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Bethesda North Marriott Hotel and Conference Center

Oct 28, 2019 7:00 AM - Oct 30, 2019 12:30 PM

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

DIA/FDA Oligonucleotide-Based Therapeutics Conference

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Session 5 Track C: Oligonucleotide Degradation, Stability, and the Question of Terminal Sterilization

Session Chair(s)

René Thürmer, PhD

René Thürmer, PhD

Deputy Head of the Unit Pharmaceutical Biotechnology BfArM

Federal Institute for Drugs and Medical Devices, Germany

This session will focus on the impact of terminal sterilization to oligonucleotide product quality. Formulation development, cycle optimization, and container closure considerations to minimize oligonucleotide degradation during sterilizing heat treatment processes will also be presented. Key learnings will be presented studying oligonucleotide product terminal sterilization as preferred route for sterilization.

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

Jonathan Burgos, PhD

Panelist

Jonathan Burgos, PhD

CDER, FDA, United States

Lieutenant Commander, U.S. Public Health Service Commissioned Corps

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