Qualification of academic facilities for small-scale automated manufacture of autologous cell-based products
Qualification of academic facilities for small-scale automated manufacture of autologous cell-based products
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DOI：
10.2217/rme.14.47
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发表时间：
2014-01-01
影响因子：
2.7
通讯作者：
Williams, David J.
中科院分区：
文献类型：
--
作者：
Hourd, Paul;Chandra, Amit;Williams, David J.
学术中心、医院和小公司作为英国再生医学资产的典型开发环境，对自体细胞疗法的发展做出了重要贡献。通常缺乏适当的资金、质量保证传统或专业的监管专业知识，使无菌细胞加工设施符合GMP标准是一个重大挑战。具有自动化处理能力的新细胞疗法制造设施的资格认证是英国学术环境中的第一个此类设施，为在这些环境中符合GMP标准的自体细胞产品的小型自动化设施的资格鉴定提供了一个独特的示范。本文分享了我们对细胞疗法制造设施进行鉴定的经验，重点介绍了我们简化鉴定工作的方法、我们遇到的挑战、项目延误和效率低下，以及随后学到的经验教训。
Academic centers, hospitals and small companies, as typical development settings for UK regenerative medicine assets, are significant contributors to the development of autologous cell-based therapies. Often lacking the appropriate funding, quality assurance heritage or specialist regulatory expertise, qualifying aseptic cell processing facilities for GMP compliance is a significant challenge. The qualification of a new Cell Therapy Manufacturing Facility with automated processing capability, the first of its kind in a UK academic setting, provides a unique demonstrator for the qualification of small-scale, automated facilities for GMP-compliant manufacture of autologous cell-based products in these settings. This paper shares our experiences in qualifying the Cell Therapy Manufacturing Facility, focusing on our approach to streamlining the qualification effort, the challenges, project delays and inefficiencies we encountered, and the subsequent lessons learned.