation of the knowledge, attitude and practice regarding biological hazards among the laboratory staffs. Innumerable accidents happen due to lack of sufficient information about laboratory safety procedures, a callous attitude, and incorrect administration in the laboratory. This study was carried out among the staff of selected Hospitals and Diagnostic Centers at Jashore region to evaluate the KPA of laboratory bio-safety. In both approaches and manner, a descriptive cross-sectional survey was conducted among 192 laboratory staff from 52 Hospital and Diagnostic Centers. Data was gathered from a structured self-observed questionnaire and checklist, which were created and evaluated based on existing research and guidelines on universal work considerations. A total of 192 staffs who consented were included in the study. Where 150 (78.1%) male and 42(19.9%) female. 116 (64.4%) were 20-30 years age group, 49 (25.5%) were over 10 years of experience and 129(67.2%) married respondents. In the study 166 (86.5%) respondents work more than 8 hours in the lab and 59 (30.7%) were overweight. 66(34.4%) of staff have good knowledge on bio-safety, good attitude and practice 46 (24%) and 25(13%) on bio-safety respectively. Within the demographic information observed, only the working hour displayed significant (p=0.000) influence on the bio-safety knowledge. Age of the worker (p=0.000) and experience (p=0.001) had great influence on bio-safety attitude. Among the participants 104 (54.2%) received formal safety training and 155(80.7%) aware about universal work precaution. 145 (75.5%) never washed hands before putting gloves and 70(36.5%) always used PPE. Average (Mean ± SD) of laboratory staff knowledge, practice and attitude 71.72±10.40, 63.21±12.16 and 70.68±14.20 respectively. Overall, the data suggest that good knowledge and attitude to bio-safety practices between lab staff was indicated and their practices need to be more improved. Arrangement of training programs, proper monitoring and sticking to legislation must be implemented by the governance body to rise conversance of the laboratories staff about strict laboratory techniques and biohazards.

11

Gonin, P., C. J. Buchholz, M. Pallardy, and M. Mezzina. "Gene therapy bio-safety: scientific and regulatory issues." Gene Therapy 12, S1 (October 2005): S146—S152. http://dx.doi.org/10.1038/sj.gt.3302629.

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12

Ligthelm, T. "High Security Bio-Safety Isolation under Operational Circumstances." Prehospital and Disaster Medicine 20, S1 (April 2005): 45–46. http://dx.doi.org/10.1017/s1049023x00012905.

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13

ter Haar, Gail. "Safety and bio-effects of ultrasound contrast agents." Medical & Biological Engineering & Computing 47, no. 8 (July 14, 2009): 893–900. http://dx.doi.org/10.1007/s11517-009-0507-3.

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14

Jeff Johnson, special to C&EN. "Safety board releases report on Bio-Lab accident." C&EN Global Enterprise 101, no. 14 (May 1, 2023): 10. http://dx.doi.org/10.1021/cen-10114-polcon2.

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15

Poejiani, Soeyati. "Penggunaan Plastik Polypropilen sebagai Pengganti Safety Box di Laboratorium BIO SAFETY LEVEL II." Indonesian Journal of Laboratory, no. 3 (November 5, 2023): 54. http://dx.doi.org/10.22146/ijl.v0i3.88120.

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Plastik Polypropilen merupakan bahan plastik yang mempunyai sifat tahan panas sehingga mampu mencegah terjadinya reaksi kimia. Plastik polypropilen ini bisa digunakan sebagai pengganti safety box karena murah harganya dan mudah di dapat. Tujuan penelitian ini mengetahui plastik polypropilen dapat digunakan sebagai wadah pembuangan sementara limbah Corona Virus Disease 2019 (Covid-19) selama bekerja di laboratorium Biosafety Level II (BSL II). Penelitian ini merupakan eksperimental laboratoris dengan menggunakan sampel diduga covid-19 dengan metode pre destruksi dan post destruksi. Pengamatan dilakukan ada tidaknya gen target dengan menggunakan Real Time Polymerase Reaction (Rt-PCR). Berdasarkan penelitian ini penggunaan plastik polypropilen untuk wadah sementara selama bekerja di BSL II pada proses pre destruksi ditemukannya gen target atau positif. Setelah dilakukan post destruksi tidak ditemukan adanya gen target atau negatif. Data pengujian dianalisis menggunakan Bio-Rad CFX

16

Ranathunga, Nethma Samadhi, Kaushalya Nadeeshani Wijayasekara, and Edirisinghe Dewage Nalaka Sandun Abeyrathne. "Application of bio-preservation to enhance food safety: A review." Korean Journal of Food Preservation 30, no. 2 (April 2023): 179–89. http://dx.doi.org/10.11002/kjfp.2023.30.2.179.

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Consumers and industry experts frequently have negative perceptions of most chemical preservatives. Although most people concede that they cannot resolve global food waste issues without preservatives, they prefer products without chemical preservatives. Numerous emerging technologies is now surpassing conventional methods for mitigating microbial food deterioration in response to consumer demand and fundamental health and safety considerations, including biological antimicrobial systems such as using food-grade microorganisms and their metabolites primarily originating from microorganisms, plants, and animals. Microbial compounds, including bacteriocins, bacteriophages, and anti-fungal agents, plant extracts such as flavonoids and essential oils; and animal-originated compounds, such as lysozyme, chitosan, and lactoferrin, are considered some of the major bio-preservatives. These natural compounds can be used alone or with other preservatives to improve food safety. Hence, the use of microbes or their metabolic byproducts to extend the shelf life of foods while maintaining safety standards is known as bio-preservation. To manufacture and consume foods in a safe condition, this review primarily aims to broaden knowledge amongst industry professionals and consumers regarding bio-preservation techniques, bio-preservatives, their classifications, and distinctive mechanisms to enhance food safety.

