Have you encountered challenges or benefits in implementing control strategies for APIs?
A new USP Technical Guide is now available on control strategies for continuous manufacturing of chemically synthesized small molecule drug substances (APIs). It introduces key concepts, typical equipment and process design, and includes an example to illustrate how to develop and report control strategies effectively. What approaches have worked well—or not so well—for you in developing these strategies?
This would not have been possible without the help of Advanced Manufacturing Technologies Advisory Group (AMT-AG) who gave their valuable time and inputs.
Thank you to:
Nima Yazdanpanah (Procegence)
Stephen Born (CONTINUUS Pharmaceuticals)
Krizia Karry (Merck)
Sarang Oka (Hovione)
Efrain Aymat (ThermoFisher)
Nathaly A Movilla Meza (University of Puerto Rico)
Salvador Garcia (Eli Lilly)
Greg Mehos (Greg Mehos & Associates Inc.)
Rohit Lokhande (USP)