Applied Biosafety最新文献_第2页

Boundary Integrity Testing of Containment Level 3 (Biological Safety Level 3) Laboratories 安全壳3级(生物安全3级)实验室边界完整性测试

Applied Biosafety Pub Date : 2023-11-14 DOI: 10.1089/apb.2023.0017

Cory Ziegler, Gilles Tremblay

{"title":"Boundary Integrity Testing of Containment Level 3 (Biological Safety Level 3) Laboratories","authors":"Cory Ziegler, Gilles Tremblay","doi":"10.1089/apb.2023.0017","DOIUrl":"https://doi.org/10.1089/apb.2023.0017","url":null,"abstract":"Background: Containment Level 3 (CL3) laboratories may require boundary integrity testing. Existing guidelines for CL3 room leakage are often subjective, lacking a definitive standard for what constitutes a “sealed” room. Methods: This study reviews global biocontainment guidelines and standards, and it compares multiple test results from global CL3 facilities by standardizing test data to an equivalent test pressure of 250 Pa. Results: Our analysis revealed that 55% of rooms constructed using typical CL3 methodologies met the proposed testing criteria. The United States Department of Agriculture (USDA) Agricultural Research Service (ARS) greenhouse leakage rate acceptance criterion of 0.139 L/s per square meter (0.027 cfm per square foot) at a room differential pressure of 250 Pa was found to be a challenging, yet achievable standard. Conclusions: A two-step process is recommended for boundary integrity testing: (1) Initial leaks are identified using smoke pencil or soap bubble tests, followed by necessary repairs; (2) The room is then subjected to quantifiable leakage rate testing to verify it meets minimum requirements. In the absence of definitive local guidelines, we recommend the published ARS greenhouse leakage rate at a room differential pressure of 300 Pa of 0.152 L/s per square meter of surface area as an acceptable criterion for testing construction boundaries of CL3 laboratories built using current CL3 construction practices. For primary containment CL3 rooms, a more stringent criterion following the German Verein Deutscher Ingenieure guidelines at a room pressure differential of 250 Pa is noted as 0.03620 L/s per square meter of room surface area is more appropriate.","PeriodicalId":7962,"journal":{"name":"Applied Biosafety","volume":"8 8","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-11-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"136229562","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

The Importance and Challenges of Implementing and Maintaining Biorepositories for High-Consequence Veterinary and One Health Pathogens in South-East Asia 东南亚实施和维护高后果兽医和单一卫生病原体生物储存库的重要性和挑战

Applied Biosafety Pub Date : 2023-10-23 DOI: 10.1089/apb.2023.0006

Malinee Oyuchua, Jarunee Siengsanan-Lamont, Kim Khanh Le, Somjai Kamolsiripichaiporn, Jeeranan Areerob, Pacharee Thongkamkoon, Watthana Theppangna, Phouvong Phommachanh, Sothyra Tum, Barbara Johnson, Stuart D. Blacksell

{"title":"The Importance and Challenges of Implementing and Maintaining Biorepositories for High-Consequence Veterinary and One Health Pathogens in South-East Asia","authors":"Malinee Oyuchua, Jarunee Siengsanan-Lamont, Kim Khanh Le, Somjai Kamolsiripichaiporn, Jeeranan Areerob, Pacharee Thongkamkoon, Watthana Theppangna, Phouvong Phommachanh, Sothyra Tum, Barbara Johnson, Stuart D. Blacksell","doi":"10.1089/apb.2023.0006","DOIUrl":"https://doi.org/10.1089/apb.2023.0006","url":null,"abstract":"Introduction: Emerging infectious diseases pose a threat to public health and the economy, especially in developing countries. Southeast Asian veterinary laboratories handle numerous high-risk pathogens, making pathogen accountability crucial for safe handling and storage. Methods: Thirteen veterinary laboratories in Cambodia (n = 1), Lao People's Democratic Republic (n = 1), and Thailand (n = 11) participated in a study conducted between 2019 and 2020. Data were collected using a questionnaire, group discussions, and interviews. Conclusion: Significant gaps in biosecurity and biorepository management were recognized and discussed in the context of regional biosafety and biosecurity. Laboratories could use the findings and recommendations of the study to develop or improve their pathogen inventory and biosecurity systems. Governments play a significant role in setting standards and regulations and providing necessary support for laboratories to maintain inventory controls sustainably and have a very important role to play in ensuring biosafety and biosecurity compliance.","PeriodicalId":7962,"journal":{"name":"Applied Biosafety","volume":"2002 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-10-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135412665","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Practical Considerations for Navigating Withdrawal from the Federal Select Agent Program 退出联邦特工选拔计划的实际考虑

