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Session 3A: CMC Track: Analytical Method Validation
Session Chair(s)
Kate Arnot, MSc
Regulatory CMC Director
AstraZeneca, United Kingdom
This session will highlight analytical method validation. The first presenter will discuss analytical method validation from the FDA perspective, with reference to recently published FDA guidance. The second presenter will discuss some of the challenges associated with developing and validating analytical methods for oligonucleotide-based therapeutics. The presentations will be followed by a 30-minute panel discussion. Discussion topics may include:
• Platform approaches to analytical method validation
• Validation of identity, assay and impurity tests with regard to specificity System suitability requirements
• Challenges associated with using orthogonal purity methods
Speaker(s)
New FDA Guideline on Analytical Method Validation
Lucinda F. Buhse, PhD
FDA, United States
Director, Office of Surveillance, OPQ, CDER
Validation of Analytical Methods for Oligonucleotide Therapeutics
Claus Rentel, PhD
Ionis Pharmaceuticals, Inc., United States
Vice President, Analytical Development and Quality Control
Q&A Panel Discussion (Joining the Speakers)
G. Susan Srivatsa, PhD
ElixinPharma, United States
President
Matthias Kretschmer, PhD
Alnylam Pharmaceuticals, United States
Senior Director, Analytical Development
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