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Session 8 Track 3: CMC Perspective on mRNA Therapeutics
Session Chair(s)
Nedim Emil Altaras, PhD
Senior Vice President, Technical Development
Moderna, United States
The remarkable and rapid advances of SARS-CoV2 mRNA-based vaccines have established the first generation of the many CMC principles for the mRNA-based products. While the industrial manufacturing processes and associated analytical control strategies have been in development for a decade or more, these were scaled-up and readied for commercialization rapidly to meet the needs of pandemic response. The platform nature of mRNA technologies enables common CMC principles, but as application of this flexible technology expands from vaccines to therapeutics, CMC principles will need to diverge or adapt. The sessions will cover these CMC perspectives along with lessons learned and the outlook from both regulatory and industrial viewpoint. The presentations will be followed by a panel discussion with a focus on overcoming the CMC challenges of future mRNA therapeutics.
Learning Objective : At the conclusion of this session, participants should be able to:
- Describe and discuss the key CMC themes that enabled the rapid deployment of mRNA-based vaccines
- Identify the key CMC challenges and potential common ground to overcoming these for the licensure of future mRNA-based therapeutics
- Discuss regulatory and industrial perspective on key CMC issues on the development of mRNA-based products
Speaker(s)
CMC Development of an mRNA-Based Vaccine to Fight COVID-19 – Lessons Learned
Andreas Kuhn, PhD
Biontech SE, Germany
Senior Vice President RNA Biochemistry & CMC Development
Regulatory Perspectives for the Evaluation of the Quality, Safety and Efficacy of Prophylactic mRNA Vaccines
Keith Peden, PhD
FDA, United States
Laboratory Chief, Laboratory of DNA Viruses, DVP, CBER
Panelists
Heide Vera Muckenfuß, DrSc
Paul-Ehrlich-Institut, Germany
Quality assessor for viral vaccines
Panelists
Donald Parsons, PhD
Moderna, United States
Vice President, Early Technical Development and LNP Process Development
Panelists
Olen M. Stephens, PhD
FDA, United States
Chemist Reviewer, CMC Reviewer, CDER/OPQ/ONDP
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