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

在这个项目中，Celartia，Inc.将提供一个紧凑、高容量、全自动化、适合GMP要求的细胞治疗生产系统。该系统被命名为CCAL，采用模块化工艺方法，利用Petaka G3生物反应器的技术进步，允许在单个工作站内进行大规模并行样品处理(多路传输)，而无需人工干预。为了展示其价值和商业用途，CCAL原型将同时处理多个自体样本，以生产质量与目前使用缓慢且昂贵的人工过程生产的质量相同的工程汽车T细胞剂量。这些批次将是可行的，不含内毒素，具有完整的功能，并包含具有临床意义的剂量。 该项目的主要内容是将专有的、精密的、自动化的技术应用于创新的 生物处理仪器使每个必要的生产步骤自动化，包括：来样 去污、靶细胞纯化、转染/转导、孵育、生物过程监测细胞浓度和洗涤、最终产品的制备和释放标准评估，每一步都在连续无菌层流下进行。这一创新将提供灵活、分散、自动化的大规模护理点生产，同时生产的边际成本极小。通过加快送货速度和降低商品成本，这项创新将改善患者获得这些重要细胞疗法的机会。

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.