FDA/M-CERSI Co-Processed API Workshop Proceedings

These proceedings contain presentation summaries and discussion highlights from the University of Mary-land Center of Excellence in Regulatory Science and Innovation (M-CERSI) Workshop on Co-processed API, held on July 13 and 14, 2022. This workshop examined recent advances in the use of co-processed active pharmaceutical ingredients as a technology to improve drug substance physicochemical properties and drug product manufacturing process robustness, and explored proposals for enabling commercialization of these transformative technologies. Regulatory considerations were discussed with a focus on the classification, CMC strategies, and CMC documentation supporting the use of this class of materials from clinical studies through commercialization. The workshop format was split between presentations from industry, academia and the FDA, followed by breakout sessions structured to facilitate discussion. Given co-processed API is a relatively new concept, the authors felt it prudent to compile these proceedings to gain further visibility to topics discussed and perspectives raised during the workshop, particularly during breakout discussions. Disclaimer: This paper reflects discussions that occurred among stakeholder groups, including FDA, on vari-ous topics. The topics covered in the paper, including recommendations, therefore, are intended to capture key discussion points. The paper should not be interpreted to reflect alignment on the different topics by the participants, and the recommendations provided should not be used in lieu of FDA published guidance or direct conversations with the Agency about a specific development program. This paper should not be con-strued to represent FDA's views or policies.& COPY; 2023 American Pharmacists Association. Published by Elsevier Inc. All rights reserved.

Automated summary

This article summarizes the presentation summaries and discussion highlights from the M-CERSI Workshop on Co-processed API, which took place on July 13 and 14, 2022 at the University of Mary-land. The workshop focused on recent advancements in the use of co-processed active pharmaceutical ingredients to improve drug substance properties and manufacturing processes, and explored proposals for commercializing these technologies. Regulatory considerations, including classification and CMC documentation, were discussed, and breakout sessions were held for further discussion.