TOPIC 429 - CCAL: FULLY AUTOMATED SYSTEM FOR CELL THERAPY PROCESSING (SBIR)

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In this project, Celartia, Inc. will deliver a compact, high-capacity, fully-automated, cell therapy production system, suitable for GMP requirements. Designated the CCAL, this system features a modular process approach and exploits the technological advancements of the Petaka G3 bioreactor to allow massive parallel sample processing (multiplexing), within a single workstation, and without human intervention. To demonstrate its value and commercial utility, the prototype CCAL will simultaneously process multiple autologous samples to produce engineered CAR T-cell doses of a quality equal to those currently produced using slow and expensive manual processes. These batches will be viable, endotoxin-free, with full functionality, and contain a clinically-meaningful dose. The bulk of the project entails applying proprietary, precision, automation technology to the innovative bioprocessing instrumentation to automate every essential production step, including: incoming sample decontamination, target cell purification, transfection/transduction, incubation, bioprocess monitoring cell concentration and washing, preparation of end product, and release criteria evaluation, with every step carried out under continuous sterile laminar flow. This innovation will deliver flexible, decentralized, automated, point-of-care production at large scale while with a miniscule marginal cost of production. By speeding delivery and reducing the cost of goods, this innovation will improve patient access to these important cell therapies.