007 Selecting a Contract Manufacturing Organization (CMO) - ‘Super’ Les Mintzmyer

What We Covered 01:32 – Les Mintzmyer joins the show to discuss his background in biologics manufacturing, speak to CMO selection, and break down the RFP process 08:14 – Les speaks to the criteria he uses to identify the best CMO to work with and the importance of timely correspondence 18:59 – Lessons Les has gleaned from the RFP process throughout the years 24:34 – Challenges of communicating with foreign CMOs, including language and cultural barriers 32:15 – Les provides a brief overview of his experience in bio-pharmaceutical manufacturing 34:05 – Capacity and relationships in the CMO selection process 40:28 – Advice Les would give to those looking to potentially shift to a new CMO and why you should never place too much emphasis on a ‘name brand’ 43:35 – Ed, Brian and Meranda thank Les for joining the show Tweetable Quotes “If you put the effort into getting a very detailed and exact request for proposal written, then the CDMO that is reviewing the request can determine if they have the resources to actually accomplish the task that you’re looking for.” “The nice thing about having a good network is that you can certainly weed out the ones that you don’t want to be involved.” “Every company wants everything yesterday.” “Tell you what, the money they’ll spend on consultants early on is a drop in the bucket compared to change orders and change of scope and misunderstandings that occur later on.” “You can tell a lot about an organization if they’ll let you take a look at their regulatory history, for instance, and look at their maintenance history. Those are two really key things.” “Most of the CMOs, they’re not working at one hundred percent capacity. If they can get seventy or eighty [percent] they’re pretty happy.” Relevant Links Design Space InPharmatics - LinkedIn Design Space InPharmatics - Twitter Edward Narke on LinkedIn Les Mintzmyer on LinkedIn

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007 Selecting a Contract Manufacturing Organization (CMO) - ‘Super’ Les Mintzmyer is an episode from CMC Live - Chemistry, Manufacturing & Controls by DSI.

This episode is 00:45:49 long.

This episode was published on Sep 11, 2020.

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