NHLBI Catalyze Webinar: Product Development to IND - Chemistry, Manufacturing and Controls (CMC)

Event description

Presenter: Carmella S. Moody, PhD

This presentation focuses on developing therapeutics from a Chemistry, Manufacturing, and Controls (CMC) perspective. Information is provided regarding important considerations to keep in mind during development and an overview of data included in the CMC section (Quality Section) for early phase IND submissions.

Webinar presented on July 21, 2021 to an invited audience.

This video is provided for educational purposes only.

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Chapters

2:19
Purpose of CMC
3:00
CMC Relative and to Overall Product Development
3:57
When and Why is CMC considered
4:35
Critical elements of CMC
5:35
CMC is Specific to the Product
6:10
Plan for Success with the right team
7:28
Key Considerations: Analytical Testing
9:40
Key Considerations: Control of Raw Materials
12:50
Key Consideration: Manufacturing
15:55
Drug Master Files (DMF)
22:00
Key Considerations: CGMPs
26:00
Drug Substance CMC Information in CTD Format
29:28
Description of Manufacturing Process and Process Controls
32:11
Impurities
36:45
Specifications
40:40
Analytical Procedures
43:00
Justification of Specification
44:00
Reference Standard of Materials
50:55
Drug Product CMC Information in CTD Format
51:20
Description of Manufacturing Process and Process Controls
52:05
Controls
55:50
Specifications
56:55
Stability Summary and Conclusion
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.