Needle to needle robot-assisted manufacture of cell therapy products.
Needle to needle robot-assisted manufacture of cell therapy products.
复制标题
DOI：
10.1002/btm2.10387
复制
发表时间：
2022-09
影响因子：
7.4
通讯作者：
Murphy, J. Mary
中科院分区：
文献类型：
--
作者：
Ochs, Jelena;Hanga, Mariana P.;Shaw, Georgina;Duffy, Niamh;Kulik, Michael;Tissin, Nokilaj;Reibert, Daniel;Biermann, Ferdinand;Moutsatsou, Panagiota;Ratnayake, Shibani;Nienow, Alvin;Koenig, Niels;Schmitt, Robert;Rafiq, Qasim;Hewitt, Christopher J.;Barry, Frank;Murphy, J. Mary
先进的治疗药物产品(ATMP)已经成为治疗无法治疗的疾病的新疗法，产生了对大量高质量、符合临床要求的GMP细胞的需求，以取代昂贵、高风险和有限规模的人工扩张过程。我们介绍了一种全自动化、机器人辅助的平台的设计，该平台结合了多升搅拌槽生物反应器的使用，用于可扩展地生产贴壁的人类干细胞。该设计解决了针对针封闭过程，将自动骨髓收集、细胞分离、扩增和收集整合到冷冻箱中，供患者使用。AUTOSTEM是一种模块化、适应性强、完全封闭的系统，确保操作员不会与生物材料直接交互；所有命令都通过图形界面执行。在封闭式平台内，源材料的播种、过程监控、进料、取样、收获和冷冻保存都是自动化的，包括两个可实现开放和封闭过程的洁净室。基于人骨髓间充质干细胞在微载体上扩增的生物过程被用于概念验证。利用同等的培养参数，AUTOSTEM机器人辅助平台成功地进行了升规模的细胞扩增，产生了与人工生产相当的结果，同时保持了细胞质量的后处理。
Advanced therapeutic medicinal products (ATMPs) have emerged as novel therapies for untreatable diseases, generating the need for large volumes of high‐quality, clinically‐compliant GMP cells to replace costly, high‐risk and limited scale manual expansion processes. We present the design of a fully automated, robot‐assisted platform incorporating the use of multiliter stirred tank bioreactors for scalable production of adherent human stem cells. The design addresses a needle‐to‐needle closed process incorporating automated bone marrow collection, cell isolation, expansion, and collection into cryovials for patient delivery. AUTOSTEM, a modular, adaptable, fully closed system ensures no direct operator interaction with biological material; all commands are performed through a graphic interface. Seeding of source material, process monitoring, feeding, sampling, harvesting and cryopreservation are automated within the closed platform, comprising two clean room levels enabling both open and closed processes. A bioprocess based on human MSCs expanded on microcarriers was used for proof of concept. Utilizing equivalent culture parameters, the AUTOSTEM robot‐assisted platform successfully performed cell expansion at the liter scale, generating results comparable to manual production, while maintaining cell quality postprocessing.
登录
查看更多内容
影响因子：
3.8
作者：
Rafiq, Qasim A.;Hanga, Mariana P.;Hewitt, Christopher J.
通讯作者：
Hewitt, Christopher J.
影响因子：
1.2
作者：
Fabian, Zsolt;Ramadurai, Sivaramakrishnan;Barry, Frank
通讯作者：
Barry, Frank
影响因子：
4.3
作者：
Qie, Shuo;Liang, Dongming;Sang, Nianli
通讯作者：
Sang, Nianli
影响因子：
3.8
作者：
Hanga, Mariana Petronela;de la Raga, Fritz Anthony;Wall, Ivan
通讯作者：
Wall, Ivan
DOI：
10.1016/b978-0-444-63265-4.00003-0
发表时间：
2016-01-01
期刊：
STEM CELL MANUFACTURING
影响因子：
--
作者：
Nienow, A. W.;Coopman, K.;Hewitt, C. J.
通讯作者：
Hewitt, C. J.