Reallabor: Establishment of a real laboratory for the modular automated production of advanced therapy medicinal products (ATMPs)

The groundbreaking potential of ATMPs for use in medicine is undisputed. In ATMP-based immunotherapy for the treatment of cancer alone, hundreds of drugs are currently being investigated in clinical trials and the market is growing rapidly. Today’s largely-manual production of ATMPs will, however, lead to a bottleneck in the mid-term, so there is consequently a huge development requirement in this field. This bottleneck can only be avoided if future-oriented Industry 4.0 technologies are implemented in compliance with Good Manufacturing Practice (GMP) guidelines and integrated into ATMP production (digitization, automation, robotics, sensor technology).

In the Reallabor pilot project, initial demonstrators for automating the manufacturing process were designed using Fraunhofer's own cell therapeutic products under development as an example. In the future, these are to be implemented in digitally networked, automated, modular, scalable, and AI-supported production processes with the respective inline quality control, quality assurance, and documentation.

To this end, Fraunhofer IZI, Fraunhofer IME, and Fraunhofer ITMP have defined the workflows for manufacturing CAR-NK cell- and microbiota-associated therapeutics, produced the corresponding ATMPs, conducted functional tests and reviewed regulatory support.

Fraunhofer IPA and Fraunhofer IESE have developed physical and digital assistance systems at specific manufacturing interfaces as demonstrators for automation, process digitization, and quality assurance as well as for documentation in compliance with standards.

Expertise regarding the overall bioanalytical concept, product-specific offline/online sensor technology, the use of new types of materials and the integration of specific processes (i.e. inline analytics, miniaturized and highly integrated hardware modules for automated flow cytometry) was contributed to the project by Fraunhofer IMS, Fraunhofer IMM, Fraunhofer IBMT and Fraunhofer IZI-BB.