17

An, G., Dong Ying Ju, Pei Bian, T. Kumazawa, and M. Okasabe. "Bio-Medicine Coating on Surface of Magnetic Nanoparticles and its Safety Evaluation." Materials Science Forum 675-677 (February 2011): 303–6. http://dx.doi.org/10.4028/www.scientific.net/msf.675-677.303.

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The composite magnetic nanoparticles of coated SiO nano film with about 8 nm size can be dispersed in various liquid media, widely known as magnetic fluids or ferrofluids with both magnetic and liquid properties. In this paper, a bio-medicine coating technology on surface of magnetic nanoparticles and the optimum fabrication condition and the magnetism of composed bio-nanoparticles are investigated. Through observation of micro-structure of the bio-nanopaticles on coating surface, and evaluation of magnetic property and safety to apply to biomaterials, we know the bio-medicine coated on surface of magnetic nanoparticles is suitable of bio-solutions into surface of biomaterials.

18

Kobayashi, Takako, Wataru Miyazaki, Kazukiyo Yamamoto, Yuji Miura, and Takeo Kondo. "CONCEPTUALIZING THE BIO-SAFETY LEVEL 4 LOCATION AND MANAGEMENT." International Journal of Life Science and Medical Research 2, no. 4 (December 15, 2012): 101–7. http://dx.doi.org/10.5963/lsmr0204008.

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19

Y. C. Kong, Jack, Karl Nitsch, and Jenna Diana Bridgewater. "Viral-Genetic Safety Engineering of Apply bio-EMF Science." American Journal of Medical Sciences and Medicine 10, no. 2 (May 27, 2022): 44–46. http://dx.doi.org/10.12691/ajmsm-10-2-2.

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20

Kazyrytski, P. A. "Actual problems of safety of earth bio-pathogenic zones." Вестник Белорусско-Российского университета, no. 3 (2010): 164–73. http://dx.doi.org/10.53078/20778481_2010_3_164.

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21

Swaminathan, M. S. "Bio-diversity: an effective safety net against environmental pollution." Environmental Pollution 126, no. 3 (December 2003): 287–91. http://dx.doi.org/10.1016/s0269-7491(03)00241-0.

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22

Stacey, Glyn N., and Heather J. Sheeley. "Have bio-safety issues in cell culture been overlooked?" Journal of Chemical Technology AND Biotechnology 61, no. 2 (October 1994): 95–96. http://dx.doi.org/10.1002/jctb.280610202.

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23

Kazama, Tomoe, Katsuyoshi Ando, Nobuhiro Ueno, Mikihiro Fujiya, Takahiro Ito, Atsuo Maemoto, Keisuke Ishigami, Masanori Nojima, and Hiroshi Nakase. "Long-term effectiveness and safety of infliximab-biosimilar: A multicenter Phoenix retrospective cohort study." PLOS ONE 18, no. 9 (September 12, 2023): e0288393. http://dx.doi.org/10.1371/journal.pone.0288393.

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Background Infliximab (IFX) effectively treats patients with inflammatory bowel disease (IBD). IFX-biosimilar (IFX-BS) has the same amino acid sequence as that of the IFX originator, and its increasing use is expected to reduce national healthcare costs. Long-term efficacy and safety of IFX-BS in patients with Crohn’s disease (CD) and ulcerative colitis (UC) have not been completely investigated. Methods We conducted a retrospective, multicenter observational study of patients with IBD who received IFX-BS treatment at three hospitals between October 2016 and April 2022. Clinical data were collected from electronic medical records and evaluated for achieving clinical remission (CR) using Crohn’s disease activity index (CDAI) and partial Mayo (pMayo) score, persistency of long-term IFX-BS administration, and clinical response rate in the bio-naïve and bio-failure groups. Results A total of 117 patients with IBD (90 CD and 27 UC) were included. The study findings indicated that both bio-naïve and bio-failure groups of patients with UC showed similar effectiveness of IFX-BS. The treatment persistence rate in patients with CD was significantly higher in the bio-naïve (P = 0.042) and switch (P = 0.010) groups than in the bio-failure group. In the former two groups, the treatment persistence rate was high at two years after administration (more than 80%). In patients with UC, the findings indicated higher treatment persistence rate in the switch group than in the bio-naïve group. Univariable and multivariable analyses for treatment persistence rate showed that the albumin level at the initial IFX-BS administration and groups (bio-naïve, bio-failure and switch) were effective factors for patients with CD. Adverse events were reported in 18 patients (15.4%). Conclusion The present study demonstrates the long-term effectiveness and safety of IFX-BS. In addition to the favorable remission induction in the bio-naïve and bio-failure groups, we demonstrated remission maintenance and treatment persistence rates beyond two years. Albumin level and groups were associated with better treatment persistence in patients with CD.

24

Wang, Xinghua, Yukun Yang, Hening Zhang, and Ju Liu. "Safety Assessment and Comparison of Sodium Selenite and Bioselenium Obtained from Yeast in Mice." BioMed Research International 2017 (2017): 1–8. http://dx.doi.org/10.1155/2017/3980972.

