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

International Society of Pharmaceutical Engineering (ISPE) Guide: RNA-Based Therapeutics Manufacturing
We are pleased to announce the imminent publication of 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 we can’t wait to see the full publication on September 30th.
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.
The publication will be available on the ISPE website September 30th HERE.
