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Session 5 Track C: Oligonucleotide Degradation, Stability, and the Question of Terminal Sterilization
Session Chair(s)
René Thürmer, PhD
Quality Assessor
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