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.
Rapid Micro
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A systematic approach for the evaluation, validation, and implementation of automated colony counting systems
Mar 2022 | Alternative and Rapid Micro Methods, Deliverable, Deliverables Report, Fill Finish, POI - Fill Finish, Publication
This paper describes a systematic approach to the evaluation, equipment qualification, and deployment of automated colony counting systems, which can be applied by biopharmaceutical companies wanting to take advantage of the numerous benefits.