Applied Biosafety Pub Date : 2023-10-19 DOI: 10.1089/apb.2023.0014

Scott J. Patlovich, Kristin G. King, Robert J. Emery, Zackary B. Becker, Rebecca B. Kairis

{"title":"Practical Considerations for Navigating Withdrawal from the Federal Select Agent Program","authors":"Scott J. Patlovich, Kristin G. King, Robert J. Emery, Zackary B. Becker, Rebecca B. Kairis","doi":"10.1089/apb.2023.0014","DOIUrl":"https://doi.org/10.1089/apb.2023.0014","url":null,"abstract":"Introduction: Clear guidance is provided by the Federal Select Agent Program (FSAP) to assist registered entities in nearly all facets of compliance with the Federal select agent regulations (7 CFR Part 331; 9 CFR Part 121; 42 CFR Part 73). If a registered entity chooses to discontinue its registration, detailed instructions for registration withdrawal are deeply embedded within a document entitled “eFSAP Form 1 Amendment Instructions,” which is found on the FSAP website within the electronic Federal Select Agent Program (eFSAP) Resource Center. Methods: Using the information found within the eFSAP Form 1 Amendment Instructions, as well as extensive written and verbal guidance provided by the lead assigned entity point of contact at the FSAP, we completed the FSAP withdrawal process during a 12-month period between 2022 and 2023. Discussion: This commentary shares our recent professional experiences navigating the FSAP withdrawal process at the University of Texas Health Science Center at Houston (UTHealth Houston). Successes, challenges, and lessons learned are shared so that others planning or considering withdrawing may benefit from our experience. Conclusion: The resources provided for withdrawal within the eFSAP Form 1 Amendment Instructions are relatively basic, and additional details are not currently found in other FSAP guidance documents. Therefore, direct communication and support from the FSAP to the entity Responsible Officials are imperative to ensure a safe, secure, and compliant withdrawal.","PeriodicalId":7962,"journal":{"name":"Applied Biosafety","volume":"6 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-10-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135729062","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Comparison of Brazilian High- and Maximum-Containment Laboratories Biosafety and Biosecurity Regulations to Legal Frameworks in the United States and Other Countries: Gaps and Opportunities 巴西高隔离和最高隔离实验室生物安全和生物安保条例与美国和其他国家法律框架的比较:差距和机遇

Applied Biosafety Pub Date : 2023-09-13 DOI: 10.1089/apb.2023.0005

André de Oliveira Mendonça, Kurt Allen Zuelke, Melissa M. Kahl-Mcdonagh, Claudio Mafra

{"title":"Comparison of Brazilian High- and Maximum-Containment Laboratories Biosafety and Biosecurity Regulations to Legal Frameworks in the United States and Other Countries: Gaps and Opportunities","authors":"André de Oliveira Mendonça, Kurt Allen Zuelke, Melissa M. Kahl-Mcdonagh, Claudio Mafra","doi":"10.1089/apb.2023.0005","DOIUrl":"https://doi.org/10.1089/apb.2023.0005","url":null,"abstract":"Introduction: Although the United States and other countries have implemented comprehensive legislation, regulations, and policies to support biosafety and biosecurity of high- and maximum-containment laboratories, Brazil's legislation has notable gaps and inconsistencies. Objective: To evaluate the Brazilian approach to ensuring nationwide biosafety and biosecurity oversight and governance of high- and maximum-containment laboratories. Methods: A systematic gap analysis was conducted to compare Brazilian biosafety and biosecurity legislation, regulations, and policies with their international counterparts, with a particular focus on the oversight and governance of high- and maximum-containment laboratories. Results: We found that Brazilian biosafety and biosecurity legislation, regulations, and policies have relevant gaps. Governance and regulatory oversight of Brazil's high- and maximum-containment laboratories are decentralized with variable levels of adherence to commonly accepted global biosafety and biosecurity compliance standards. These findings represent a limitation not only to governance but also to the preparedness to face current and future challenges related to emergent infectious diseases in Brazil. Enhancing the Brazilian legal framework on laboratory biosafety and biosecurity is necessary and urgent. Reviewing the lessons learned and regulations applied in the United States and other international frameworks helped identify potential areas for improving Brazil's ability to inventory and manage its diverse biocontainment laboratory capabilities and assure these valuable resources align with national needs and priorities. Conclusion: The Brazilian government has an opportunity to revise and improve upon a national set of legislation, regulations, and policies for its high- and maximum-containment laboratories, taking advantage of legislation and guidelines published by other countries.","PeriodicalId":7962,"journal":{"name":"Applied Biosafety","volume":"9 10 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-09-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135781253","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

