Establishment and evaluation of detection methods for process‐specific residual host cell protein and residual host cell DNA in biological preparation
Yixiao Tian,
Xinyue Wang,
Dongyan Shao
et al.
Abstract:To establish accurate detection methods of process‐specific Escherichia coli residual host cell protein (HCP) and residual host cell DNA (rcDNA) in recombinant biological preparations. Taking the purification process of GLP expressed by E. coli as a specific‐process model, the HCP of empty E. coli was intercepted to immunize mice and rabbits. Using IgG from immunized rabbits as the coating antibody and mouse immune serum as the second sandwich antibody, a process‐specific enzyme‐linked immunosorbent assay (ELI… Show more
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