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Detailed safety assessment of sodium selenite and bioselenium (bio-Se) was conducted and the results were compared and discussed for the purpose of assessing safety of bio-Se for use in food applications. In this work, acute toxicity studies, micronucleus test, and sperm aberration study in mice, 30-day feeding test of mice, were conducted to evaluate the toxicity of bio-Se obtained from yeast with different fermentation time (transformative time: one month, three months, and six months), and the results were compared with that of inorganic Se (sodium selenite). LD50of sodium selenite was calculated to be 21.17 mg/kg. LD50of bio-Se obtained from yeast with different fermentation time was calculated to be 740.2 mg/kg, 915.3 mg/kg, and 1179.0 mg/kg, respectively. In the genotoxicity test, bio-Se did not show cytotoxicity and genotoxicity of mice while sodium selenite at all dose groups was significantly different from the negative group. In the 30-day subchronic oral toxicity study, sodium selenite may slow down the growth of the mice and lead to organic damage to some extent. Bio-Se had facilitated effect towards the body weight of the mice and had no significant effect on the shape and function of the important organs of the mice.

25

Song, Tingyu, Sheng Qian, Tiantong Lan, Yuzhu Wu, Jingsheng Liu, and Hao Zhang. "Recent Advances in Bio-Based Smart Active Packaging Materials." Foods 11, no. 15 (July 26, 2022): 2228. http://dx.doi.org/10.3390/foods11152228.

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The shortage of oil resources is currently a global problem. The use of renewable resources instead of non-renewable ones has become a hot topic of research in the eyes of scientists. In the food industry, there is a lot of interest in bio-based smart active packaging that meets the concept of sustainability and ensures safety. The packaging has antibacterial and antioxidant properties that extend the shelf life of food. Its ability to monitor the freshness of food in real time is also beneficial to consumers’ judgement of food safety. This paper summarises the main raw materials for the preparation of bio-based smart active packaging, including proteins, polysaccharides and composite materials. The current status of the preparation method of bio-based smart active packaging and its application in food preservation is summarised. The future development trend in the field of food packaging is foreseen, so as to provide a reference for the improvement of bio-based smart active packaging materials.

26

Ungureanu, Camelia, Grațiela Tihan, Roxana Zgârian, and Georgica Pandelea (Voicu). "Bio-Coatings for Preservation of Fresh Fruits and Vegetables." Coatings 13, no. 8 (August 13, 2023): 1420. http://dx.doi.org/10.3390/coatings13081420.

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In response to increasing concerns over food waste and safety, and the environmental impacts of traditional conservation methods, this review aims to explore the potential of bio-coatings in preserving the freshness of fruits and vegetables. Our primary objective is to provide a comprehensive analysis of recent advancements in bio-coating technologies, detailing their benefits in terms of enhancing food safety, prolonging shelf life, and reducing waste. This paper delves into various forms of bio-coatings, their applications, and their effectiveness in maintaining post-harvest quality. We further elucidate the underlying mechanisms that govern their preservation efficacy. This review is intended for researchers, industry professionals, and policy makers who are interested in sustainable preservation alternatives and their implications for food security and environmental sustainability. By the end of this review, the audience will gain a thorough understanding of the current state of bio-coating technology and its prospects in the food preservation industry.

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Jayaraman, Venkatachalam, Ganesan Bhavesh, Shanmugavel Chinnathambi, Singaravelu Ganesan, and Prakasarao Aruna. "Synthesis and characterization of hafnium oxide nanoparticles for bio-safety." Materials Express 4, no. 5 (October 1, 2014): 375–83. http://dx.doi.org/10.1166/mex.2014.1190.

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28

Fábos, Viktória, Gabriella Koczó, Hasan Mehdi, László Boda, and István T. Horváth. "Bio-oxygenates and the peroxide number: a safety issue alert." Energy & Environmental Science 2, no. 7 (2009): 767. http://dx.doi.org/10.1039/b900229b.

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29

D’Haens, G., M. Beaton, P. Bossuyt, I. Dotan, B. Sands, K. Sugimoto, E. Neimark, et al. "P544 Patients with moderate to severe Crohn’s disease with and without prior biologic failure demonstrated improved clinical outcomes with risankizumab: Results from phase 3 induction and maintenance trials." Journal of Crohn's and Colitis 16, Supplement_1 (January 1, 2022): i491. http://dx.doi.org/10.1093/ecco-jcc/jjab232.671.

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Abstract Background Risankizumab (RZB), a selective interleukin-23 inhibitor, demonstrated superior efficacy over placebo (PBO) as induction and maintenance therapy in patients with moderate to severe Crohn’s disease (CD). Here we compared the efficacy and safety of RZB in inducing and maintaining clinical remission and clinical response in patients with CD who demonstrated intolerance and/or inadequate response (IR) to biologic therapies (with prior bio-failure) versus those who demonstrated IR to conventional therapies only (without prior bio-failure). Methods This subgroup analysis included pooled induction data from patients randomized to receive intravenous (IV) RZB 600mg (N=527) or placebo (PBO) IV (N=362) every 4 weeks (wks) for 12wks in the ADVANCE+MOTIVATE studies, and maintenance data from IV RZB responders who were randomized to subcutaneous (SC) RZB 360mg (N=141) or withdrawn from RZB to receive PBO SC (withdrawal [PBO SC], N=164) every 8wks for 52wks in FORTIFY. Clinical remission (per CDAI and per stool frequency [SF]/abdominal pain score [APS]), CDAI clinical response, enhanced SF/APS clinical response, and maintenance of clinical remission were evaluated in the overall population, and in subgroups with and without prior bio-failure, using non-responder imputation. Only descriptive statistics were used for the subpopulations (Endpoints are defined in Table footnotes). Safety was assessed throughout the studies. Results Approximately three-quarters of randomized patients included in the subgroup analyses had prior bio-failure (ADVANCE+MOTIVATE: 75.4%; FORTIFY: 73.8%). Among the subpopulations, numerically higher rates of clinical remission (CDAI and SF/APS), CDAI clinical response, and enhanced SF/APS clinical response were observed at the end of induction (wk12) among patients receiving RZB 600mg IV versus PBO IV (Figure); rates were numerically higher in the subpopulation without prior bio-failure than with prior bio-failure. FORTIFY Wk52 response rates for these endpoints, along with maintenance of clinical remission, were higher in the RZB 360mg SC arm compared to the withdrawal (PBO SC) arm in both subpopulations, with numerically higher rates observed for the subgroup without prior bio-failure (Figure). RZB maintenance treatment was well-tolerated and no new safety signals were observed. The safety profile of RZB has been reported previously.1,2 Conclusion Across the induction and maintenance studies, compared to PBO, RZB treatment led to greater clinical remission and clinical response in patients with CD independent of prior biologic experience. The subpopulation without prior bio-failure achieved higher rates of symptomatic remission.

