CMC Live - Chemistry, Manufacturing & Controls11 Sep 2020

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

Denne episoden er hentet fra en åpen RSS-feed og er ikke publisert av Podme. Den kan derfor inneholde annonser.

Episoder(27)

025 - The Parenteral Drug Association & Evolution of Drug Development with Michael Carroll

What We Covered00:55 – Ed, Meranda and Brian welcome today’s guest, Mike Carroll, who speaks to his background in microbiology and product development 04:28 – Mike talks about his involvement in the ...

12 Mar 202131min

024 - Quality Management Systems Explained!

What We Covered00:54 – Ed, Meranda and Brian welcome a special panel of guests to break down today’s topic: Quality Management Systems (QMS) Explained! 07:53 – The panel expounds on the timing necess...

5 Mar 202138min

023 - A Broadway Performance Analogy for API Process Validations with Jim Mencel

What We Covered00:52 – Ed, Meranda and Brian welcome back Jim Mencel who shares his extensive experience with process validation07:46 – The importance of Proven Acceptable Range (PAR) and Critical Pro...

26 Feb 202143min

022 - Filter Validation & How It Impacts Getting Your Product to Market with Shelli Connelly

What We Covered00:51 – Ed, Meranda and Brian introduce today’s guest, Shelli Connelly, who discusses her background and speaks to some of the elements of filter validation 05:41 – Shelli talks about ...

19 Feb 202132min

021 - Regulatory Odd Couple with Ed Narke & Meranda Parascandola

What We Covered00:51 – Meranda and Ed discuss the Regulatory Odd Couple blog series and constructing the CTD Module 3 11:54 – Ed explains the importance of building the Quality Overall Summary (QOS) ...

12 Feb 20211h

020 - Lessons Gleaned from Twenty Five Years of a Regulatory CMC Life with Ed Narke

What We Covered00:54 – Meranda and Brian flip the script by introducing fellow host, Ed Narke as today’s guest01:56 – Ed speaks to his extensive background in CMC and the importance he places on build...

29 Jan 202148min

019 - Complexity of Project Management in Drug Development with Paul Long

What We Covered00:55 – Ed, Brian and Meranda welcome to the show Paul Long who shares his well-rounded background as a project management consultant and speaks to some of the benefits and challenges o...

22 Jan 202143min

018 - 2020: A Year in Review with Ed Narke, Brian Lihou & Meranda Parascandola

What We Covered00:43 – Ed, Brian and Meranda introduce today’s 2020 Year-In-Review show and look back on learnings from Jim Mencel, Dave Adams and Daniel Torok10:11 – Ed, Brian and Meranda reflect bac...

8 Jan 202152min