PT  - JOURNAL ARTICLE
AU  - Krause, Stephan O.
TI  - Using Analytical Platform Technologies to Support Accelerated Product Development—Concept Review and Case Study
AID  - 10.5731/pdajpst.2021.012647
DP  - 2022 May 01
TA  - PDA Journal of Pharmaceutical Science and Technology
PG  - 248--262
VI  - 76
IP  - 3
4099  - http://journal.pda.org/content/76/3/248.short
4100  - http://journal.pda.org/content/76/3/248.full
SO  - PDA J Pharm Sci Technol2022 May 01; 76
AB  - 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.