For autologous cell therapies, moving to large-scale manufacturing means scaling out rather than scaling up. That is, being able to repeat the same processes on a larger number of samples rather than producing a larger quantity of any one product.
What are the biggest issues related to scale-out? The speakers highlighted three: shifting from manual to automated processes; maintaining chain of custody (ensuring that the cells that came out of a patient are the same cells returned to that patient); and scalability of testing (minimizing the amount of product lost to testing and the time delay in product delivery).
Speakers from Agenus (formerly Antigenics), which is developing the Prophage series of autologous cancer vaccines, and Opexa Therapeutics, developers of autologous T-cell therapies, presented operational models for global delivery of autologous cell therapies and personalized vaccines that rely on one or a few centralized manufacturing facilities and decentralized, regional Centers of Excellence for collection of cell samples and delivery of the product to patients.
The aim of decentralizing cell collection and product delivery is to make the treatments more accessible to patients. At the same time companies need to ensure a rigorous chain of custody and to minimize the time from cell harvesting to delivery of a cell therapy.
Agenus’ Prophage vaccines (marketed as Oncophage® in Russia to treat renal cell carcinoma) are in Phase II trials in the U.S. to treat glioma (a type of brain tumor) and pediatric neurological tumors. Opexa’s Tovaxin® is comprised of patient-specific attenuated myelin reactive T cells intended to stimulate an immune response against pathogenic demyelinating T cells in patients with multiple sclerosis. The therapy has completed a Phase IIb study in patients with relapsing/remitting MS.