Novel Methods for reducing CoGs in Autologous Processing
Organized by the Commercialization Committee
Chair: Thomas Brieva, Celgene
Juan Vera, MD, Assistant Professor, Center for Cell and Gene Therapy (CAGT), Department of Medicine, Baylor College of Medicine
Rosemary Drake, PhD, Chief Scientific Officer, TAP Biosystems
About the Webinar:
How cost effective is automation for autologous cell processing?
Presented by: Rosemary Drake
The labour intensive nature of cell processing and testing, together with management and tracking of individual patients' samples means that the cost of goods for autologous cell therapies can be high. Scaling up cell therapy manufacture requires significant investment in skilled staff and facilities, but this can be greater for autologous cell therapies since multiple clean room suites (with associated staffing) are required to ensure adequate segregation of many individual batches - effectively one batch per patient.
As autologous cell therapies come to market, there is a need to address these COG issues to ensure commercial success. Automation can significantly reduce manual processing, since it is now possible to automate many routine cell processing tasks with high reproducibility. Processes can be efficiently and accurately recorded, so saving considerably on the operator time spent on this task. Automation can potentially also reduce facilities investment cost (since fewer clean room suites are required). This webinar will discuss the contribution of automation to reducing COG for autologous cell therapy manufacture.
Optimized Manufacture of Antigen-specific T cells
Presented by: Juan Vera
Although the administration of ex-vivo activated and expanded antigen-specific cytotoxic T lymphocytes (CTLs) is being increasingly associated with promising clinical results, there are several limitations to the extension of this approach beyond the research arena. A major practical constraint is the complexity associated with producing large number of cells using conventional production methods. Traditionally our group and others have cultured virus- and tumor-directed T cells in 2cm2 wells of tissue culture treated 24-well plates. However, the restricted culture media:surface area ratio (1ml/cm2) required to facilitate gas diffusion, limits the supply of nutrients, which are rapidly consumed by proliferating T cells. Consequently, acidic pH and waste build-up rapidly impedes cell growth and survival. Therefore, the only alternative for cell propagation is frequent re-seeding and medium exchange which increases the frequency of manipulation required with a concomitant increase in the risk of contamination. Thus, we sought to optimize our antigen-specific T cell culture process which led us to evaluate a novel cell culture device (gas-permeable cultureware (G-Rex)), developed by Wilson Wolf Manufacturing, and in which O2 and CO2 are exchanged across a gas permeable silicone membrane at the base of the flask. Because gas exchange occurs from below, an increased depth of medium above is possible, providing more nutrients required by the cells while waste products are diluted, thus not adversely affecting cell growth. These optimal culture conditions provided by the G-Rex result in improved cell viability and increased final cell numbers without increasing the number of cell doublings, and decreasing the feeding frequency and the number of manipulations required.
This product is a downloadable PDF and provides a link to an mp4 video recording of the webinar.