Key Takeaways The FDA’s Advanced Manufacturing Technology (AMT) Designation Program, established under Section 506L of…

PUBLISHED: International Society of Pharmaceutical Engineering (ISPE) Guide: RNA-Based Therapeutics Manufacturing
Just published! A new International Society of Pharmaceutical Engineering (ISPE) Guide: RNA-Based Therapeutics Manufacturing. Our President and Principal Consultant, James Blackwell, PhD, MBA/MS, was a chapter lead on this project, and it is now available on the ISPE website.
RNA therapeutics are redefining not only how medicines are developed but also how they are manufactured. With this new guide, you will discover how risk-based design, modular facilities, automation, and decentralized production models are shaping the next generation of pharmaceutical manufacturing and enabling the facility of the future.
