Article inspired by a Tapas and TECH Talks digital event. Fast Trak Centre for Advanced Therapeutic Cell Technologies (CATCT) team members shared peer-to-peer insights.
The therapeutic landscape has been evolving rapidly over the last few years, driven by discoveries in biologic modalities. The increase in levels of complexity, compared to the history of bioprocessing, raises some key challenges in terms of manufacturing these multicomponent or multifaceted therapy types.
As the industry moves from small molecules and natural products into biologics, engineered cells and viral vectors, and ultimately to the future where we're manufacturing restorative or regenerative therapies in their entirety, we have a tradeoff between the simplicity of the process and how cost effective it is.
Looking to the future, autologous and allogeneic therapies are likely to coexist. Both therapy types must be cost effective and efficient to produce, in order to reach the many people they will serve. A combination of new methods and technologies will be needed to achieve these goals. Among the choices are continuous manufacturing methods, new adherent cell technologies, and adapting cells to grow in suspension culture.
An ongoing collaboration between Cytiva and CCRM in the Fast Trak Centre for Advanced Therapeutic Cell Technologies (CATCT) aims to evaluate the options and bring them forward to further industrialize cell and gene therapy processes.
This article focuses on custom media development borne of this collaboration. Here we describe our process, highlighting a case study to remove serum from the expansion step of an autologous cell therapy. The challenge is to do so in a cost-effective manner without affecting cell performance.