Andreas Traube, Fraunhofer IPA, Stuttgart

ATMPs in general and cell and gene therapies in particular offer enormous potential for treating and curing serious complex diseases. However, the manufacturing processes and quality assurance of sterile products are considerably more complex than for conventional biopharmaceutical drugs. Today's manufacturing processes are highly manual and require a very complex infrastructure. Automated systems for the GMP production of ATMPs are often monolithic and are therefore very inflexible and cannot be scaled efficiently. For these reasons, the costs of production are extremely high today. At the same time, many products have limitations in terms of process stability and product quality. There are thousands of promising ATMPs in the preclinical phase.

The lecture will present key technologies that allow efficient scaling and flexibilization of decentralized production. Based on shell-like modular mini-factories, a so-called farming matrix can be built, which can be operated in a decentralized, safe and cost-efficient manner.

The lecture will present the prototypes developed at Fraunhofer IPA.