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ATMPs/C&GT - Projects & Commercial Manufacturing


Jun 29, 2022 8:45am ‐ Jun 29, 2022 10:15am



Credits: None available.

Description

This session is not being live streamed but will be available on-demand within 3 weeks of the conference end date. An email notification will be sent out when the content is available.

The quality attributes of advanced therapy medicinal products (ATMPs) that correlate with safety and efficacy in patients are determined not only by manufacturing process inputs such as starting and raw materials, but also by how the manufacturing process itself is designed and controlled. To ensure regulatory compliance, the manufacturing process should therefore be developed based on thorough characterization of the ATMP during all stages of process and analytical development; this ensures that the critical quality attributes that correlate with safety and efficacy are identified and that their specifications can be met during routine manufacturing.  This session will include presentations exemplifying design, manufacturing and operation of the commercial manufacturing of medicinal products.

Speaker(s):

  • Richard Denk, Senior Consultant Aseptic Processing & Containment, SKAN AG
  • Robert Dream, PE, CPIP, PhD, Managing Director, HDR COMPANY LLC
  • Robert F. Flynn, Principal Engineer, Genzyme A Sanofi Company
  • Ian Gaudet, PhD, Senior Director and Site Head, San Jose Cell Manufacturing Facility, Miltenyi Biotec
  • Jordan N. Hjelmquist, Program Manager - Commercial Gene Therapy, Pfizer
  • Evan Lamb, Product Specialist, ATMP Applications, Skan US
  • Jeffery N. Odum, CPIP, Practice Leader: ATMPs & Biologics, Genesis AEC

Credits

Credits: None available.

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