CMC Live - Chemistry, Manufacturing & Controls30 Okt 2020

014 - Why now is the most important time for selecting a CMO

What We Covered

01:19 – Ed, Brian and Meranda welcome to the show Dr. Rick Offerman who speaks to his experience as a process chemist, the drug development process and what goes into selecting a solvent
15:41 – The importance of selecting the right CMO partner
19:05 – Questions that must be asked in the beginning of the drug manufacturing process
23:14 – Dr. Rick breaks down best practices in cost-control
30:16 – The importance of the project timeline
40:13 – Dr. Rick takes a moment to recognize those who greatly influenced his career
46:23 – Ed, Brian and Meranda thank Dr. Rick for joining the show

Tweetable Quotes

“A lot of CMOs are now going to a ‘one-stop shop’ type model. So basically they’ll say, ‘Yeah we’ll take you all the way from gram quantities right through commercial. We can do your API and your drug substance.’ But there’s still a lot of smaller shops out there that can do small scale pre-clinical work.”

“Cost is always a factor [in selecting a solvent] but it’s not the major one.”

“You’re gotta have an integrated approach all the way through the system to understand the API that you’re producing, the impurity profile, the crystal morphology, the polymorphs, that sort of thing.”

“Realistically, when you look at the cost of an API as a percentage of a drug product, it’s usually fairly low.”

“If the analytical people aren’t up and ready to go, then when the chemists start running stuff in the hoods, how do they analyze it? We don’t have methods, so we’re kinda going on a wing and a prayer.”

Relevant Links

Design Space InPharmatics - LinkedIn

Design Space InPharmatics - Twitter

Edward Narke on LinkedIn

Rick Offerman on LinkedIn

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Episoder(27)

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021 - Regulatory Odd Couple with Ed Narke & Meranda Parascandola

What We Covered00:51 – Meranda and Ed discuss the Regulatory Odd Couple blog series and constructing the CTD Module 3 11:54 – Ed explains the importance of building the Quality Overall Summary (QOS) ...

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020 - Lessons Gleaned from Twenty Five Years of a Regulatory CMC Life with Ed Narke

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019 - Complexity of Project Management in Drug Development with Paul Long

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018 - 2020: A Year in Review with Ed Narke, Brian Lihou & Meranda Parascandola

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8 Jan 202152min