Solid CAR-T: Modular mini-factories for autonomous CAR-T cell production

Personalized medicine is a new and revolutionary milestone in the treatment of complex diseases that were previously incurable. The possibilities range from personalized implants to drugs specifically tailored to a patient. The products and the processes required to manufacture them are heterogeneous. Today's production processes are mostly manual and therefore time-consuming and expensive. Quality control and the prognosis of therapeutic success are also extremely complex.

CAR-T cell therapies in the personalized treatment of patients with acute leukemia and lymphoma are a turning point in cancer medicine. However, not only is the complex production process a challenge, but also the so far less effective use of these cells in solid tumors. The project aims at enabling decentralized facilities such as university hospitals to produce high-quality CAR-T cells in a standardized form with the aid of a “mini-factory”. Based on a selected tumor scenario (bile duct carcinoma), the time-consuming laboratory processes required to produce a targeted, personalized immune cell therapy will be replicated in an automated process under GMP conditions using a miniature factory. The interdisciplinary consortium (IPA, UKT, NMI) covers the entire chain from process development through automated and digitized manufacturing technology to in-line quality control and new in vitro test methods for demonstrating efficacy.

By standardizing the manufacturing technology, academic institutions will be able to produce a wide range of cell preparations significantly faster, cheaper and in a higher quality than the market has been able to achieve so far.