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 CMDOs) to partner with.
Run time: 46:07mins
CMC007 - Selecting a Contract Manufacturing Organization (CMO) - ‘Super’ Les Mintzmyer
Video Credit: DSI, a PLG Company
Takeaways:
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
About CMC Live
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.