Human Hepatocytes, Cryopreserved, Plateable and Interaction Qualified

Lonza's cryopreserved, plateable human hepatocytes, HUCPI, are characterized for 3 major mechanisms of DDI, transporter activity, enzyme activity, and enzyme gene induction potential. 

Additionally, the hepatocytes are tested and characterized for:  

• Inducibility of enzyme activity for CYP3A4, CYP2B6, and CYP1A2

• Inducibility of mRNA for CYP3A4, CYP2B6, CYP1A2, and CYP2C8 genes

• Actual rate of uptake or efflux for OATP1B1/3, OCT1/2, NTCP, and BSEP transporters

• Basal metabolism for 8 CYPs, SULT, UGT, and aldehyde oxidase

• Characterized for long-term culture potential (> 7 days)

• Characterized for spheroid formation potential

• Characterized for 96-well compatibility

Lonza's qualification methods for cryopreserved human hepatocytes are modeled after recommendations from the FDA publication In Vitro Metabolism and Transporter Mediated Drug-Drug Interaction Studies Guidance for Industry (2017)

Lonza's hepatocytes are isolated with donor-matched non-parenchymal (NPC), Kuppfer Cells, Stellate Cells, and Liver Sinusoidal Endothelial Cells.  All liver-derived cells have an optimized media system for thawing, plating, and maintenance. 

Lonza's scientists have developed optimized protocols for 3D growth in spheroid format for mono-cultures of hepatocytes and co-cultures of hepatocytes and NPCs.  This format provides a robust model for studying acute and chronic toxicities.