Considerations for External Partnership: Chemistry, Manufacturing, and Controls

Event description

Presenters: Dr. Mark Levi

This is the final webinar in a 3-part series dedicated to effective partnerships with external research/manufacturing organizations. The Catalyze team receives many questions around approaching Contract Research Organizations (CROs), Contract Manufacturing Organizations (CMO), or Contract Development and Manufacturing Organizations (CDMO) to perform necessary studies. This webinar focuses on preparing for and managing partnerships to carry out chemistry, manufacturing, and controls (CMC) activities.

This webinar is presented by Dr. Mark Levi, an expert in regulatory affairs with other 20 years of experience. Dr. Levi will answer common questions about required CMC activities by providing real-world examples. This presentation is meant to give academic and small business investigators a better understanding of the regulatory process and tools to set their product up for regulatory success through partnership.

Webinar presented on February 29, 2024 to an invited audience.

This video is provided for educational purposes only.

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Chapters

00:00
Objectives and Disclaimers
02:04
Background
04:07
Purpose of CMC
05:45
Chemistry, Manufacturing and Controls Legal Basis 21 CFR 312.23(a)(7)
09:45
Plan for Success with the Right Expertise on the CMC Team
11:16
Critical Elements of CMC
12:18
Key Considerations: Control of Raw Materials
16:46
Key Considerations: Analytical Testing (QC)
17:55
Additional CMC Testing Is Specific to the Product
19:10
Phase Appropriate cGMPs for CMC (Generic)
23:33
Key Considerations: Manufacturing
25:46
Key Considerations: Quality Assurance (QA)
27:01
CMC Contract Organizations
29:56
CMO Vendor Selection Criteria
30:48
How to Choose a Contract Organization
35:17
cGMP Requirements for Vendor Qualification
36:03
CMO Audit Process
37:48
Types of Contract Manufacturing Agreements
39:01
Benefits of Contract Manufacturing Organization
41:32
Top 10 Contract Manufacturing Mistakes
42:53
Helpful Links
43:25
Top 10 Contract Manufacturing Mistakes (continued)
45:01
Q&A
This research was, in part, funded by the National Institutes of Health (NIH) Agreement OT2 HL157844-01. The views and conclusions contained in this document are those of the authors and should not be interpreted as representing the official policies, either expressed or implied, of the NIH.