Biological Controls (OBK)
We provide comprehensive pharmaceutical services in accordance with the principles of good manufacturing practice (GMP) and of good laboratory practice (GLP) (http://www.prekliniky.cz/en/).
We offer to the business partners the performance of biological studies for their research and development goals within the GMP/GLP regimen and in accordance with the OECD methods:
- implementation of customized experiments for external authority
- quality control of manufacturing operations of medicinal products for human use
- toxicological studies and testing of commercially manufactured drugs (GLP, non-GLP studies) (http://www.prekliniky.cz/en/)
- pharmacological tests (determination of the efficacy of immunomodulators)
- toxicological tests (tests on specific and nonspecific harmlessness)
- pharmacopoeial tests (evidence of extraneous agents in viral vaccines and human cell substrate for the manufacture of human vaccines)
- testing of vaccines and allergens (methods for determining efficacy and safety)
- immunization of animals and blood products formulation, rabbit complement, guinea-pig complement
Our department is a GMP/GLP certified laboratory holding
- Certificate of GMP Compliance of a manufacturer issued by the State Institute for Drug Control (SIDC) for control laboratory (The control laboratory) in the range of biological production for quality control of medicinal products for human use and investigational medicinal products (Quality Control testing of human medicinal products)
- Certificate of GLP issued by the State Institute for Drug Control (SIDC) in the scope of activities Toxicological studies (The Test facility)
OBK, Institute of Physiology CAS holds Accreditation of user facility for usage of laboratory animals and Certification of a breeding and supplying facility for breeding of laboratory animals issued by the Central Commission for protection of animals of the Ministry of Agriculture (CCPA).