Sep
18
2019
On demand

A lens on the final formulation and fill & finish process: considerations for process automation and device development

The last place where you want your cell therapy manufacturing process to go wrong is the final key step: final formulation & fill/finish! In this webinar, we review this critical step of the process under the lens of moving from a manual system to automation for commercial production. What are the key considerations and parameters to review, the issues and complications that you need to address, and associated trade-offs when selecting a device/process. Finally, we explore the thought process in assessing in the development of a device to allow the migration from a manual process to an automated solution.

  • An overview of the final formulation and fill & finish processing step for cell & gene therapies and associated key considerations
  • The pros and cons of manual and automated processing in this critical step and how these change over the development lifecycle of the product
  • Obtain a perspective with the lens from both early stage and commercial manufacturing and how that factors into the development of an automated solution
  • The trade-offs in the development of a process and the technology to execute that process

Kyle Massey
Systems Engineer at Terumo BCT
Michael Covington
Vice President, Regulatory CMC at Orchard Therapeutics
Dalip Sethi
Manager, Senior Scientist at Terumo BCT

SPEAKERS

Kyle Massey
Systems Engineer at Terumo BCT
Michael Covington
Vice President, Regulatory CMC at Orchard Therapeutics
Dalip Sethi
Manager, Senior Scientist at Terumo BCT

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