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

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

FromCMC Live - Chemistry, Manufacturing & Controls


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

FromCMC Live - Chemistry, Manufacturing & Controls

ratings:
Length:
48 minutes
Released:
Oct 30, 2020
Format:
Podcast episode

Description

What We Covered01:19 – 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 career46:23 – 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 LinksDesign Space InPharmatics - LinkedInDesign Space InPharmatics - TwitterEdward Narke on LinkedInRick Offerman on LinkedIn
Released:
Oct 30, 2020
Format:
Podcast episode

Titles in the series (27)

FDA CMC regulations and guidance simplified through examination, real life experiences and risk-based advice. This podcast hopes to educate sponsors and individuals on agency related regulatory CMC matters. We will focus on the critical CMC issues and build programs that enhance drug development. CMC topics will include Regulatory Starting Materials, API and Drug Product Process, Formulation Development, Supply Chains, Analytical Controls. Advocating and interpreting CMC Strategy, directing CMC Operations and Quality Assurance oversight in conjunction with developing CMC submission content that represents the best interests of emerging biotech. NOT INTENDED TO BE PRESCRIPTIVE ADVICE BUT RATHER INTERPRETATION THAT IS RIGHT FOR YOU. Since 2007 we have provided our partners with innovative strategies and exceptional advice intended to enhance program development, product approval, and marketing presence.