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Session 2A: CMC Track: Emerging Trends
Session Chair(s)
Stephen R Sofen, PhD
CMC Team Director
Biogen Idec, United States
This session will focus on the emerging field of mRNA therapeutics and feature two presentations followed by a panel discussion. The presenters will discuss CMC challenges associated with the manufacture of long coding RNAs. Potential topics for discussion include:
• Purity requirements for long RNA
• RNA stability
Speaker(s)
cGMP Manufacturing of mRNA Products: Considerations and Challenges
Gary Lee, PhD
Sangamo BioSciences, Inc., United States
Research Scientist
Manufacturing of Long, Coding RNAs
Andreas Kuhn, PhD
Biontech SE, Germany
Senior Vice President RNA Biochemistry & Manufacturing
Q&A Panel Discussion (Joining the Speakers):
René Thürmer, PhD
Federal Institute for Drugs and Medical Devices, Germany
Deputy Head of the Unit Pharmaceutical Biotechnology BfArM
James D. Thompson, PhD
Moderna Therapeutics , United States
CMC Therapeutic Area Lead
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