Cytocentrics receives GLP certification
The Ministry for Health and Social Affairs of the state of Mecklenburg-Vorpommern awarded Cytocentrics AG the GLP certificate (Good Laboratory Practice) category 9. The biotechnology company is the first company in the new federal states of Germany with the authorization to carry out safety pharmacological tests on human ion channels in accordance with nationally and internationally recognized GLP guidelines.
Cytocentrics' customers are pharmaceutical companies that wish to avoid undesired side effects of pharmaceutical ingredients with human ion channels. This type of testing is required by the EMEA, the European regulatory authority for pharmaceutical drugs as well as its US counterpart, the FDA. These authorities' regulations stipulate that all non-clinical trials must be carried out under the GLP guidelines. "This serves to clarify side effects of substances before they are administered to people", explained Dr. Thomas Knott, board member and founder of Cytocentrics AG.
Cytocentrics AG is now authorized to perform one part of this pre-clinical testing specific for the effects of pharmaceutical substances on human ion channels as a service provider. "One unique aspect of our certification is that our automated patch clamp technology, called CytoPatch(TM), has been approved in addition to the conventional patch clamp method. This technology has been in-house at Cytocentrics," commented Dr. Knott.
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