Advanced Therapies: Innovations in CMC Conference

Solutions for CMC challenges in the development and commercialization of cell therapy, gene therapy, and gene editing products.

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Session 5c: Case Studies on Challenges for Cell-based Therapeutics

Session Chair(s)

Eliana Clark, PHD

Senior Vice President Technical Operations and Quality, Intellia Therapeutics, Inc., United States

Kirsten Messmer, PHD, RAC

Owner, KM Intel LLC, United States

Cell-based products use ‘living’ cells which creates additional challenges. These products face very specific CMC challenges due technology employed and need for maintaining cell product viability. This session will discuss case studies for 2-3 different gene edited products.

Learning Objective : At the conclusion of this session, participants should be able to:
Understand cell-based product specific CMC challenges during product development

Determine approaches to address the challenges to ensure regulatory compliance

Form strategies supporting development programs using cell-based therapies

Speaker(s)

Sunitha Lakshminarayanan, MBA, MS

Head and Executive Director of Cell Therapy Process Engineering, Bristol Myers Squibb, United States

Speaker

Richard Anderson, PHD, MSC

Senior Director, Fate Therapeutics, Inc., United States