Page 52 - SaxoCell Annual Report22/23

SYSTEMS

The goal of SaxoCellSYSTEMS is to build an automation platform for the production of cell
therapeutics (ATMPs) in the SaxoCell cluster.

Project lead: Stephan Fricke & Ulrich Blache

Partners: Fraunhofer IZI, ICCAS University of Leipzig, TUD Dresden University of Technology

SaxoCellSYSTEMS has the long-term goal of establishing an automation platform for the
manufacturing of cell products (ATMPs) of the SaxoCell cluster. In the current implementation
phase (2021-2024), the focus is on the development of a concept for automated manufacturing of
cell therapeutics, the evaluation of artificial intelligence (AI) methods for automation, the
integration of intelligent quality management and the development of new quality controls.
Furthermore, the consortium is developing GMP training concepts.

Among the results achieved so far are the mapping of GMP-compliant automation challenges, the
development of a training concept for GMP personnel, the creation of a competence atlas, the
publication and submission of scientific papers, and the clarification of system architecture
aspects.

Currently, the use case for the production of Mesenchymal Stromal Cells (MSCs) in particular is
being considered in close cooperation with the SaxoCell project MSC-PreStiGe. In this context, a
generic thinking and design model was formulated and critical digital interfaces were identified. In
addition, progress was made in developing AI models for determining confluence and analyzing
impedance measurements of MSCs in 3D cultures. Monitoring parameter requirements for the
MSCs expansion use case were determined and appropriate cell culture models were identified.
Microcavity arrays for 3D cell culture models were fabricated and initial test measurements were
performed.

The creation of GMP training modules has taken place and a collaboration with SaxoCell Hub to use
the education portal has been established.

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