Cryopreserved Human Hepatocytes

PRIMACYT is one of the pioneers in the development of advanced in vitro model systems. We are a leading company in the field of research of human and animal hepatocytes.

In 2008, we have received the Research Prize of the German Ministry of Nutrition, Agriculture and Consumer Protection for the “Development and validation of a serum-free, standardized and re-usable human hepatocyte culture system for the analysis of food, drugs and chemicals”.

PRIMACYT is approved by the European Commission as an EU Reference Laboratory for Alternatives to Animal Testing (EURL ECVAM) since 2013 and serves as a member of the laboratory network responsible for the method validation. 

Our colleagues are professionals and undergo continuous training in the preparation, isolation, and cryopreservation of hepatocytes in general, including related co-products, methods, and tools. We are a GLP certified laboratory since 2006.

Hepatotoxicity is a major cause for failure in drug development. For interpretation of hepatotoxicity data, it is important to understand potential interspecies differences in mechanisms that lead to drug toxicity. This includes

• drug uptake into the liver,
• biotransformation of the drug (Phase I and Phase II), and
• drug efflux from the liver

Primary Hepatocytes are best suited to demonstrate major tissue functions, such as ammonia detoxification or drug metabolism. Hepatocytes act as a living biological system. Cryopreserved hepatocytes are extremely well characterized and qualified for key applications: 

• Acute cytotoxicity assessment.
• Prediction of hepatic clearance
• Study donor dependent drug metabolism and induction. Plateable cryopreserved hepatocytes allow the evaluation of inter-individual variations in drug metabolism enzymes (DMEs) and response to inducers.
• Prequalified cryo-hepatocytes. Plateable cryopreserved hepatocytes can be obtained specially certified for studies of metabolism, induction or for transporter studies.
• Evaluation of repeated drug exposure. Plateable cryopreserved hepatocytes allow the evaluation of chronic exposition to drugs by the measurement of inflammatory signals.

Interspecies differences in expression and activities in transport proteins and biotransformation enzymes may result in different intra- and extrahepatic concentrations of the drug.

Albrecht W, et al.: Prediction of human drug-induced liver injury (DILI) in relation to oral doses and blood concentrations. Arch Toxicol. 2019, 93(6):1609-1637. doi: 10.1007/s00204-019-02492-9. Epub 2019 Jun 27

Ullrich A, et al.: Long-term cultures of primary human hepatocytes as an alternative to drug testing in animals.ALTEX. 2009, 26(4):295-302. doi: 10.14573/altex.2009.4.295.

Ullrich A, et al.: Use of a standardised and validated long-term human hepatocyte culture system for repetitive analyses of drugs: repeated administration of acetaminophen reduces albumin and urea secretion. ALTEX. 2007, 24(1):35-40. doi: 10.14573/altex.2007.1.35.

Dickens H, et al.: Anticancer drug cis-4-hyroxy-L-proline: Correlation of preclinical toxicology with clinical parameters of liver function. Mol Med Rep. 2008, 1(4):459-64.

Runge D, et al.: Serum-free, long-term cultures of human hepatocytes: Maintenance of cell morphology, transcription factors, and liver-specific functions. Biochem Biophys Res Commun. 2000, 269(1):46-53. doi: 10.1006/bbrc.2000.2215.

PRIMACYT offers cryopreserved human hepatocytes from single donors. Hepatocytes are cryopreserved directly after isolation. Each individual single donor is comprehensively tested for viability, plateability, for use in suspension assays and for Cytochrome P450/Phase I activities.

Ethical Compliance:
Human tissue donations are obtained with the inform consent from donors who undergo liver surgery. The tissue is removed during surgical operations and would otherwise be discarded as biological waste.

This info refers to the product data below:

• Inventory: Number of vials available as of date of last update. Availability of vials may have changed since that date by interim orders.
• Viability: Denotes post thaw results using the thawing protocol for hepatocytes.
• To print lot information, please select the print icon at the end of the lists below. For research use only. 
• Not intended for human or animal diagnostic or therapeutic use.

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This info refers to the product data below:

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Human hepatocytes information