Focusing on stem cells, immune cells (CAR-T/NK, etc.), and their derivatives, we build an evaluation end-loop from quality confirmation to functional validation. Utilizing multi-parameter flow cytometry and imaging technologies, we precisely identify cell phenotype, purity, and biological potency. Combined with advanced tracer technologies and highly clinically relevant experimental animal disease models, we visually elucidate cell homing (PK), persistence, and therapeutic efficacy (PD), ensuring products meet clinical entry standards.

(1) Source & Identity Confirmation (Positive markers: CD73, CD90, CD105, etc.).

(2) Product Purity & Viability (Purity, viability, mycoplasma, endotoxin, etc.).

(3) Function & Potency (Immunomodulatory function, paracrine function, in vitro/in vivo efficacy models, and in vivo homing tracing).

(4) Safety & Stability (Genetic stability, tumorigenicity/teratogenicity, stability).

(5) Formulation Quality Control (Final product testing, exosome products).

(1) Flow cytometry, microscopic imaging, immunofluorescence staining for cell characterization and phenotype identification.

(2) In vitro induction differentiation experiments, immunomodulatory activity assays, flow cytometry for biological function and potency assessment.

(3) PCR/qPCR, Limulus Amebocyte Lysate (LAL) assay, karyotype analysis, tumorigenicity assays for safety testing.

(4) ELISA, High-Performance Liquid Chromatography/Mass Spectrometry for purity and process residue analysis.

(5) Automated cell counters, CCK-8 for cell quality and survival rate analysis.

(6) In vivo imaging, immunohistochemistry/immunofluorescence, quantitative PCR, flow cytometry for cell homing tracing.