Concentration And Reformulation Of Cellular Immunotherapies – A Major Downstream Processing Step

Cellular immunotherapies (e.g. CAR-T cells) are primarily used as an autologous therapy to treat cancer. As such, these therapies are currently generated in small batches for each patient. To generate enough modified cells for a single treatment, cells are expanded in volumes from 1-10 L. In the final step of downstream processing (DSP) for immunotherapies, cells cultured in large volumes must be concentrated and reformulated into smaller volumes (e.g. 20-100 mL) suitable for delivery to patients.

In this post, we will outline the key steps for concentration and reformulation and highlight specialized equipment needed for this critical unit operation. CCRM’s team has leveraged a partnership with GE Healthcare (GEHC) to create an innovative process based on modular and closed unit operations that can be staggered to produce multiple doses of an autologous therapy simultaneously.