Cell Therapy Laboratory and Quality Control Laboratory
The Cell Therapy Laboratory and the Quality Control Laboratory of Medyag Ltd. operate on our Debrecen headquarters.
Our mission is to incorporate state-of-the-art cell therapies, which are partly or not at all available even in developed countries, into national clinical practices.
The laboratory in Debrecen was founded in May 2003 as the result of an extensive research and development activity with the Medical and Health Science Center, University of Debrecen (DE OEC).
The Clinical Center, University of Debrecen (DE KK) plays a fundamental role in introducing basic and targeted applied research results into clinical practices. Due to its extensive experience in medicine and education as well as its international relations, the Clinical Center has a pioneering role in national medical developments.
The Cell Therapy Center Ltd. has become one of the leading immune biological research and development laboratories in Hungary. The company has gained thorough experience in the field of manufacturing and quality assurance of a wide range of therapeutic products, which fulfill strict international requirements and standards. In order to manufacture suitable products, the rules of current Good Manufacturing Practice (GMP) and the FACT-JACIE guidelines have to be observed; moreover, suitably trained personnel, validated procedures, qualified and calibrated state-of-the-art equipment have to be continuously provided.
The Quality Control Laboratory is accredited by the National Accreditation Board, accreditation no: NAT-1-1692/2012.
Technical testing laboratory
The Quality Control Laboratory of the Cell Therapy Center Ltd. operates at the Budaörs premises of the company. Its main profile includes the onsite examination of pharmaceutical and chemical industry equipment as well as the onsite or laboratory calibration of measuring instruments. Our temperature and humidity mapping tests are accredited by the National Accreditation Board, accreditation no: NAT-1-0870/2015.
The laboratory operates a quality management system in accordance with the MSZ EN ISO/IEC 17025:2005 standard.
The personnel of the laboratory have gained extensive experience in the field of clean room tests (that cannot be categorized as mapping tests), that is, tests of laminar airflow boxes and HVAC systems.
Apart from tests and calibrations, the laboratory also offers the following services: qualification of measuring instruments, validation consultancy, supervision of quality management systems (GMP, ISO 17025, ISO 9001), supervision of biological safety laboratory (BSL) systems, training activities (qualification, calibration, development of quality management systems).
