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Statement of GLP compliance granted to PRIMACYT GmbH, Schwerin24.01.2007 - (idw) ScanBalt
PRIMACYT Cell Culture Technology GmbH is the first GLP (Good Laboratory Praxis) certified company in Mecklenburg-Vorpommern, Germany. The official statement of GLP compliance was granted by the national authorities after an audit was held on December, 18th, 2006.
Unlike the DIN or ISO-Norm, which focuses on the German or European market, GLP is the only quality control standard approved worldwide by international authorities with regard to the accreditation of new drugs. It is therefore a key prerequisite for collaboration with global pharmaceutical and biotech companies. Being in strict compliance to the guidelines of good laboratory practice, PRIMACYT will now be able to provide test reports appropriate for use at the drug regulatory agencies not only in Germany but also in other important markets like the United States or Europe.
PRIMACYT is a contract research organization offering in vitro technology services and cell culture products for pharmaceutical industry and biotech companies.
With HEPAC2 the young biotech start up company has developed a long-term human hepatocyte culture system, that is used as a biosensor for the analysis of drugs, food additives, and chemicals.
HEPAC2 allows the repetitive application of drugs within one cell culture. Thereby, hepatocytes may not only be used for one experiment, but instead can be "recycled" and may be used after a recovery period for a second, a third or even a fourth round of experiments. Thus, the system is designed to reduce the number of animal experiments and to reduce the costs of preclinical studies.
Primacyt GmbH is member of BioCon Valley Mecklenburg-Vorpommern e.V.
PRIMACYT Cell Culture Technology GmbH
Dr. Dieter Runge
Hagenower Str. 73
Cellular phone +49-(0)151-1703-1990
BioCon Valley Initiative
- Life Science in Mecklenburg-Vorpommern
Dr. Heinrich Cuypers
Fon +49 (0)3834 515 108
Fax +49 (0)3834 515 102
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