The BioPhorum CGT Environmental Health and Safety (EHS) workstream offers this downloadable template for CGT institutions to use to assess and mitigate biosafety risk for human-derived cell lines susceptible to adventitious agents.
Adventitious virus and mycoplasma
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This paper provides case studies and best practice guidance for validation of an alternative mycoplasma detection assay. It includes an example of completing a user requirement specification (URS) for evaluating an alternative mycoplasma detection assay, validation and implementation. Strategies are also provided to help identify suitable technologies for defined applications. Finally, a framework is given to demonstrate how a validation protocol for an alternative mycoplasma detection assay can be executed to meet the regulatory expectation that the alternative method is equivalent to or better than the current compendial methods.
BioPhorum member only benchmarking exercise seeking member experience on expectations for mycoplasma testing of cell therapies.
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Alternative adventitious agent detection methods in biopharmaceuticals: A proposal for a structured best practice approach for their evaluation, validation, and implementation
This paper addresses the need for a systematic and best practice approach to the evaluation, validation and implementation of these methods related to adventitious agents testing to support the adoption of alternative adventitious agent testing (AAT) methods. A nine-step framework and common language are described which can be applied by biopharmaceutical companies wanting to take advantage of the numerous benefits of ARMMs and alternative AATs.