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Cells4research is a company providing services in medical biotechnology, coordinating the supply of test systems based on human liver cells and stem cells to pharmaceutical companies and academic research institutes for use in pre-clinical research to evaluate the safety of new potential drugs.

Cells4research can supply the following test systems:

  • Human hepatocytes in suspension and plated
  • Human liver slices (200 - 250 µm or as specified)
  • Bank of human liver S9 fractions and microsomes (n=50+), characterised as follows:
    • CYP1A2
    • CYP3A4
    • GST
    • EROC
    • ECOD
    • PROD
    • EROD
  • Bank of human liver samples (n=50+)
  • Bank of human liver RNA (n=50+)  

Note:

  1. All test systems are accompanied by anonymous donor demographics and pathological data
  2. Each donor, where possible, is tested by an FDA approved method and found non-reactive for antibodies to HIV-I and hepatitis-B & C. Where donor testing is not possible, individual cell strains are tested for the presence of viral DNA from HIV-I and hepatitis-B & C by PCR. *

Please contact us for availability and service fees.

Our sources of hepatic tissue are donated human livers that are not suitable for transplantation and donated surplus tissue from partial therapeutic hepatectomies.

The research applications of human liver cells in drug discovery and development are many:

1. Drug Metabolism
Human liver cells, and processed material such as microsomes and hepatocytes, are essential for gathering information about the metabolism of potential new drugs before they are tested in living subjects. Such information speeds up the process of discovery and development of better and safer drugs to treat every imaginable disease, from the common cold to cancer and AIDS. With this knowledge, scientists are able to focus their efforts on those drug candidates that are most likely to be safe and effective. Doing these studies with human tissue also reduces the number of laboratory animals that are sacrificed for research. In addition, the enzymes that metabolize some drugs are not present in some people. Pharmaceutical companies try to avoid developing drugs that are metabolized by those enzymes due to the wide variation in effectiveness of those drugs in different people.

2. Drug-drug interactions
Many people, particularly the elderly, are required to take a wide variety of medications on a routine basis and must be very careful to avoid certain combinations of drugs which can interact to cause unwanted side effects and/or toxicity. A drug that enhances or inhibits the metabolism of another drug could reduce its effectiveness or cause toxic side effects, respectively. Researchers use human liver tissue to investigate potential interactions between different drugs; in particular, potential interactions between new drug candidates and other drugs that are likely to be administered with them are probed. The results help determine whether specific clinical trials are needed to address drug interactions and enable doctors to avoid potentially dangerous combinations of drugs.

3. Drug toxicity
The liver is the major site of conversion of drugs and other chemicals into products (metabolites) that are excreted. However, in some cases the metabolites may be toxic to the body. The use of fresh liver cells enables pharmaceutical researchers to investigate the possibility of toxicity due to a drug or one of its metabolites at an early stage in the drug development process. With this knowledge, they can focus their efforts on drugs that are likely to be safe when they are eventually tested in people. This not only speeds up the process of drug development, but also reduces the number of laboratory animals that are used.

4. Species selection for toxicity studies
One of the many government requirements that must be satisfied prior to testing a potential new drug in humans is that the drug candidate must be tested on laboratory animals. Critics point out that animal studies do not necessarily predict what will happen in people, because of basic physiological differences between different species. Some of these concerns can be eliminated through the use of human liver cells, by comparing the metabolism of a drug candidate in human liver vs. liver cells from various animal species. The results enable researchers to select the most appropriate animal species for pre-clinical testing of new drugs.

5. Reducing the use of laboratory animals
Prior to the availability of human liver cells for studies of drug metabolism, drug toxicity and drug-drug interactions, it was necessary to use cells obtained from laboratory animals such as rats, mice and dogs. Although animal liver differs in many important ways from human liver, some studies were needed and there was no alternative. Now that human liver cells is available for research, researchers can study a more relevant experimental model while simultaneously using fewer animals. 

6. Advantages of human liver cells vs. animal liver cells
A large number of studies of drug metabolism, drug toxicity and drug-drug interactions have demonstrated that many drugs are handled differently by animals than humans and/or have different effects on animals than humans. In some cases, there are more similarities than differences, but in others the differences are dramatic. It is nearly impossible to predict beforehand whether a potential new drug will be metabolized in the same way and to the same degree by a laboratory animal and by humans. The availability of human liver cells, therefore, is crucial to the process of discovering and developing safe and effective new drugs.

Further reading:

Gebhardt R, Hengstler JG et al: New hepatocyte in vitro systems for drug metabolism: metabolic capacity and recommendations for application in basic research and drug development, standard operation procedures (2003)

Brandon EFA et al: An update on in vitro test methods in human hepatic drug biotransformation research (2003)

* These test systems are for research use only. Each donor, where possible, is tested by an FDA approved method and found non-reactive for antibodies to HIV-I and hepatitis-B & C. Where donor testing is not possible, individual cell strains are tested for the presence of viral DNA from HIV-I and hepatitis-B & C by PCR. Please note that no known test method can offer complete assurance the viruses that cause HIV-I and hepatitis-B & C are absent. All human based products should be handled at BSL-2 levels ( Biosafety Level 2) or higher as recommended for any human sourced material as recommended in the CDC-NIH Manual, “ Biosafety in Microbiological and Biomedical Laboratories”, 1988.

© 2012   Cells4research AB