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Session 5 Track C: Oligonucleotide Degradation, Stability, and the Question of Terminal Sterilization
Session Chair(s)
René Thürmer, PhD
Deputy Head of the Unit Pharmaceutical Biotechnology BfArM
Federal Institute for Drugs and Medical Devices, Germany
Learning Objective : At the conclusion of this session, participants should be able to:- Estimate the influence of terminal sterilization on the product quality of synthetic oligonucleotides
Speaker(s)
Key Considerations in Terminal Sterilization Development of Oligonucleotides
Daniel DeCollibus, MS
Biogen, United States
Scientist I
Sterilizing Oligonucleotide-Containing Formulations
Bianca Matthee, PharmD, MPharm, MSc
ProQR Therapeutics, Netherlands
Vice President CMC
Panelist
Jonathan Burgos, PhD
CDER, FDA, United States
Lieutenant Commander, U.S. Public Health Service Commissioned Corps