An Industry Proposal for a Cell and Gene Therapy Safety Data Sheet. 细胞和基因治疗安全性数据表的行业提案。

IF 0.5

Applied Biosafety Pub Date : 2023-09-01 Epub Date: 2023-09-12 DOI: 10.1089/apb.2023.0009

Qirong Wu, Shana Elkind, Francine Preston, Michael Wachala, Erin Dunn, Sarah K White, Dirk Windhorst, Kimberly DiGiandomenico, Colin McGuire, Herbert Brok, Rachel Hodges

{"title":"An Industry Proposal for a Cell and Gene Therapy Safety Data Sheet.","authors":"Qirong Wu, Shana Elkind, Francine Preston, Michael Wachala, Erin Dunn, Sarah K White, Dirk Windhorst, Kimberly DiGiandomenico, Colin McGuire, Herbert Brok, Rachel Hodges","doi":"10.1089/apb.2023.0009","DOIUrl":"10.1089/apb.2023.0009","url":null,"abstract":"Introduction: A safety data sheet (SDS) is an established hazard communication tool for chemicals, for which no comparable document exists in the biotherapeutics industry. As the cell and gene therapy (CGT) field expands, industry leaders have identified a growing need to address this gap in communication of the unique occupational health and safety risks posed by CGT materials and products.Methods: Following the sections of a traditional chemical SDS, information was modified by industry subject matter experts, relevant to CGT biological materials. This guide was developed based on assumptions of a maximum biosafety level 2, and any chemical components present in the material were excluded from the hazard classification.Results: The guide contains necessary information to conduct a workplace risk assessment and communicate the unique workplace hazards posed by potential exposures to the material. The target audience is intended to be entities handling and producing these materials, plus collaborators, contractors, or operations sites receiving and handling the CGT material. An example of a CGT SDS is provided in Table 1.Discussion: The CGT SDS provides industry with a best practice to address an existing gap in hazard communication for CGT. We expect that, as the field evolves, so may the contents. The CGT SDS can be used as a reference for other biological modalities in the field.Conclusions: This initial CGT SDS communicates workplace hazards and assesses the unique risks posed by these biological materials and can assist in creating exposure control plans specific to the workplace hazards.","PeriodicalId":7962,"journal":{"name":"Applied Biosafety","volume":"28 3","pages":"176-191"},"PeriodicalIF":0.5,"publicationDate":"2023-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10510680/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41094684","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

The Biosafety Research Road Map: The Search for Evidence to Support Practices in the Laboratory-Mpox/Monkeypox Virus. 生物安全研究路线图：寻找支持实验室实践的证据-Mpox/猴痘病毒。

IF 1.5

Applied Biosafety Pub Date : 2023-09-01 Epub Date: 2023-09-12 DOI: 10.1089/apb.2022.0045

Stuart D Blacksell, Sandhya Dhawan, Marina Kusumoto, Kim Khanh Le, Kathrin Summermatter, Joseph O'Keefe, Joseph Kozlovac, Salama Suhail Al Muhairi, Indrawati Sendow, Christina M Scheel, Anthony Ahumibe, Zibusiso M Masuku, Allan M Bennett, Kazunobu Kojima, David R Harper, Keith Hamilton

{"title":"The Biosafety Research Road Map: The Search for Evidence to Support Practices in the Laboratory-Mpox/Monkeypox Virus.","authors":"Stuart D Blacksell, Sandhya Dhawan, Marina Kusumoto, Kim Khanh Le, Kathrin Summermatter, Joseph O'Keefe, Joseph Kozlovac, Salama Suhail Al Muhairi, Indrawati Sendow, Christina M Scheel, Anthony Ahumibe, Zibusiso M Masuku, Allan M Bennett, Kazunobu Kojima, David R Harper, Keith Hamilton","doi":"10.1089/apb.2022.0045","DOIUrl":"10.1089/apb.2022.0045","url":null,"abstract":"Introduction: The virus formerly known as monkeypox virus, now called mpoxv, belongs to the Orthopoxvirus genus and can cause mpox disease through both animal-to-human and human-to-human transmission. The unexpected spread of mpoxv among humans has prompted the World Health Organization (WHO) to declare a Public Health Emergency of International Concern (PHEIC).Methods: We conducted a literature search to identify the gaps in biosafety, focusing on five main areas: how the infection enters the body and spreads, how much of the virus is needed to cause infection, infections acquired in the lab, accidental release of the virus, and strategies for disinfecting and decontaminating the area.Discussion: The recent PHEIC has shown that there are gaps in our knowledge of biosafety when it comes to mpoxv. We need to better understand where this virus might be found, how much of it can spread from person-to-person, what are the effective control measures, and how to safely clean up contaminated areas. By gathering more biosafety evidence, we can make better decisions to protect people from this zoonotic agent, which has recently become more common in the human population.","PeriodicalId":7962,"journal":{"name":"Applied Biosafety","volume":"28 3","pages":"152-161"},"PeriodicalIF":1.5,"publicationDate":"2023-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10510687/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41112102","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

