Development concerns and validation of flow cytometry method in CMC research of cell therapy products
WANG Jing-yu
Wu Xue-ling
WEI Wei
Abstract：Due to the limited research methods and the particularity of the research samples,flow cytometry has become an important tool in the development of cell therapy products and plays an important role in many aspects of the CMC research of cell products.This paper discusses the concerns of quality control requirements,sample processing,the selection of fluorescence conjugated antibody,antibody titration,gating strategy in the development of flow cytometry method in the CMC research of cell therapy products,and the general principles of method validation for reference.
Keywords：flow cytometrycell therapy productfluorescence conjugated antibodyfluorescence compensationgating controlmethod validation
Publication Date：2025-03-30
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：5( 614-618 )