Abstract
Translating cellular therapy from the laboratory to the clinic is a complicated process that involves scale-up of procedures to generate clinically relevant cell numbers, adaptation to reagents and equipment that are qualified for human use, establishing parameters of safety for reagents and equipment that are not already qualified for human use, codifying these processes into standards of practice and rules of conduct, and obtaining approval from regulatory bodies based on those codified standards and rules. As the laws and regulations that apply to cellular therapy will vary by time and geography, this chapter reviews some common key principles for the manufacturing of NK cells for human use that will need to be considered within the constraints of local policies and regulations.
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Acknowledgements
The author would like to acknowledge the staff of the GMP facility at MD Anderson Cancer Center for their excellent work in generating SOPs, CMCs, and CofAs for a large number of NK cell trials, and for sharing their tremendous knowledge in the regulatory aspects of cellular therapy trials.
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Lee, D.A. (2016). Regulatory Considerations for NK Cells Used in Human Immunotherapy Applications. In: Somanchi, S. (eds) Natural Killer Cells. Methods in Molecular Biology, vol 1441. Humana Press, New York, NY. https://doi.org/10.1007/978-1-4939-3684-7_29
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DOI: https://doi.org/10.1007/978-1-4939-3684-7_29
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