The Biosafety Research Road Map: The Search for Evidence to Support Practices in the Laboratory-Zoonotic Avian Influenza and Mycobacterium tuberculosis. 生物安全研究路线图：寻找证据支持实验室人畜共患禽流感和结核分枝杆菌的做法。

IF 1.5

Applied Biosafety Pub Date : 2023-09-01 Epub Date: 2023-09-12 DOI: 10.1089/apb.2022.0038

Stuart D Blacksell, Sandhya Dhawan, Marina Kusumoto, Kim Khanh Le, Kathrin Summermatter, Joseph O'Keefe, Joseph Kozlovac, Salama Suhail Almuhairi, Indrawati Sendow, Christina M Scheel, Anthony Ahumibe, Zibusiso M Masuku, Allan M Bennett, Kazunobu Kojima, David R Harper, Keith Hamilton

{"title":"The Biosafety Research Road Map: The Search for Evidence to Support Practices in the Laboratory-Zoonotic Avian Influenza and Mycobacterium tuberculosis.","authors":"Stuart D Blacksell, Sandhya Dhawan, Marina Kusumoto, Kim Khanh Le, Kathrin Summermatter, Joseph O'Keefe, Joseph Kozlovac, Salama Suhail Almuhairi, Indrawati Sendow, Christina M Scheel, Anthony Ahumibe, Zibusiso M Masuku, Allan M Bennett, Kazunobu Kojima, David R Harper, Keith Hamilton","doi":"10.1089/apb.2022.0038","DOIUrl":"10.1089/apb.2022.0038","url":null,"abstract":"Introduction: The Biosafety Research Road Map reviewed the scientific literature on a viral respiratory pathogen, avian influenza virus, and a bacterial respiratory pathogen, Mycobacterium tuberculosis. This project aims at identifying gaps in the data required to conduct evidence-based biorisk assessments, as described in Blacksell et al. One significant gap is the need for definitive data on M. tuberculosis sample aerosolization to guide the selection of engineering controls for diagnostic procedures.Methods: The literature search focused on five areas: routes of inoculation/modes of transmission, infectious dose, laboratory-acquired infections, containment releases, and disinfection and decontamination methods.Results: The available data regarding biosafety knowledge gaps and existing evidence have been collated and presented in Tables 1 and 2. The guidance sources on the appropriate use of biosafety cabinets for specific procedures with M. tuberculosis require clarification. Detecting vulnerabilities in the biorisk assessment for respiratory pathogens is essential to improve and develop laboratory biosafety in local and national systems.","PeriodicalId":7962,"journal":{"name":"Applied Biosafety","volume":"28 3","pages":"135-151"},"PeriodicalIF":1.5,"publicationDate":"2023-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10510692/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41094833","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Evaluation of Pressurized Steam Disinfection of Surfaces Contaminated by Mycobacterium terrae: A Surrogate for Mycobacterium bovis. 土分枝杆菌污染表面加压蒸汽消毒的评价：牛分枝杆菌的替代品。

IF 0.5

Applied Biosafety Pub Date : 2023-09-01 Epub Date: 2023-09-12 DOI: 10.1089/apb.2023.0004

