David Blasingame is a Director of CMC at Rigel Pharmaceuticals and former Senior Consultant at Design Space InPharmatics. David is an accomplished process chemist with over twenty years of experience in process research and development, API and drug product manufacturing and developing cross-functional and external CMO relationships. In this episode, David, Ed, Meranda and Brian discuss the advantages and disadvantages of outsourcing drug manufacturing to China, the value of person in-plant approach, and the importance of communication and trust in building good partnership relationships.
“One of the key activities for any oversight of manufacturing and any CMO is person in-plant activities.”
“You better make sure you have an easy to manage process…easily transferable, and you really do have to budget to have a presence on that floor. All these things have to be factored into your decision to move into China.”
“If you’re looking for a commercial process that you might be able to take anywhere, I’m not necessarily sure that [China] is the place that you would go.”
“We found it actually paid for itself in having somebody on staff who can speak the language because the communication style and the communication was very different than when we didn’t have one.”
“I think if you’re planning on doing manufacturing in China, plan on being hands on.”
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