Selecting a Contract Manufacturing Organization (CMO) with ‘Super’ Les Mintzmyer
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Trust the Process with a CMC Process Champion Dave Adams
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Episode Summary
Les Mintzmyer is a Sr. Biologics Manufacturing Consultant at Design Space InPharmatics. Today, Les joins the show to share his experience as a leader in the field of bio-pharmaceutical manufacturing. In this episode, Ed, Brian, Meranda and Les break down the Request for Proposal (RFP) process including three critical factors: verification, qualification and validation. Les speaks to best practices for identifying and selecting the appropriate Contract Manufacturing Organization (sometimes referred to as CDMOs) to partner with.
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. Click To Tweet 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. Click To Tweet Every company wants everything yesterday. Click To Tweet 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. Click To Tweet 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. Click To Tweet 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. Click To TweetLinks Mentioned
Design Space InPharmatics – LinkedIn
