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- W2989942008 abstract "Academic medicine, in general, serves a dual role in advancing the scientific field as well as providing the highest quality clinical care. In the last decade we have observed significant development of commercial cell and gene therapy products with rapid growth of the industry. Currently, hospital-based Good Manufacturing Practice (GMP) facilities, which are used to support primarily academic investigator-initiated clinical trials, are increasingly involved in interactions with industry.The purpose of this piece is to review the role of academic GMP facilities in development of cellular therapies. For the purpose of this review we will discuss manufacturing facilities located in hospitals or academic medical centers and compare them with commercial GMP facilities. 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. Therefore, successful operation of an academic GMP facility requires striking a unique balance between commercial and academic priorities. Finally, we highlight some of the most challenging aspects of academic GMP facility operation and point to potential solutions." @default.
- W2989942008 created "2019-12-05" @default.
- W2989942008 creator A5060763375 @default.
- W2989942008 creator A5073009158 @default.
- W2989942008 date "2019-11-28" @default.
- W2989942008 modified "2023-09-26" @default.
- W2989942008 title "Place of Academic GMP Facilities in Modern Cell Therapy" @default.
- W2989942008 cites W2898405715 @default.
- W2989942008 doi "https://doi.org/10.1007/978-1-0716-0203-4_21" @default.
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- W2989942008 hasPublicationYear "2019" @default.
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