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2020 ISPE Biopharmaceutical Manufacturing Virtual Conference


Cell and Gene Therapy CMC and Manufacturing: Ensuring the Analysis, Production and Quality


Jun 1, 2020 2:30pm ‐ Jun 1, 2020 4:00pm

Description

Robust and cost-effective viral vector characterization and manufacturing presents a core challenge in the commercialization of gene therapies with pressure mounting on CMC, analytical and manufacturing teams to keep up with accelerated development times and cost pressures. Gene Therapy CMC and Manufacturing examines the critical challenges facing the production, characterization and quality control of vector-based gene therapies, with dedicated sessions on rapid CMC development, product and process characterization, upstream and downstream bioprocessing and considerations for large-scale manufacturing.

Moderator(s):

Speaker(s):

  • James Warren, VP, Pharmaceutical Development, Ultragenyx Pharmaceutical Inc.
  • Kathleen Francissen, PhD, Senior Director, Pharma Technical Regulatory, Genentech, A Member of the Roche Group
  • Monica Commerford, PhD, Manager of Regulatory Affairs, Brammer Bio

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