GMP Facility for Advanced Therapies
Good Manufacturing Practice (GMP)
GMP is a system to ensure that medicinal products intended for human use are consistently produced and controlled according to appropriate quality standards. Swiss manufacturers of medicinal products must comply with international GMP standards set forth by the European Union (EU). These GMP standards are built on three pillars: 1) Pharmaceutical substances and products intended for human use are to be manufactured at sites that are adequately equipped and controlled, 2) the manufacturer has to demonstrate appropriate professional and technical knowledge that is provided by qualified staff, and 3) a Pharmaceutical Quality System (PQS) system needs to be established by the manufacturer.
The University Hospital Basel (USB) owns for the DBM a Swissmedic manufacturing license for two qualified laboratory sites: one GMP laboratory is situated at the 4th floor of the Zentrum für Lehre und Forschung (ZLF) and the second is operated at the Klinikum 2 USB as a part of the Labormedizin infrastructure. The current manufacturing license permits manufacture of advanced investigational medicinal products (ATMP) to be used in clinical trials for novel cell-, tissue- and gene therapy approaches.
Headed by Werner Krenger, PhD, the GMP Facility for Advanced Therapies is organized as a core facility of the DBM which offers as “Provider” central services to individual manufacturing research groups of the University of Basel and USB (“Users"). Delimitation agreements between Provider and User regulate activities and responsibilities. The final product is released for clinical use by the head of the core facility who certifies product batches in his function of a "Qualified Person" (QP).
Pharmaceutical Quality System and Staff
Both the core facility provider and the manufacturing group users are required to contribute to the implementation of a fully functional PQS necessary for the release of GMP-compliant medicinal products: The Quality Assurance (QA)-team encompasses five positions of the core facility staff. Additional GMP-relevant functions need to be provided be the manufacturers, including at minimum a Quality Control manager (QC), a Manufacturing Manager and a “Product Manager” (who is usually the principal investigator of a research group). Training of all staff (both core facility staff and research group staff) is organized by the core facility staff. Interested persons not currently affiliated with research groups working in the facility are also welcome to attend training sessions.
The two GMP laboratories, including their supporting utilities (computerized GMP monitoring systems, pharmaceutical gas supply systems and the laboratory instruments) are being routinely qualified and requalified in accordance with the requirements of GMP.
Currently, four research groups are using the GMP Facility for Advanced Therapies to manufacture four different ATMPs for use in clinical phase I and II trials, including cartilage for tissue therapy, and tumor-infiltrating lymphocytes, natural killer cells and virus-specific T cells for cellular therapies.
The facility offers the capacity for inclusion of additional teams upon their request. The DBM hopes that the availability of this core facility will further stimulate the transition of preclinical research into the study of exciting new investigational medicinal products.