Back to Agenda
Session 2B (CMC Track): Advances in Oligonucleotide Manufacturing and Control Strategies
Session Chair(s)
Steven Broadbent
Vice President of Quality
NITTO DENKO Avecia Inc., United States
It is widely recognized that process and product knowledge comprise important components of any strategy designed to assure the quality of pharmaceutical products. The first presenter will discuss recent advances in understanding the chemistry of solid phase oligonucleotide synthesis through the application of process analytical technology (PAT). The second presenter will describe efforts aimed at establishing a design space and how the knowledge obtained can be leveraged to develop a robust control strategy. The presentations will be followed by a 30 minute panel discussion.
Speaker(s)
Application of Process Analytical Techniques (PAT) in Oligonucleotide Synthesis
Hüseyin Aygün, PhD
BioSpring GmbH, Germany
Chief Scientific Officer
Design Space Understanding Using LCMS Impurities Analysis
David Macdonald
Agilent Technologies, United States
Director of Commercial Launch
Panelist
David Macdonald
Agilent Technologies, United States
Director of Commercial Launch
Panelist
Anthony Scozzari
Ionis Pharmaceuticals, Inc., United States
VP, Development Chemistry & Manufacturing
Panelist
Hüseyin Aygün, PhD
BioSpring GmbH, Germany
Chief Scientific Officer
Have an account?