How TC BioPharma Reduced 200 Manufacturing Steps and Improved Products

How TC BioPharma Reduced 200 Manufacturing Steps and Improved Products ...

TC BioPharm eliminated roughly 200 steps from its allogeneic CAR-T biomanufacturing process, reducing hands-on manufacturing time by half, and reducing manufacturing costs to a fraction of the industry standard. Consequently, the company claims it can produce allogeneic gamma delta T cells for $300 to $500 per dose, significantly less than industry standards of $250,000 to $500,000.

Angela Scott, COO and co-founder of TC BioPharm, explains that the manufacturing process is linked to process development and benefits from a careful Quality-by-Design approach. Key points include the expansion of viable cells in a closed system, ongoing process monitoring, and risk mitigation strategies to reduce product variability.

Scott continues. In the autologous process, this was used to select the most powerful and prolific cells for expansion.

TC BioPharm utilizes a closed system of G-Rex flasks for cell expansion, a departure from traditional media bags. It also eliminates multiple connections and tubing, reducing the risk of contamination in connecting one receptacle to another, and eliminating numerous open-and-close manipulations, further reducing risks.

According to Scott, unwanted alpha-beta cells are labeled and removed using a CliniMACS system after we have expanded the gamma delta T cells population. Once we have established our final product containers, there are not many items of equipment that will provide a fully closed system.

She stresses that many respected companies list items of a kit that are GMP-compliant, but that you must ensure that they are properly GMP-compliant.

Scott says TC Biopharm minimizes the need to overhaul its manufacturing processes to anticipate future issues.

You may also like: