Autologous Cell Therapy

Autologous cell therapies have seen increased growth since 2017, with the spotlight on the first FDA approved CAR-T immunotherapy followed by additional therapies gaining market approval in recent years. While autologous therapies have shown tremendous clinical success, scaling-out these therapies is a new challenge. The scale-out process is often complex and costly, requiring handling of multiple batches concurrently while maintaining the need for patient-specific customizations. This adds a significant risk profile to the manufacturing process. Close control of collection, shipping, storage, and culture conditions is needed to avoid contamination with other patient batches. Additionally, other supply chain considerations from chain of custody, chain of identity, quality and regulatory processes and much more need to be closely monitored to maintain the link between patient and sample.

As a preferred cell therapy CDMO, Catalent has supported a broad range of cell types for autologous manufacturing, ranging from CAR-Ts, TCRs, TILs, Treg, Mreg, MSCs, ESCs, Hematopoietic cells and much more. Our combined team experience of scientific know-how with scalable manufacturing have setup a variety of complex customer programs on a path of success. Our process efficiency methodologies such as Process Assessment and Manufacturing by Design across early development to late-stage clinical manufacturing is implemented with a future commercial mindset offering labor savings and swifter production cycles at scale. The use of process automation and integration of different manufacturing steps, while using a flexible, state-of the-art manufacturing infrastructure have further elevated the cost and labor efficiencies for innovator companies that partner with us.