FDA/M-CERSI Co-Processed API Workshop Proceedings
Luke Schenck1, Paresma Patel2, Ramesh Sood2
1Process Research & Development, Merck & Co., Inc., Rahway, New Jersey 07065, United States.
Journal of Pharmaceutical Sciences
|January 13, 2023
Summary
Co-processed active pharmaceutical ingredients (APIs) offer advancements in drug substance properties and manufacturing. This workshop explored regulatory pathways for co-processed APIs from development to commercialization.
Area of Science:
- Pharmaceutical Sciences
- Drug Development
- Regulatory Science
Background:
- Co-processed active pharmaceutical ingredients (APIs) represent a novel technology.
- This technology aims to enhance drug substance physicochemical properties.
- It also seeks to improve drug product manufacturing process robustness.
Purpose of the Study:
- To summarize discussions from the M-CERSI Workshop on Co-processed API.
- To examine advances in co-processed API technology.
- To explore regulatory considerations for commercialization.
Main Methods:
- Workshop presentations from industry, academia, and the FDA.
- Breakout sessions for facilitated stakeholder discussions.
- Compilation of presentation summaries and discussion highlights.
Main Results:
- Recent advances in co-processed API technology were presented.
- Regulatory aspects including classification, CMC strategies, and documentation were discussed.
- Proposals for enabling commercialization of co-processed APIs were explored.
Conclusions:
- Co-processed APIs present a transformative approach to drug development.
- Further visibility into discussions and perspectives on co-processed APIs is needed.
- Regulatory pathways require careful consideration for successful commercialization.
