ProCell for Patient Project to Develop Automated Production Unit for CAR-T Cell Therapies

The Robert-Bosch-Krankenhaus (RBK) in Stuttgart, the Universitätsklinikum Heidelberg and the Pharma Division of the Schwaebisch Hall-based special machine manufacturer Optima launched a project called "ProCell for Patient” that aims to develop a production system for CAR-T cell therapies.

Since 2017, five CAR-T cell products have been approved worldwide: Kymriah (Novartis), Yescarta and Tecartus (Kite/Gilead) and most recently Breyanzi (BMS) and Abecma (bluebird bio & BMS). There are around 1,200 further cell and gene therapies in the clinical pipeline. There are many university hospitals that have the expertise to manufacture CAR-T cell therapies, but their manufacturing processes originate in research, and they are therefore very manual and individualized, as well as costly and time consuming. Standardized and automated manufacturing at these clinics would lead to significant improvements in patient care.

"With the help of the ProCell for Patient system, it will probably be possible to reduce the amount of work, i.e. the number of hours that qualified staff today are spending on producing CAR-T cells by at least 50 percent," said Dr. Andrea Traube, who heads the project at Optima Pharma.

The ProCell for Patient system prototype is scheduled to be installed at the RBK in the summer of 2022. Roll-out to additional treatment centers and pharmaceutical contract developers and manufacturers (CDMOs/CMOs) is planned once testing and clinical trials have been completed.

Every year, over 430,000 people worldwide are diagnosed with leukemia. A further 500,000 patients suffer from non-Hodgkin's lymphoma worldwide. "Around a quarter of those patients who have already undergone treatment can benefit from treatment with CAR-T cells," says Prof. Dr. med. Michael Schmitt, who is regarded as a luminary in cellular immunotherapy. He heads up the GMP Core Facility at the Universitätsklinikum Heidelberg (UKHD). T-cells are genetically modified there. "We modify the cells so that they can subsequently attack cancer cells in the form of what are called killer cells."