015 - Outsourcing in China: How far can it go?

CMC Live - Chemistry, Manufacturing & Controls

What We Covered

• 00:55 – Ed, Brian and Meranda welcome to the show David Blasingame who speaks to his extensive background as a process chemist as well as the advantages and disadvantages of manufacturing drugs in China
• 10:20 – The importance of person in-plant activity and the White Coat Effect
• 11:29 – David speaks to the issues he’s experienced with employee turnover
• 17:11 – Facts and myths about America’s dependence on medicine from China, overcoming communications issues and the process of dealing with CMOs
• 23:41 – David talks about the benefits of staying with the same drug substance manufacturer and expounds on the reasons why not every program is a fit for China
• 31:55 – Ed, Brian and Meranda thank David for joining the show

Tweetable Quotes

“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.”

Relevant Links

Design Space InPharmatics - LinkedIn

Design Space InPharmatics - Twitter

Edward Narke on LinkedIn

David Blasingame on LinkedIn