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Washington Court Hotel

Sep 25, 2013 8:00 AM - Sep 27, 2013 5:00 PM

525 New Jersey Avenue NW, Washington, DC 20001

DIA/FDA Oligonucleotide-based Therapeutics Conference

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Session 7B (CMC Track): CMC Strategies: Process Development, Validation and Control Strategies

Session Chair(s)

Anthony Scozzari

VP, Development Chemistry & Manufacturing

Ionis Pharmaceuticals, Inc., United States

An approach to process development based on platform and compound specific data will be presented. Critical process parameters of solid phase oligonucleotide synthesis will be discussed. The benefits of traditional and enhanced approaches to development will be presented. A proposed drug substance manufacturing process validation strategy will be discussed. Drug substance controls, including suggested specification limits based on platform data will be presented. Two presentations will be followed by a 30 minute panel discussion.

Speaker(s)

Daniel Capaldi, PhD

Process Development and Validation

Daniel Capaldi, PhD

Ionis Pharmaceuticals, Inc, United States

Vice President, Analytical and Process Development

Establishing Specification Limits for Phosphorothioate Oligonucleotides

Claus Rentel, PhD

Ionis Pharmaceuticals, Inc., United States

Vice President, Analytical Development and Quality Control

Daniel Capaldi, PhD

Panelist

Daniel Capaldi, PhD

Ionis Pharmaceuticals, Inc, United States

Vice President, Analytical and Process Development

Panelist

Claus Rentel, PhD

Ionis Pharmaceuticals, Inc., United States

Vice President, Analytical Development and Quality Control

Ramesh Raghavachari, PhD

Panelist

Ramesh Raghavachari, PhD

FDA, United States

Chief, Branch I, DPMA1, OLDP, OPQ, CDER

Panelist

Fran Wincott, PhD

United States

President

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