Jiewen Guan, Maria Chan, Elizabeth Rohonczy

{"title":"Evaluation of Pressurized Steam Disinfection of Surfaces Contaminated by Mycobacterium terrae: A Surrogate for Mycobacterium bovis.","authors":"Jiewen Guan, Maria Chan, Elizabeth Rohonczy","doi":"10.1089/apb.2023.0004","DOIUrl":"10.1089/apb.2023.0004","url":null,"abstract":"Introduction: Decontamination of farms affected by bovine tuberculosis could be very challenging during outbreaks occurring in the winter with freezing temperatures. Steam treatment has been of practical interest, but information is needed on whether such treatment is able to inactivate the causative agent, Mycobacterium bovis. This study was to evaluate the use of pressurized steam for inactivation of Mycobacterium terrae, a surrogate for M. bovis on various surfaces.Methods: Carrier disks made of steel, wood, or rubber were inoculated with 6.32 ± 0.38 log10 M. terrae. While being held at background temperatures of -20°C, 4°C, or 21°C, these carrier disks were treated with pressurized steam (120°C ± 5°C) for 5, 10, 15, or 20 s. Reduction in colony forming units of M. terrae and temperatures on the top and bottom surfaces of the disks were determined.Results: Complete inactivation of 6 log10 M. terrae on steel and wood disks was achieved by 10 s of steam treatment at all three background temperatures. In comparison, 20 s of steam treatment was needed for the complete inactivation of mycobacteria on rubber disks. Corresponding to the longer treatment time required for mycobacterial inactivation, temperatures on the bottom surface of the rubber disks rose substantially slower than those of the steel and wood disks at all three background temperatures.Conclusion: The results suggested that treatment with pressurized steam has potential for efficient and effective disinfection of surfaces contaminated by mycobacteria at or below freezing temperatures in winter.","PeriodicalId":7962,"journal":{"name":"Applied Biosafety","volume":"28 3","pages":"192-198"},"PeriodicalIF":0.5,"publicationDate":"2023-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10517315/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41102618","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Call for Special Issue Papers: Biosafety and Biosecurity for Synthetic Genomics: Deadline for Manuscript Submission: December 1, 2023. 特刊论文征集：合成基因组学的生物安全与生物安全：稿件提交截止日期：2023年12月1日。

IF 0.5

Applied Biosafety Pub Date : 2023-09-01 Epub Date: 2023-09-12 DOI: 10.1089/apb.2023.29011.cfp

Sarah R Carter, Rocco Casagrande, Scott J Patlovich, David R Gillum

引用次数: 0

Environmental Health and Safety Offers a Biosafety Risk Assessment for a Theoretical Model of a Gene Therapy Process Transfer from Research and Development to Large-Scale Manufacturing. 环境健康与安全为基因治疗过程从研发转移到大规模生产的理论模型提供了生物安全风险评估。

IF 0.5

Applied Biosafety Pub Date : 2023-09-01 Epub Date: 2023-09-12 DOI: 10.1089/apb.2023.0007

Simon Godwin, Shana Elkind, Timmy Carey, Kimberly DiGiandomenico, Alexa Balbo, Jemma Blocksidge, Jessica Olson, Jess Miklosko, Leo Njongmeta, Francine Preston, Rachel Hodges

{"title":"Environmental Health and Safety Offers a Biosafety Risk Assessment for a Theoretical Model of a Gene Therapy Process Transfer from Research and Development to Large-Scale Manufacturing.","authors":"Simon Godwin, Shana Elkind, Timmy Carey, Kimberly DiGiandomenico, Alexa Balbo, Jemma Blocksidge, Jessica Olson, Jess Miklosko, Leo Njongmeta, Francine Preston, Rachel Hodges","doi":"10.1089/apb.2023.0007","DOIUrl":"10.1089/apb.2023.0007","url":null,"abstract":"Introduction: This article provides a strategy by which a manufacturing process with a Biosafety Level 2 (BL2) designation can be downgraded to Biosafety Level 1 (BL1). The principles of the downgrading process are based on the robust contamination controls in clinical and commercial manufacturing, which typically are not part of Research and Development processes. These strict requirements along with the application of current Good Manufacturing Practice (cGMP) principles provide a framework by which processes can be suitably managed and controlled to mitigate biohazard risk, specifically for cell lines that may be contaminated with human pathogenic viral agents.Purpose: We demonstrate how a risk assessment guide was used to define the risk profile of a theoretical process with a human cell line intended for clinical/commercial application. Based on the risk assessment, key BL2 elements were identified as suitable for downgrading, including facility containment controls, emergency spill response plans, and storage and shipping requirements. For various reasons, some aspects of the systems were deemed unsuitable for downgrading due to the severity of the control risk and, therefore, remained at BL2.Summary and conclusions: We have used an established risk assessment guide to show how cGMP compliments and augments biosafety containment. We provide justification for downgrading from BL2 to BL1 for clinical and commercial cell and gene therapy manufacturing with human cell lines.","PeriodicalId":7962,"journal":{"name":"Applied Biosafety","volume":"28 3","pages":"164-175"},"PeriodicalIF":0.5,"publicationDate":"2023-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10510678/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41097542","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0