To protect drug product and drug substances, statistical methods to identify critical process parameters and critical material attributes, as well as and approaches to control them, are needed. A key ...

Critical process parameters (CPPs) and their associated process controls are crucial to drug development and process validation and to the evaluation of every manufacturing unit operation. "…. These ...

Cell therapy developers need purpose-built process monitoring technologies, according to researchers who say better systems would accelerate manufacturing and reduce costs. The conclusion is based on ...

Yokogawa Corporation of America and Repligen announce a collaboration to integrate Yokogawa's OpreX Bio Pilot with Repligen's MAVERICK ®, enhancing automated control of glucose and lactate levels in ...