One of the more interesting and novel cancer therapies is the genetic engineering of the patients T-cells, where the cells are modified to target a specific protein expression on the cancer cell. However, this is a paradigm shift in manufacturing moving from a centralized manufacturing (what we see today at large pharmaceutical companies, or 503B Outsourcing Facilities) to a patient point-of-care or decentralized manufacturing model.  In this case the CAR-T the cells are extracted, engineered, grown, and infused into the patient at the hospital or point-of-care facility.

See the below short video on how CAR-T Cell Therapy works.

Another paradigm shift in the case of CAR-T cell therapy which is derived from the patient’s own T-Cells is that the patient dose equals one product, and this represents an entire manufacturing batch.  This requires a new way of thinking about the regulatory requirements.  NIH published a good  article in 2015 that discusses a decentralized commercial manufacturing process.  As referenced in the NIH article, one solution is the CliniMACS Prodigy® a closed and automated platform.

Recently ZioPharm Oncology had their Phase 1 clinical trial placed on hold as FDA requested additional information concerning the CMC (Chemistry, Manufacturing, and Controls) section of their application.  I would anticipate/expect a learning curve as industry adopts and FDA regulates point-of-care manufacuring facilities.

One possible facility solution to point-of-care manufacturing was proposed by Biologics Modular where they provided a modular solution enabling T-cell collection, Manufacturing, QC testing, and infusion into the patient.  Although not specific to T-Cells the below video is is an example of Biologics Modular solution for a healthcare clinic and illustrates how the modular facilities may be configured and rapidly deployed to provide a modular point-of-care manufacturing solution.

As main stream pharma gets involved in personalized medicine and CAR T-cell therapy it will be interesting to see how they move from a very centralized manufacturing practice to a more fluid and flexible manufacturing with the factory of the future located at a hospital near you.

For questions about Biologics Modular click here, for questions about Performance Validation contact Rick Van Doel, or use our Contact Us page.