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Challenges and advantages of cell therapy manufacturing under Good Manufacturing Practices within the hospital setting.
Current Opinion in Biotechnology ( IF 7.7 ) Pub Date : 2020-07-11 , DOI: 10.1016/j.copbio.2020.05.005
Emanuela M Iancu 1 , Lana E Kandalaft 2
Affiliation  

Academic medicine serves to advance the scientific field and provide the highest quality of clinical care. This applies to cancer where there is a continuous unmet need for innovation. In the last decade, we have observed a significant development of commercial cell and gene-therapy products with a rapid growth of the industry. Hospital-based Good Manufacturing Practice (GMP) facilities which support primarily investigator-initiated clinical trials, are increasingly involved in interactions with industry. Although the missions of academic and commercial GMP facilities are different, both are bound by industry standards and often engage in technology transfer with industry partners. The successful set-up of an academic GMP facility requires striking a unique balance between commercial and academic priorities. Here we review the role of academic facilities in the development of cellular therapies with a focus on cancer immunotherapy and we highlight some of the most challenging operational aspects and point to potential solutions.

中文翻译:

在医院环境中按照“良好生产规范”进行细胞疗法生产的挑战和优势。

学术医学有助于推进科学领域,并提供最高质量的临床护理。这适用于不断满足创新需求的癌症。在过去的十年中,随着行业的快速发展,我们观察到了商用细胞和基因疗法产品的重大发展。基于医院的药品生产质量管理规范(GMP)设施(主要支持研究人员发起的临床试验)越来越多地与行业互动。尽管学术和商业GMP设施的任务有所不同,但两者均受行业标准约束,并且经常与行业合作伙伴进行技术转让。成功建立学术GMP设施需要在商业和学术优先事项之间取得独特的平衡。
更新日期:2020-07-11
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