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Mannix, Sally, Jessica Brewster, Anne M. Rentz, Andrew Lloyd, Regina Butler, and Peter J. Larson. "User Preference for 3 Hemophilia Factor Reconstitution Methods." Blood 104, no. 11 (November 16, 2004): 5302. http://dx.doi.org/10.1182/blood.v104.11.5302.5302.

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Abstract Introduction: Treatment of hemophilia includes the reconstitution of lyophilized FVIII concentrates with diluent followed by intravenous injection. Several reconstitution devices exist for infusion of concentrates. The Bio-Set® (Biodome, Issoire France) is a new needleless device for reconstituting a factor VIII concentrate, Kogenate® FS (Bayer Healthcare, Elkhart, IN). Objective: Comparison of preferences for reconstitution methods by hemophilia patients, caregivers to hemophilia patients, and care providers. Methods: A total of 35 hemophilia A patients who infuse themselves, 67 caregivers, and 59 infusion nurses were recruited following an IRB-approved protocol. Infusion method names were blinded to participants to prevent brand recognition. Reconstitution methods used in this study were Bio-Set®, a conventional 2 vial, transfer needle reconstitution method, and Baxject (Baxter Healthcare, Westlake Village CA). Participants viewed a video demonstrating the three methods, watched the interviewer demonstrate each method, and then practiced each method once. Each participant performed 1 timed round with each method and completed preference questionnaires about each method. The preference questionnaire was scored into domains for safety/worry and ease/confidence, in addition to a total preference score. Participants’ comments about the reconstitution methods were also recorded. Results: Participants preferred the Bio-Set® in terms of worry/safety, ease/confidence, and overall preference. These results were consistent across participant group. Participants agreed on their preferences for the Bio-Set® in terms of safety from needlesticks, amount of waste produced, and convenience for traveling (all p<0.0001). Analysis of the qualitative data indicated that exposure to needles and product contamination were issues commonly noted. Safety and complexity of instructions were also common issues for participants. Conclusions: Results of this study show that patients, caregivers, and nurse providers prefer the Bio-Set® reconstitution device over other methods for preparing factor concentrates for infusion.

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Wei, S. C., W. C. Lin, C. H. Chang, C. H. Tu, I. C. Feng, M. J. Shieh, C. S. Chung, et al. "P425 Real-world evidence on effectiveness and safety of vedolizumab therapy for inflammatory bowel disease in Taiwan: Results from the TSIBD registry (VIOLET Study)." Journal of Crohn's and Colitis 15, Supplement_1 (May 1, 2021): S428—S430. http://dx.doi.org/10.1093/ecco-jcc/jjab076.549.

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Abstract Background GEMINI trials and real-world studies in Western population have demonstrated the effectiveness and safety of vedolizumab (VDZ) for IBD. However, long-term real-world evidence of VDZ in Asian populations remains limited. This study aimed to investigate the effectiveness and safety of VDZ in Taiwan CD and UC patients, and the IBD relapse after VDZ discontinuation. Methods Data were prospectively collected (January 2018-May 2020) from the Taiwan Society of IBD (TSIBD) registry, one of the largest real-world Asian IBD cohorts. Patients (>18 years old) receiving ≥1 dose of VDZ with up to a 1-year follow-up period were analyzed. Effectiveness at 6 month and 1 year including clinical response (CRS), clinical remission (CRM), steroid-free remission (SRM) and mucosal healing (MH);and safety outcome were analyzed descriptively. IBD relapse after VDZ treatment discontinuation was assessed since the reimbursement period in Taiwan is limited due to drug holiday required by government. Results A total of 274 patients (CD:127, UC:147) were included. At VDZ initiation, average [SD] age (year): 33.4 [14.6] in CD and 42.4 [14.3] in UC; median disease duration (years): 3.1 in CD and 3.9 in UC; 50.4% of CD and 70.7% of UC patients were biologics (bio)-naïve. Treatment effectiveness was analyzed (Figure 1-4). At 6 months, effectiveness in the CD bio-naïve group was significantly higher than the bio-exposed patients in CRS (67.4% vs 43.9%, p=0.047), CRM (62.8% vs 39.0%, p=0.025), and SRM (43.3% vs 4.3%, p=0.001), respectively. At 1 year, the CD bio-naïve group had higher CRS (82.1% vs 60.7%, p=0.026) than the bio-exposed group. There was no difference in effectiveness between bio-naïve and bio-exposed groups in UC at both 6 months and 1 year. Three patients (1.1%) reported serious infections (respiratory infection, intractable infection with underlying myelodysplastic syndrome and intestinal perforation due to endoscopy) and two (0.7%) had infusion-related reactions. No malignancies or hepatic injuries were reported. After limited treatment up to one year due to reimbursement, 58% (54/93) of patients had IBD relapse (CD: 27 [62.8%], UC: 27 [54%]). After cessation of VDZ, the mean [SD] time to IBD relapse was 5.5 [4.0] months in CD, and 5.8 [5.7] months for UC. Conclusion This study has shown the effectiveness and safety of VDZ therapy for Taiwan IBD patients. Better outcomes were observed in bio-naïve CD patients, whereas bio-naïve and bio-exposed UC patients have comparable outcomes. After a limited VDZ treatment duration, over one-half of patients had IBD relapse, with the majority occurring within 5 months of VDZ discontinuation. These data suggest that continued VDZ therapy would benefit the majority of IBD patients in Taiwan.

