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Session 9 Track 3: Innovative Manufacturing Approaches and Regulatory Implications
Session Chair(s)
Ramin Darvari, PhD, MS
Research Fellow
Pfizer Inc., United States
Rohit Tiwari, PhD
Senior Research Scientist, Global Regulatory Affairs-CMC
Eli Lilly & Company, United States
Continuous improvement in manufacturing of nucleic acid-based modalities requires innovative approaches, with the potential for introduction of new challenges, including the regulatory implications. This session will feature some of the recent innovative manufacturing approaches, along with a panel discussion to highlight the current regulatory landscape and identify prospects in closing potential gaps in understanding.
Learning Objective : At the conclusion of this session, participants should be able to:- Understand the critical risk factors associated with innovative manufacturing approaches
- Recognize and identify the relevant CMC challenges during the development stages
- Learn about developmental and regulatory considerations in mitigating the CMC risks
Speaker(s)
Oscillating Fluidized Bed Oligonucleotide Synthesizer: Reagents and Solvent Reuse in Solid Phase Oligonucleotide Synthesis
Representative Invited
Eli Lilly, United States
A Ligation Platform Approach to Enzymatic Oligonucleotide Assembly
Representative Invited
Glaxo Smith Kline, United States
Speaker
Representative Invited
Pfizer, Inc. , United States
Speaker
Representative Invited
Federal Institute for Drugs and Medical Devices, Germany
Speaker
Representative Invited
FDA, United States
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