Biotechnology Colloquium: Bastian Nießing (Group Manager Automation in Life Sciences Fraunhofer IPT, Aachen)

Guest: Bastian Nießing (Group Manager Automation in Life Sciences Fraunhofer IPT, Aachen)

Title: The fully automated production of ATMPs: challenges, necessity and solutions

Abstract: One of the most successful immunotherapies to date is autologous Chimeric Antigen Receptor (CAR) T cell therapy. Since the first CAR T-cell therapy was approved by the FDA in 2017, manufacturing has evolved from open processing to closed, semi-automated devices that significantly reduce the risk of contamination. However, the integration of these semi-automated devices into a larger fully automated and digitized platform is rare. This also applies to other ATMPs (Advanced Therapy Medicinal Products) that are currently in clinical trials or have been approved.

Fully automated production of these ATMPs offers many advantages, e.g. human error in repetitive tasks such as pipetting liquids is avoided.Digital and fully continuous batch monitoring leads to greater product safety and a lower documentation burden for biological experts.The lack of approval and use of these drugs as first or second choice favors manual or semi-automated production.However, as soon as these drugs are taken as first or second choice, production needs can no longer be met and scalable automation of processes becomes inevitable.

There are still many hurdles to overcome.For one thing, many device manufacturers do not offer standardized interfaces for bidirectional communication.On the other hand, there is a lack of defined quality parameters and an understanding of how to manipulate these in a targeted manner in order to guarantee consistent product quality.

Industry 4.0 approaches to networked, adaptive production and the use of artificial intelligence can help to fully automate the laboratory and production of tomorrow.This will lead to reproducible processes and improved product quality as well as higher product availability.

For online participation, please contact m.hess@fz-juelich.de.