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Zhao, Ping, Min-Chao Liu, Thushara W. Madanayake, Chawla Reena, Min Zheng, Zhen-Feng Cheng, Yu-Min Huang, and Xia-Hong Wang. "Cationic porphyrin@SPION nanospheres as multifunctional anticancer therapeutics: magnetic targeting, photodynamic potential and bio-safety research." RSC Advances 6, no. 105 (2016): 103137–48. http://dx.doi.org/10.1039/c6ra19697g.

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Kurshin, Dmitiy A., Asiyat M. Abdullaeva, Irina V. Medvedeva, and Natalya D. Ryabukhina. "USAGE BIO-SOLUTION «REMEDION» FOR COMPLEX BIOREMEDIATION OF CASCADE BIO-PONDS POST-TREATMENT OF TREATMENT FACILITIES." Problems of veterinary sanitation, hygiene and ecology 1, no. 45 (2023): 77–83. http://dx.doi.org/10.36871/vet.san.hyg.ecol.202301011.

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This article is devoted to study of methodology of usage bio-solution «Remedion» for complex treatment of cascade bio-ponds post-treatment of central drainage systems treatment facilities. The justification of necessity of ecological treatment changes by the implementation of new technology of bioremediation is given. Usage of “Remedion” is ecologically efficient, cost-effective and has a practical value for providing the ecological safety and environmental protection.

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Reinisch, W., J. Tran, K. Patel, N. Borruel, G. Y. Melmed, L. Wegrzyn, G. Levy, D. Ilo, Y. Sanchez Gonzalez, and R. Panaccione. "P658 Comparative Efficacy and Safety of Upadacitinib Versus Tofacitinib as Induction Therapy in Patients With Moderately to Severely Active Ulcerative Colitis: A Matching-Adjusted Indirect Comparison." Journal of Crohn's and Colitis 17, Supplement_1 (January 30, 2023): i785—i786. http://dx.doi.org/10.1093/ecco-jcc/jjac190.0788.

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Abstract Background Upadacitinib (UPA) and tofacitinib (TOFA) are Janus kinase (JAK) inhibitors approved for the treatment of patients (pts) with moderately to severely active ulcerative colitis (UC), but evidence on their comparative efficacy and safety is limited. This study conducted a placebo (PBO)-anchored matching-adjusted indirect comparison (MAIC) of efficacy and safety induction outcomes between UPA and TOFA. Methods Pts received oral UPA 45 mg once daily or PBO for 8 weeks in the phase 3 induction studies U-ACHIEVE Induction (NCT02819635) and U-ACCOMPLISH (NCT03653026), and oral TOFA 10 mg twice daily or PBO for 8 weeks in phase 3 OCTAVE 1 and 2 Induction trials (NCT01458951, NCT01465763). MAIC of efficacy outcomes was conducted for bio-naïve and bio-failure pts. These included clinical remission per full Mayo score (FMS; FMS ≤2 with no subscore >1), clinical response per FMS (decrease from baseline in FMS ≥3 points and ≥30%, with a decrease in rectal bleeding score [RBS] of ≥1 or an absolute RBS of 0 or 1), and endoscopic improvement (EI; endoscopic subscore [ES] 0 or 1). The overall population was used to assess endoscopic remission (ER; ES of 0) and safety outcomes including any adverse events (AEs), serious AEs (SAEs) and discontinuation (DC) due to AEs. Baseline characteristics of age, gender, extent and duration of disease, FMS, and corticosteroid use from UPA trials were weighted to match reported OCTAVE pts for primary efficacy outcomes, plus weight, C-reactive protein, and haemoglobin for ER and safety outcomes. Numbers needed to treat/harm (NNT/NNH) were calculated as the inverse of the difference in proportions achieving efficacy/safety outcomes between UPA and TOFA. Results The MAIC used data from 961 and 977 UPA pts for primary efficacy and ER/safety outcomes, respectively, and 1,139 TOFA pts. A greater proportion of pts receiving UPA vs TOFA in bio-naïve and bio-failure groups achieved clinical remission, clinical response, and EI (p <0.05, Table 1). PBO-adjusted differences between UPA vs TOFA for clinical remission, clinical response, and EI were 14.6%, 23.0%, and 25.1%, respectively, for bio-naïve pts and 8.5%, 27.7%, and 14.3% for bio-failed pts. ER was also higher in UPA vs TOFA (8.6% difference, p < 0.001). AEs and SAEs were not statistically different between UPA and TOFA pts, but proportion of DC due to AEs were lower in UPA vs TOFA (p < 0.05, Table 2). NNT/NNH analysis showed a favorable benefit-risk profile of UPA vs TOFA. Conclusion Pts with moderately to severely active UC achieved greater clinical efficacy and similar safety during induction treatment with UPA compared to TOFA based on MAIC, suggesting a favorable benefit-risk profile of UPA in the JAK class.

