008 Trust the Process with a CMC Process Champion - Dave Adams

What We Covered

• 01:15 – Dave Adams joins the show to discuss his experience with active pharmaceutical ingredients (APIs) and provides examples of how he’s solved problems with APIs in the past
• 09:41 – What Dave looks for in a comprehensive, well thought out development program and how he works and interacts with process engineers
• 15:02 – Dave provides his thoughts on sourcing the highest quality raw materials
• 22:53 – Dave discusses the pilot scale example and the critical role of development
• 32:30 – Dave talks about the importance of presenting a CMO with a well-characterized process and establishing solid relationships with your client and CMO
• 38:26 – Dave explains what tech transfer is and provides suggestions for how CMO’s can ensure they are receiving high quality raw materials
• 42:46 – Dave speaks to the importance of tech transfer procedures and the role of process champions
• 47:58 – Ed, Brian and Meranda thank Dave for joining the show

Tweetable Quotes

“Manufacturing of APIs was very much a technical job, not a scientific process.”

“In production, time is money. The longer it takes to run the process, the more it’s going to cost your company or the more that a CMO is going to charge you to manufacture your product.”

“You need to very carefully scout your suppliers and make good agreements with what it is they’re going to be supplying to you.”

“So yes, you need to investigate every ramification of development. And some of them might lead to surprises – you see in new impurities or new emulsion – and so you’re going to have more development.”

“It helps to have somebody on your side who understands production and knows when you’re being taken advantage of and even upfront when you’re making your contracts.”

“It is very important to have one process owner – process champion – one person who represents the process.”

Relevant Links

Design Space InPharmatics - LinkedIn

Design Space InPharmatics - Twitter

Edward Narke on LinkedIn

Dave Adams on LinkedIn