Newsletter | September 21, 2022

09.21.22 -- Planning For Outsourced Drug Development Shifts

 
Outsourced Drug Development: Short-Term Solution Or Long-Term Strategy?
 

Through strategic partnerships and outsourcing strategies, pharmaceutical and biotech companies are enabling acceleration through collaboration. As we look forward to the future of drug development, a panel comprising industry consultants and early development experts discussed examining new short- and long-term CDMO and supply chain strategies.

Pinpoint Manufacturing Steps That Require Tighter Control
 

The concept of using a control strategy to ensure product quality was originally devised to increase consumer safety, but following these guidelines also offers benefits to drug producers. Building quality into the product starts with firm control of critical process parameters.

Demonstrating Control Over The Manufacturing Process: QbD Studies
 

Explore the importance of fate and purge studies, which measure the ability of the process to remove impurities and provide evidence of their removal. Fate and purge studies can expose other CPPs or indicate the downstream removal of a CQA from a drug substance.

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