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Chovancova, Jana, and Emília Huttmanová. "Consumer Attitude and Behavior towards Bio-products in Slovak Republic." Journal of Economic Development, Environment and People 3, no. 2 (July 1, 2014): 45. http://dx.doi.org/10.26458/jedep.v3i2.72.

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Bio-product market is very challenging and developing rapidly. Consumers have raised great interest in healthy and tasty diet with high nutritional compounds, confidence in food safety, environmental and animal welfare concern and also sustainability. The aim of this paper is to analyze consumer attitude and behavior as well as the factors influencing purchasing behavior when deciding to buy bio-products or their substitutes. The essential part of the article presents the partial results of the research, which was directed to consumers buying bio-products in Slovakia.

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Qin, Ge, Ya Fei Deng, Hong Mei Zhou, and Juan Juan Li. "Review of Iridium Oxide Surface Modification on Bio-Electrodes." Advanced Materials Research 1027 (October 2014): 191–94. http://dx.doi.org/10.4028/www.scientific.net/amr.1027.191.

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Surface modification has become a common method to improve the interface property of electrodes. The existing problems on the interface of implanted electrodes are introduced in biocompatibility, corrosion resistance, electrochemical properties in this article. Iridium oxide is the most widely used material for implanted bio-electrodes because of its good biocompatibility, corrosion resistance, high safety injection charge density and low impedance. And preparation methods of the iridium oxide modifying bio-electrodes are described and discussed for enhancing the long-term implanting stability of the bio-electrodes.

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Lv, Yu, Ruochen Pu, Yining Tao, Xiyu Yang, Haoran Mu, Hongsheng Wang, and Wei Sun. "Applications and Future Prospects of Micro/Nanorobots Utilizing Diverse Biological Carriers." Micromachines 14, no. 5 (April 29, 2023): 983. http://dx.doi.org/10.3390/mi14050983.

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Targeted drug delivery using micro-nano robots (MNRs) is a rapidly advancing and promising field in biomedical research. MNRs enable precise delivery of drugs, addressing a wide range of healthcare needs. However, the application of MNRs in vivo is limited by power issues and specificity in different scenarios. Additionally, the controllability and biological safety of MNRs must be considered. To overcome these challenges, researchers have developed bio-hybrid micro-nano motors that offer improved accuracy, effectiveness, and safety for targeted therapies. These bio-hybrid micro-nano motors/robots (BMNRs) use a variety of biological carriers, blending the benefits of artificial materials with the unique features of different biological carriers to create tailored functions for specific needs. This review aims to give an overview of the current progress and application of MNRs with various biocarriers, while exploring the characteristics, advantages, and potential hurdles for future development of these bio-carrier MNRs.

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Ferrante, M., Q. Cao, T. Fujii, A. Rausch, E. Neimark, A. Song, K. Wallace, et al. "OP25 Patients with moderate to severe Crohn’s Disease with and without prior biologic failure demonstrate improved endoscopic outcomes with risankizumab: Results from phase 3 induction and maintenance trials." Journal of Crohn's and Colitis 16, Supplement_1 (January 1, 2022): i027—i028. http://dx.doi.org/10.1093/ecco-jcc/jjab232.024.

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Abstract Background Risankizumab (RZB), a selective interleukin-23 inhibitor, demonstrated clinically meaningful improvements in endoscopic outcomes in patients with moderate to severe Crohn’s disease (CD) during two phase 3 induction trials (ADVANCE and MOTIVATE) and the maintenance study (FORTIFY). Here, we compared the efficacy of RZB in inducing and maintaining improvements in endoscopic outcomes in patients with CD who demonstrated intolerance and/or inadequate response (IR) to biologic therapies (with prior bio-failure) versus those who demonstrated IR to conventional therapies only (without prior bio-failure). Methods Data included in this subgroup analysis included pooled data from patients randomized to receive intravenous (IV) RZB 600mg (N=527) or placebo (PBO) IV (N=362) every 4 weeks (wks) for 12wks during induction (ADVANCE+MOTIVATE), and data from patients receiving subcutaneous (SC) RZB 360mg (N=141) or withdrawn from RZB IV to receive PBO SC (withdrawal [PBO SC], N=164) every 8wks for 52-wks during maintenance. At Wks 12 and 52, endoscopic response, endoscopic remission, ulcer-free endoscopy (absence of ulceration), and deep remission (Wk52 only) were evaluated both in the overall population and in subpopulations of patients with and without prior bio-failure. (Endpoints are defined in Table footnotes). Safety was assessed throughout the studies. Results Approximately three-quarters of randomized patients included in this subgroup analysis had prior bio-failure (ADVANCE+MOTIVATE: 75.4%; FORTIFY: 73.8%). Higher rates of endoscopic response, endoscopic remission, and ulcer-free endoscopy were observed at Wk12 among patients receiving induction with RZB IV versus PBO IV. Subgroup analysis demonstrated treatment effects with risankizumab in patient subpopulations with and without prior bio-failure, with greater adjusted differences versus PBO in patients without prior bio-failure (Figure). At Wk52, endoscopic response, endoscopic remission, ulcer-free endoscopy, and deep remission rates favored RZB SC compared to withdrawal (PBO SC). Again, treatment effects were observed in patients with and without prior bio-failure, with greater adjusted differences versus withdrawal (PBO SC) in patients without prior bio-failure. RZB maintenance treatment was well-tolerated and no new safety signals were observed. The safety profile of RZB has been reported previously.1,2 Conclusion Induction and maintenance therapy with risankizumab achieved higher rates for endoscopic endpoints in patients with moderate to severe Crohn’s disease versus placebo, regardless of prior bio-failure status. However, numerically higher efficacy rates were observed in patients without prior bio-failure. 1 D’Haens, G. et al. in DDW 2021 2 Ferrante, M. et al. in UEGW 2021

