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

在这个项目中，Celartia公司将提供一个紧凑、高容量、全自动的细胞治疗生产系统，符合GMP要求。该系统被命名为CCAL，其特点是采用模块化处理方法，并利用Petaka G3生物反应器的技术进步，在单个工作站内进行大规模并行样品处理（多路复用），无需人工干预。为了证明其价值和商业用途，原型CCAL将同时处理多个自体样本，以生产质量与目前使用缓慢而昂贵的手工工艺生产的CAR - t细胞剂量相当的工程化CAR - t细胞。这些批次将是可行的，无内毒素，具有完整的功能，并包含临床有意义的剂量。

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.