A Lens on the Final Formulation and Fill & Finish Process: Considerations for Process Automation and Device DevelopmentPublished: August 13, 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 will 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’ll 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
To Register for Wednesday 18th September: REGISTER
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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.
Geoffrey Uhl, Senior Engineering Manager, Cell Therapy Technologies, Terumo BCT
Geoff currently leads the product development efforts for the Cell Therapy Technologies portfolio at Terumo BCT. He previously led teams engaged in development of single-use disposable medical devices across several of Terumo BCT’s product lines. Prior to Terumo BCT, Geoff developed complex electromechanical systems in the fields of medical simulation and laboratory instrumentation. Throughout his 18-year career, Geoff has earned 3 US Patents for his contributions to product development efforts.
Hyalker L. Amaral, Senior Manager of Global Marketing, Cell Therapy Technologies, Terumo BCT
Hyalker is the Senior Manager of Global Marketing in Terumo BCT’s Cellular Therapy Technologies and is the commercial lead for new products Terumo BCT is developingin the cell therapy manufacturing space. Hyalker has spent 18 years in international pharmaceuticals in multiple commercial roles and therapy areas including ten years in the immunology space. Additionally, Hyalker has experience in all major regions globally including a 5 ½ year stint living in Europe (Hungary/Czech Republic, Switzerland and Spain). In the last seven years, Hyalker’s personal pursuits have incorporated running, primarily half-marathons, in different cities/countries.