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Zhang, Jia-Yu, Ke Liu, Ruo-Xi Liu, and Bao-Hua Xu. "Safety and Efficacy of Midface Augmentation Using Bio-Oss Bone Powder and Bio-Gide Collagen Membrane in Asians." Journal of Clinical Medicine 12, no. 3 (January 26, 2023): 959. http://dx.doi.org/10.3390/jcm12030959.

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(1) Background: Asians tend to have a regressive midface. Midface augmentation is an effective treatment, and various materials have been used as fillers for this purpose. Bio-Oss bone powder has a strong positive effect on promoting new bone regeneration, and has been used in the dental field for over 30 years. However, it has not been used and reported as a filler in midface augmentation. (2) Objective: To evaluate the safety and efficacy of midface augmentation using Bio-Oss bone powder in treating midface retrusion and resulting nasolabial folds, and to develop a predictive model for patient satisfaction. (3) Methods: 85 patients underwent midface augmentation through an intraoral approach with Bio-Oss. Treatment efficacy was assessed by blinded investigators. The data on safety were collected from patient interviews at each follow-up visit. A questionnaire was used for investigating patient satisfaction. The influencing factors of satisfaction were analyzed by univariate and multivariate analysis. A nomogram to predict the risk of dissatisfaction was built based on significant factors with R software. Results: Compared to baseline, there was a significant improvement (p < 0.001) in Wrinkle Severity (4) Rating Scale scores at week 24, with a mean decrease of 0.52 ± 0.57. The aesthetic improvement rate evaluated by the Global Aesthetic Improvement Scale was 92.9%. Four mild treatment-related adverse events were noted. The majority of patients were satisfied overall. A nomogram with good prediction performance was plotted. (5) Conclusions: This new procedure yielded safe and satisfactory aesthetic results. A nomogram with good test performance and discriminative ability was established for predicting patient satisfaction.

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Dashtizadeh, Zahra, Aidy Ali, and Abdan Khalina. "A Review of Non-Destructive Thermography Techniques Toward Structural Integrity of Bio-Composites." Key Engineering Materials 471-472 (February 2011): 103–8. http://dx.doi.org/10.4028/www.scientific.net/kem.471-472.103.

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It is well known those two popular methods of testing; destructive testing based on fracture mechanics and non-destructive testing (NDT) which does not make any damage in the specimen. NDT was first used for military purpose but nowadays it is used widely in many fields such as composite materials, medical purposes, fire safety, laser welding, food safety and quality and characterization of materials. The aim of this paper is to review the recent advancement of thermography non-destructive methods especially in testing a quality of bio-composites materials. The review reveals the advantages and disadvantages of pursuing any of the available methods in NDT on bio composite materials.

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Reinisch, W., R. Panaccione, M. Duijvestein, D. Ceballos Santos, G. Y. Melmed, S. Xuan, L. Wegrzyn, G. Levy, D. Ilo, and Y. Sanchez Gonzalez. "P546 Comparative efficacy and safety of upadacitinib versus ustekinumab as induction therapy in patients with moderately to severely active ulcerative colitis: A matching-adjusted indirect comparison." Journal of Crohn's and Colitis 17, Supplement_1 (January 30, 2023): i672—i673. http://dx.doi.org/10.1093/ecco-jcc/jjac190.0676.

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Abstract Background Upadacitinib (UPA), an oral Janus kinase inhibitor, and ustekinumab (UST), a parenteral IL-12/23 inhibitor, are approved therapies for patients (pts) with moderately to severely active Ulcerative Colitis (UC). In the absence of head-to-head data, we conducted a placebo (PBO)-anchored matching-adjusted indirect comparison (MAIC) to compare efficacy and safety of UPA vs UST during induction. Methods Pts received UPA 45 mg oral, once daily for 8 weeks or PBO in the phase 3 studies U-ACHIEVE (NCT02819635) and U-ACCOMPLISH (NCT03653026), and UST 6 mg/kg IV at week 0 with 8-week follow up or PBO in the phase 3 study UNIFI (NCT02407236). Efficacy outcomes were stratified by previous biologic exposure (ie, no prior exposure [bio-naïve] or inadequate response, loss of response, or intolerance to biologics [bio-failed]). Baseline characteristics for age, gender, extent and duration of disease, total Inflammatory Bowel Disease Questionnaire score, total Mayo score, high-sensitivity CRP, faecal calprotectin levels, weight, and UC medication use from the UPA trials were weighted to match the UNIFI trial. Efficacy outcomes at Week 8 were clinical remission per full Mayo score (FMS; FMS ≤2 with no subscore >1), clinical response (decrease in FMS ≥3 points and ≥30%, plus a decrease in rectal bleeding score [RBS] of ≥1 or an absolute RBS of 0 or 1), endoscopic improvement (endoscopic subscore 0 or 1), and histologic-endoscopic mucosal improvement (HEMI). Safety outcomes evaluated in the overall population were adverse events (AEs) and serious AEs (SAEs), comprising the only safety assessments consistently collected across trials. Numbers needed to treat/harm (NNT/NNH) were calculated as the inverse of the difference in proportions achieving efficacy/safety outcomes between UPA and UST. Results The MAIC included 824 UPA and 625 UST pts with efficacy data and 839 UPA and 639 UST pts with safety data. A greater proportion of pts receiving UPA vs UST in bio-naïve and bio-failed groups achieved clinical remission, endoscopic improvement, and HEMI after weighting (p≤0.01, Table 1) with NNTs <10. In bio-naïve pts, differences in the proportion of pts with clinical remission, clinical response, endoscopic improvement, and HEMI for UPA vs UST were 0.172, 0.146, 0.312, and 0.255, respectively, and 0.105, 0.235, 0.135, and 0.118 for bio-failed pts. AEs and SAEs were not statistically different between UPA and UST. Conclusion During induction, greater efficacy with similar safety was observed with UPA vs UST for pts with moderately to severely active UC based on MAIC. Potential bias due to unobserved confounders may exist with MAIC methodology. Further analyses to assess longer-term outcomes are warranted.

