A Lens on the Final Formulation and Fill & Finish Process: Considerations for Process Automation and Device DevelopmentPublished: September 9, 2019
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, System Engineer, Cell Therapy Technologies, Terumo BCT
Kyle currently serves as technical and project lead for development of Cell Therapy Technologies at Terumo BCT. Throughout his seven-year career, he has worked on various engineering and software development teams at Terumo BCT to develop cellular therapy and automated blood collection devices.
Michael Covington ,Vice President, Regulatory CMC, Orchard Therapeutics
Michael is an expert in the human therapeutic biotechnology and biologics fields in areas including Regulatory Affairs, Quality, Compliance, and Manufacturing. He has provided leadership for companies developing recombinant proteins, monoclonal antibodies, cellular, and genetic therapies primarily for the treatment of Cancer and Rare Diseases including Amgen, Dendreon, and Juno Therapeutics. Michael is currently the Vice President of Regulatory CMC for Orchard Therapeutics.
Dalip Sethi, PhD, Manager, Senior Scientist, Cell Therapy Technologies, Terumo BCT
Dalip currently serves as the scientific development lead for the Cell Therapy Technologies portfolio at Terumo BCT. He holds a doctorate degree and conducted post-doctoral studies at Thomas Jefferson University, School of Medicine. Prior to Terumo BCT, Dalip was engaged in the development of technologies & methods for use in autologous cell therapy applications. Throughout his career, Dalip has authored multiple scientific publications and is a co-inventor on several patents & patent applications.