Abstract
The number of products being developed for serious conditions that are eligible for expedited programs has been increasing in recent years. This article presents an industry perspective on how to reduce analytical life cycle steps when using analytical platform technologies (APT) in support of accelerated biological product development. Strategies for life cycle steps for APT methods are conceptually reviewed within the framework of supporting chemistry, manufacturing, and control (CMC) development acceleration. Reduced method qualification, transfer, and validation studies could be performed, provided that the initially validated test method remains unchanged. A detailed case study is used to illustrate considerations for the initial method validation and subsequent APT verification studies. Considerations for APT implementation are discussed and suggestions are provided for the submission of APT information in regulatory filings.
- © PDA, Inc. 2022
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