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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
Moderna Therapeutics , United States
CMC Therapeutic Area Lead
Regulatory CMC Considerations for Oligonucleotide-based Gene Therapy Products: A CBER Perspective
Brian Stultz, MS
FDA, United States
Staff Scientist, Division of Cellular and Gene Therapies
Panelist
Silke Klick, PhD
AstraZeneca, Sweden
Regulatory Director CMC
Panelist
Andreas Kuhn, PhD
Biontech SE, Germany
Senior Vice President RNA Biochemistry & Manufacturing
Panelist
James D. Thompson, PhD
Moderna Therapeutics , United States
CMC Therapeutic Area Lead
Panelist
Brian Stultz, MS
FDA, United States
Staff Scientist, Division of Cellular and Gene Therapies
Panelist
Christine Swenson
Moderna Therapeutics, United States
Head, Global Regulatory Affairs
Panelist
John Talian, PhD
CureVac, United States
Senior Vice President