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
Links Mentioned
Design Space InPharmatics – LinkedIn
Design Space InPharmatics – Twitter
Edward Narke on LinkedIn
Les Mintzmyer on LinkedIn