Biologics Consortium Plans Collaborative Approach To Rapid Methods Validation
A plan to develop a “best practices” guide on validating rapid analytical methods for biopharmaceuticals is in the works.
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For short-lived cell and gene therapies that must be given to patients before traditional sterility testing results can be obtained, the question is whether less sensitive rapid tests that can be completed in advance might be a better choice. Should manufacturers demonstrate a lack of viable microorganisms, or is it OK merely to show there aren’t enough of them to produce an “infectious dose”?
A biopharmaceutical industry consortium has released a roadmap to help the industry achieve the flexibility and cost reductions needed to deal with a changing business and manufacturing environment. The group is promoting the use of six enabling technologies.
Site-based metrics praised; lot acceptance rates, invalidated OOS rates discouraged. Agency official admits some proposed metrics were “not the best.”