Menu Back toSession-5-Track-C-Oligonucleotide-Degradation-Stability-and-the-Question-of-Terminal-Sterilization

DIA/FDA Oligonucleotide-Based Therapeutics Conference


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)

Daniel  DeCollibus, MS

Key Considerations in Terminal Sterilization Development of Oligonucleotides

Daniel DeCollibus, MS

  • Scientist I
  • Biogen, United States
Bianca  Matthee, PharmD, MPharm, MSc

Sterilizing Oligonucleotide-Containing Formulations

Bianca Matthee, PharmD, MPharm, MSc

  • Vice President CMC
  • ProQR Therapeutics, Netherlands
Jonathan  Burgos, PhD

Panelist

Jonathan Burgos, PhD

  • Lieutenant Commander, U.S. Public Health Service Commissioned Corps
  • CDER, FDA, United States