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

主题 429 - CCAL：细胞治疗处理全自动系统 (SBIR)

• 批准号: 10508622
• 负责人: EMILIO BARBERA-GUILLEM
• 金额: $ 39.33万
• 依托单位: CELARTIA, INC
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-13 至 2022-06-12
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10508622
• 关键词: Autologous; Automation; Bioreactors; CAR T cell therapy; Cell Therapy; Cells; Clinical; Decentralization; Decontamination; Dose; Endotoxins; Engineering; Evaluation; Exhibits; Human; Intervention; Manuals; Monitor; Patients; Performance; Preparation; Process; Production; Sampling; Small Business Innovation Research Grant; Speed; Sterility; System; Technology; Transfection; bioprocess; chimeric antigen receptor T cells; cost; flexibility; improved; innovation; instrumentation; point of care; protocol development; prototype

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.

在这个项目中，Celartia，Inc.将提供一个紧凑，高容量，全自动化，细胞治疗生产系统，适合GMP要求。该系统被命名为CCAL，采用模块化工艺方法，并利用Petaka G3生物反应器的技术进步，在单个工作站内实现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实用性，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动过程生产的质量相同的工程化CAR T细胞剂量。这些批次将是活的、无内毒素的、具有完整功能的，并且含有具有临床意义的剂量。 该项目的大部分内容需要将专有的，精确的自动化技术应用于创新的 生物处理仪器可自动化每个重要的生产步骤，包括： 净化、靶细胞纯化、转染/转导、孵育、生物过程监测细胞浓缩和洗涤、终产物制备和释放标准评估，每个步骤均在连续无菌层流下进行。这一创新将提供大规模的灵活、分散、自动化、即时生产，同时生产的边际成本极小。通过加快交付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。