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Feklisova, V. N., P. V. Kulach, I. M. Nityaga, and A. I. Laishevtsev. "USE OF BIO-PRESERVATIVES BASED ON BACTERIOPHAGES TO ENSURE FOOD SAFETY." Problems of Veterinary Sanitation, Hygiene and Ecology 1, no. 1 (2021): 79–85. http://dx.doi.org/10.36871/vet.san.hyg.ecol.202101012.

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Serguei, Maksimov K., Soukhov D. Nikolai, and Maksimov S. Kirill. "Safety in large-scale manufacturing of nanoparticles for bio-medical use." Emerging Materials Research 1, no. 1 (February 2012): 49–60. http://dx.doi.org/10.1680/emr.11.00005.

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Kaur, Amarinder, Naureen Dhillon, Simarpreet Singh, and Ramandeep Singh Gambhir. "MRI: an update and review on bio-effects and safety considerations." International Journal of Research in Medical Sciences 5, no. 3 (February 20, 2017): 759. http://dx.doi.org/10.18203/2320-6012.ijrms20170620.

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Diagnostic imaging technologies such as magnetic resonance (MR) are vital to catching signs of disease early and high quality diagnosis for treatment planning. However, some patients are unable to take advantage of its life saving capabilities. The procedures can be claustrophobic and the contraindications of MRI in patients having implants, pacemakers and also the risks associated with the use of cryogens, contrast agents etc. So this article provides an update on review on the bio effects and safety considerations for both patient and health practitioner with respect to the use of clinical MRI.

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Bonwick, Graham, and Catherine S. Birch. "Innovation in bio‐based food contact materials: food safety and quality." International Journal of Food Science & Technology 56, no. 8 (June 30, 2021): 3653–54. http://dx.doi.org/10.1111/ijfs.15191.

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Haar, Gail ter. "Standardization of Ultrasound Exposure Reporting for Bio-Effects and Safety Studies." Ultrasound 18, no. 1 (February 2010): 28–30. http://dx.doi.org/10.1258/ult.2009.009007.

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Li, Jun, Lei Kang, Yanhao Yu, Yin Long, Justin J. Jeffery, Weibo Cai, and Xudong Wang. "Study of long-term biocompatibility and bio-safety of implantable nanogenerators." Nano Energy 51 (September 2018): 728–35. http://dx.doi.org/10.1016/j.nanoen.2018.07.008.

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Ahmadi, Farzaneh, Ian V. McLoughlin, Sunita Chauhan, and Gail ter-Haar. "Bio-effects and safety of low-intensity, low-frequency ultrasonic exposure." Progress in Biophysics and Molecular Biology 108, no. 3 (April 2012): 119–38. http://dx.doi.org/10.1016/j.pbiomolbio.2012.01.004.

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Ong, K. J., J. A. Shatkin, K. Nelson, J. D. Ede, and T. Retsina. "Establishing the safety of novel bio-based cellulose nanomaterials for commercialization." NanoImpact 6 (April 2017): 19–29. http://dx.doi.org/10.1016/j.impact.2017.03.002.

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Funeh, Cyprine Neba, Jessica Bridoux, Thomas Ertveldt, Timo W. M. De Groof, Dora Mugoli Chigoho, Parinaz Asiabi, Peter Covens, Matthias D’Huyvetter, and Nick Devoogdt. "Optimizing the Safety and Efficacy of Bio-Radiopharmaceuticals for Cancer Therapy." Pharmaceutics 15, no. 5 (April 30, 2023): 1378. http://dx.doi.org/10.3390/pharmaceutics15051378.

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The precise delivery of cytotoxic radiation to cancer cells through the combination of a specific targeting vector with a radionuclide for targeted radionuclide therapy (TRT) has proven valuable for cancer care. TRT is increasingly being considered a relevant treatment method in fighting micro-metastases in the case of relapsed and disseminated disease. While antibodies were the first vectors applied in TRT, increasing research data has cited antibody fragments and peptides with superior properties and thus a growing interest in application. As further studies are completed and the need for novel radiopharmaceuticals nurtures, rigorous considerations in the design, laboratory analysis, pre-clinical evaluation, and clinical translation must be considered to ensure improved safety and effectiveness. Here, we assess the status and recent development of biological-based radiopharmaceuticals, with a focus on peptides and antibody fragments. Challenges in radiopharmaceutical design range from target selection, vector design, choice of radionuclides and associated radiochemistry. Dosimetry estimation, and the assessment of mechanisms to increase tumor uptake while reducing off-target exposure are discussed.