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Session 6 Track C: Control Strategy and Regulatory Considerations for Manufacture of mRNA Drug Substance
Session Chair(s)
Silke Klick, PhD
Regulatory Director CMC, AstraZeneca, Sweden
Brian Stultz, MS
Staff Scientist, Division of Cellular and Gene Therapies, FDA, United States
This session will provide an overview of the manufacturing strategy for mRNA Drug Substance and how mRNAs differ from synthetic oligonucleotides. The presentations will address key critical quality attributes, describe control strategies, and provide a regulatory overview. The session will include a panel discussion on regulatory considerations for mRNA Drug Substance.
Speaker(s)
Manufacture and Control of mRNA Drug Substance
James D. Thompson, PhD
CMC Therapeutic Area Lead, Moderna Therapeutics , United States
Regulatory CMC Considerations for Oligonucleotide-based Gene Therapy Products: A CBER Perspective
Brian Stultz, MS
Staff Scientist, Division of Cellular and Gene Therapies, FDA, United States
Panelist
Silke Klick, PhD
Regulatory Director CMC, AstraZeneca, Sweden
Panelist
Andreas Kuhn, PhD
Senior Vice President RNA Biochemistry & CMC Development, Biontech SE, Germany
Panelist
James D. Thompson, PhD
CMC Therapeutic Area Lead, Moderna Therapeutics , United States
Panelist
Brian Stultz, MS
Staff Scientist, Division of Cellular and Gene Therapies, FDA, United States
Panelist
Christine Swenson
Head, Global Regulatory Affairs, Moderna Therapeutics, United States
Panelist
John Talian, PhD
Senior Vice President, CureVac, United States
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