TY - JOUR T1 - Using Analytical Platform Technologies to Support Accelerated Product Development – Concept Review and Case Study JF - PDA Journal of Pharmaceutical Science and Technology JO - PDA J Pharm Sci Technol DO - 10.5731/pdajpst.2021.012647 SP - pdajpst.2021.012647 AU - Stephan Oswald Krause Y1 - 2021/01/01 UR - http://journal.pda.org/content/early/2021/10/18/pdajpst.2021.012647.abstract N2 - The number of products being developed for serious conditions that are eligible for expedited programs has been increasing in recent years. This paper presents an industry perspective on how to reduce analytical lifecycle steps when using analytical platform technologies (APT) in support of accelerated biological product development. Strategies for lifecycle steps for APT methods are conceptually reviewed within the framework of supporting 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. ER -