A newly published white paper by DECHEMA explores the role of single-use technologies in the manufacturing of cell therapeutics. It is a topic of growing relevance as the biomanufacturing sector continues to attract significant investment in response to demand for innovative and affordable treatment options.
The paper focuses on how single-use technologies (SUTs) can meet the unique and demanding requirements of cell therapy production. Unlike conventional recombinant protein therapeutics, cell-based therapies offer potentially curative outcomes that can persist for years after treatment — but this promise comes with complexity. Maintaining a cell's mechanism of action and critical quality attributes throughout the manufacturing process is essential, and because these therapies are frequently used as last-resort interventions, both speed and safety of production can be a matter of patient survival.
SUTs — which today cover everything from storage and freezing to bioreactors, separation systems, mixing, filling, and tubing assemblies — are well positioned to address these challenges. Building on their proven track record in monoclonal antibody production, the white paper maps out suitable single-use systems and platforms for cell therapy manufacturing. The primary focus is on autologous CAR-T cell therapies, as well as autologous and allogeneic stem cell therapies using mesenchymal stem cells (MSCs) and induced pluripotent stem cells (iPSCs).
The paper will be of interest to a broad audience. Whether you are new to the field or an established player in biomanufacturing, it addresses practical aspects of process monitoring and quality control, and closes with a forward-looking section on emerging trends in SUT application as new cell therapies continue to advance through development and regulatory approval.
Download the white paper: https://dechema.de/Cell_Therapeutics-path-123211,124930.html
Bron: DECHEMA