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Session 5B (CMC Track): Analytical Advancements and Oligonucleotide Specifications
Session Chair(s)
Nigel R. Richardson, PhD
Head Analytical Technology & Automation, CMC Analytical
GlaxoSmithKline, United Kingdom
Drug substance and drug product specifications focus on critical quality attributes useful for ensuring safety and efficacy. In this regard, the general requirements to confirm identity, determine strength and assess impurities apply to oligonucleotides. However, the size and complexity of oligonucleotides relative to small molecule drugs can make fulfilling these basic requirements challenging. A review of the state of the art of oligonucleotide analysis will be presented. The presentation will enable a discussion of the challenges associated with developing and justifying meaningful specifications for oligonucleotide therapeutics.
Speaker(s)
Advances in Analytical Approaches to Impurity Control for Commercial Oligonucleotides
Mike L. Webb
GlaxoSmithKline, United Kingdom
Vice President, API Chemistry & Analysis
Panelist
Mike L. Webb
GlaxoSmithKline, United Kingdom
Vice President, API Chemistry & Analysis
Rao V. Kambhampati, PhD
FDA, United States
Senior Chemist, CDER
René Thürmer, PhD
Federal Institute for Drugs and Medical Devices, Germany
Deputy Head of the Unit Pharmaceutical Biotechnology BfArM
Christoph Rosenbohm, PhD, MBA
Roche Innovation Center Copenhagen, Denmark
Vice President, Head of Discovery Operations
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