Cell Therapy

Example Testing manual for biomarker relate to Cell Therapy

Pharmacokinetics (PK): Car gene copy number (qPCR) / car number (FCM)

Pharmacodynamics (PD): cytokine detection (ELISA / MSD), etc

Immunogenicity (ADA): Anti-Drug Antibodies detection (ELISA / FCM)

Safety: RCL / RCR (qPCR / DDPCR), virus integration sites (NGS), etc

Cart cell type analysis: lymphocyte subsets (FCM)

Biomarker test: IHC / ELISA, etc

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