Large scale manufacture of human gallbladder epithelial cells to generate hepatocytes via chemical defined approach for clinical utility

We established a chemical defined and xeno-free approach to manufactured large-scale human gallbladder epithelial cells (hGBECS) in GMP condition for clinical utility. The cell products were characterization of growth ability, phenotype, frozen-thaw viability, genetic stability, bio-safety assessments for in vitro tests, and tumorigenicity assessments, acute toxicity experiments for in vivo tests.

We then established a protocol to generate functional hepatocytes from hGBECS (hGBECS-dHEPs). The derived hepatocytes exhibited typical liver function: glycogen storage, lipid synthesis, uptake ability, Albumin secretion, urea production and drug metabolism. Also, these cells were applied for tests of liver toxic drugs and anticancer drugs.