Alternative adventitious agent detection methods in biopharmaceuticals: A proposal for a structured best practice approach for their evaluation, validation, and implementation

Several alternative and rapid microbiological methods (ARMMs) are available for detecting and enumerating microorganisms and adventitious agents during testing, and regulatory authorities are encouraging industry to adopt these innovative technologies. 

These methods will lead to improved monitoring and assurance of biopharmaceutical processes and manufacturing environments, and shortened cycle times in the supply chain. 

This paper addresses the need for a systematic and best practice approach to evaluating, validating, and implementing these methods to support the adoption of alternative adventitious agent testing (AAT) methods. 

A nine-step framework and common language are described that can be applied by companies wanting to take advantage of the numerous benefits of ARMMs and alternative AATs. This framework is the basis for four collaborative BioPhorum teams working on projects such as alternative and rapid sterility test systems, and automated colony counters. 

Each team applying the framework will produce best-practice papers describing how to take an ARMM through nine steps: 

1. Identify the operational/business need 
2. Define the application 
3. Assess the requirements 
4. Compare options and technologies – landscaping and candidate(s) selection 
5. Develop a business case: technical, quality, and business evaluation and justification 
6. Perform proof-of-concept studies/feasibility studies/pre-validation studies 
7. Validate at pilot or primary site 
8. Deploy global/company-wide qualification of additional laboratories 
9. Define regulatory filings and implementation strategy. 

To help facilitate Step 3, a generic user requirement specification for alternative AATs has been developed by the BioPhorum team and is included as an appendix to this framework. 

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• Create Date 29th June 2022
• DOI https://doi.org/10.46220/2021TR003
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