Developing streamlined, flexible cell therapy process workflows: from upstream to formulation and fill‑finish operations

Cell therapy manufacturing is evolving beyond manual open workflows, demanding closed, automated, and modular solutions to achieve scalability, consistency, and regulatory compliance. This article presents data from a series of closed, modular instrument platforms spanning cell separation, buffer exchange, gene delivery, gene editing, formulation, and filling, demonstrating their application across autologous CAR‑T cell, CAR‑iPSC, and CAR‑iNK cell manufacturing workflows.

Key data highlights include:

• Greater than 95% primary activated T cell recovery with maintained viability using the Gibco™ CTS™ Rotea™ Counterflow Centrifugation System across input volumes from 500 mL–20 L
• Gene knockout efficiencies of 90–95% and CAR knock‑in efficiencies of up to 48% for T cells, at manufacturing scale
• Volume accuracy with 2.4% error and viability retention of 96% from start to end of processing with the Gibco™ CTS™ Compleo™ Fill and Finish System across fill volumes from 0.5 mL–750 mL
• CTS Rotea system integration with Thermo Scientific™ Nunc™ Cell Factory™ System enabled closed automated harvest, wash and 5‑fold concentration of >1 × 10⁹ iPSCs
• iPSC‑to‑CAR‑iNK workflow demonstrating up to 30% anti mesothelin‑3 knock‑in efficiency in iPSCs and stable CAR expression in iNK cells with enhanced cytotoxicity against target cells

Together, these platforms demonstrate a practical path toward flexible, closed, end‑to‑end cell therapy manufacturing – from leukopak processing and genome engineering to final dose filling – applicable to autologous and smaller scale allogeneic processes.

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