Regulatory considerations for NK cells used in human immunotherapy applications

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.