Standards efforts and landscape for rapid microbial testing methodologies in regenerative medicine |
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| Authors: | Sheng Lin-Gibson Nancy J Lin Scott Jackson Sowmya Viswanathan Claudia Zylberberg Jacqueline Wolfrum Sudeep Basu Krishnendnu Roy Damian Marshall Richard McFarland Spencer Hoover Rodney Rietze Allison Getz Dawn Henke |
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| Institution: | 1. Biosystems and Biomaterials Division, National Institute of Standards and Technology, Gaithersburg, Maryland, USA;2. University Health Network, Toronto, Canada;3. University of Toronto, Toronto, Canada;4. Akron Biotech, Boca Raton, Florida, USA;5. Massachusetts Institute of Technology Center for Biomedical Innovation, Boston, Massachusetts, USA;6. Frost and Sullivan, San Francisco, California, USA;7. Georgia Institute of Technology, Atlanta, Georgia, USA;8. Cell & Gene Therapy Catapult, London, UK;9. BioFabUSA, Manchester, New Hampshire, USA;10. Centre for Commercialization of Regenerative Medicine, Toronto, Canada;11. Novartis, Cambridge, Massachusetts, USA;12. Standards Coordinating Body for Gene, Cell, and Regenerative Medicines and Cell-Based Drug Discovery, Gaithersburg, Maryland, USA;1. Elite Regenerative Stem Cell Specialists, LLC, Johnstown, Colorado, USA;2. R&D Regenerative Laboratory Resources, LLC, Johnstown, Colorado, USA;3. Colorado Spine Institute, PLLC, Johnstown, Colorado, USA;1. Anthony Nolan Cell Therapy Centre, Nottingham, UK;2. The Anthony Nolan Research Institute, Nottingham, UK;1. Department of Orthopaedics & Traumatology, Stem Cells and Regenerative Medicine Laboratory, Li Ka Shing Institute of Health Sciences, The Chinese University of Hong Kong, Prince of Wales Hospital, Shatin, China;2. Orthopaedic Center, Affiliated Hospital of Guangdong Medical University, Guangdong Medical University, Zhanjiang, China;3. Department of Orthopaedic Surgery, School of Medicine, Stanford University, Stanford, California, USA;4. The CUHK-ACC Space Medicine Centre on Health Maintenance of Musculoskeletal System, The Chinese University of Hong Kong Shenzhen Research Institute, Shenzhen, China;5. Key Laboratory for Regenerative Medicine, Ministry of Education, School of Biomedical Sciences, Faculty of Medicine, The Chinese University of Hong Kong, Shatin, China;6. Department of Orthopaedics and Traumatology, Affiliated Baoan Hospital of Shenzhen, Southern Medical University, People’s Hospital of Baoan District, Shenzhen, China.;1. Seattle Children''s Research Institute, Seattle, Washington, USA;2. University of California San Francisco, San Francisco, California, USA;3. Children''s Hospital Los Angeles, Los Angeles, California, USA;4. Center for Cancer and Immunology Research, Center for Cancer and Blood Disorders, Children''s National Hospital, Washington, DC, USA;5. The George Washington University, Washington, DC, USA;1. Clinical and Diagnostic Hematology, University Hospital Basel, Basel, Switzerland;2. Stem Cell Center of Competence, University Basel, Basel, Switzerland;3. Department of Cancer Immunology, Institute for Cancer Research, Oslo University Hospital, Oslo, Norway;4. Department of Medicine, Huddinge, Center for Infectious Medicine, Karolinska Institutet, Karolinska University Hospital, Stockholm, Sweden |
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| Abstract: | The Standards Coordinating Body for Gene, Cell, and Regenerative Medicines and Cell-Based Drug Discovery (SCB) supports the development and commercialization of regenerative medicine products by identifying and addressing industry-wide challenges through standards. Through extensive stakeholder engagement, the implementation of rapid microbial testing methods (RMTMs) was identified as a high-priority need that must be addressed to facilitate more timely release of products. Since 2017, SCB has coordinated efforts to develop standards for this area through surveys, weekly meetings, workshops, leadership in working groups and participation in standards development organizations. This article describes the results of these efforts and discusses the current landscape of RMTMs for regenerative medicine products.Based on discussions with stakeholders across the field, an overview of traditional culture-based methods and limitations, alternative microbial testing technologies and current challenges, fit-for-purpose rapid microbial testing and case studies, risk-based strategies for selection of novel rapid microbial test methods and ongoing standards efforts for rapid microbial testing are captured here. To this end, SCB is facilitating several initiatives to address challenges associated with rapid microbial testing for regenerative medicine products. Two documentary standards are under development: an International Organization for Standardization standard to provide the framework for a risk-based approach to selecting fit-for-purpose assays primarily intended for cell and gene therapy products and an ASTM standard guide focused on sampling methods for microbial testing methods in tissue-engineered medical products. Working with the National Institute of Standards and Technology, SCB expects to facilitate the process of developing publicly available microbial materials for inter-laboratory testing. These studies will help collect the data necessary to facilitate validation of novel rapid methods. Finally, SCB has been working to increase awareness of, dialog about and participation in efforts to develop standards in the regenerative medicine field. |
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