The field of biomanufacturing has ained considerable attention in recent years, prompting greater investment in research and development to address the growing need for innovative, accessible, and affordable treatment options.
While recombinant protein therapeutics continue to dominate the market, cell-based therapies offer highly innovative, potentially curative treatment options that can persist for years post-infusion. However, these benefits come at a cost: therapeutic efficacy and overall resilience are closely tied to preserving the cells’ mechanism of action and critical quality attributes (CQAs) throughout manufacturing, placing individual unit operations at the center of product quality and clinical outcome. Furthermore, as these therapies are often used as last-resort interventions, particular emphasis must be placed on timely and safe production if patient survival is to be ensured.
Single-use technologies (SUTs) are well positioned to meet these requirements. Current SUT platforms span a wide range of applications, including storage, freezing, mixing, bioreactors, separation and filling systems, tubing assemblies, and even single-use needles.
Building on their well-established use in monoclonal antibody (mAb) production and on process flow diagrams for selected cell therapies, this paper presents suitable single-use systems and platforms for cell therapy manufacturing. The primary focus lies on autologous chimeric antigen receptor (CAR)-T cell therapies, as well as both autologous and allogeneic stem cell therapies based on mesenchymal stem cells (MSCs) and induced pluripotent stem cells (iPSCs).
Aimed at both newcomers and established stakeholders, this white paper also considers aspects of process monitoring and quality control in cell therapy production. The outlook section concludes with emerging trends in the application of SUTs, driven by the continued development and approval of new cell therapies.
DOI: 10.83455/202603SINGLEUSE
Veröffentlicht: März 2026