The Ministry for Health and Social Affairs of the state of Mecklenburg-Vorpommern awarded Cytocentrics the GLP certificate (good laboratory practice) category 9 on 3 April 2008
The Rostock-based biotechnology company is the first company in the new federal states of Germany with the authorisation to carry out safety pharmacological tests on human ion channels in accordance with nationally and internationally recognised 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 Thomas Knott, board member and founder of Cytocentrics.
Cytocentrics is now authorised 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, has been approved in addition to the conventional patch clamp method.
"This technology has been in-house at Cytocentrics," commented Knott.
GLP is a quality assurance system which governs the planning, carrying out and monitoring of non-clinical safety tests.
The strict GLP standard was originally introduced to enable mutual acceptance of the results of studies performed by different laboratories in different countries.
The carrying out of studies, as well as the documentation and archiving of the resulting data are strictly regulated.
The quality system also has strict requirements concerning employee training and technical equipment.
Authorities carry out regular audits of companies to verify the implementation of the GLP quality standard.
