What you can expect from us
At TUMCells, we place great emphasis on the highest quality and safety. Our services and products meet stringent requirements to ensure the best possible protection for patients and participants in clinical trials. We not only comply with all legal regulations, but also consistently align ourselves with the latest scientific and technological advancements.
Our facility is regularly and successfully inspected by the Government of Upper Bavaria (ROB). The ROB grants us GMP certification and manufacturing authorization for our products. Furthermore, we support our customers with their PEI Scientific Advice. This consultation is essential before clinical trials begin, to ensure the safety and high quality of the products.
To ensure our high quality standards, we utilize a modern, electronically supported cGMP quality assurance system. This guarantees that our processes and products meet international standards. We are also JACIE accredited. This ensures high-quality laboratory practices in the fields of hematopoietic cell transplantation (HCT) and cellular therapy (CT).
What is JACIE?
JACIE stands for the Joint Accreditation Committee of ISCT and EBMT. ISCT (International Society for Cellular Therapy) and EBMT (European Group for Blood and Marrow Transplantation) are the two leading professional societies for hematopoietic stem cell transplantation in Europe. Certification is voluntary, but it is a means by which a center can demonstrate that it provides the required services in accordance with agreed quality standards and confirms that it operates an effective quality management system.
What regulatory requirements exist?
The manufacture of cell-based medicinal products and advanced therapy medicinal products (ATMPs) is subject to particularly stringent and complex requirements. These are based on the principles of Good Manufacturing Practice (GMP) and are legally regulated in the European Union (EU) and Germany to ensure safety, efficacy, and quality for patients.
Legal and regulatory framework:
- Medicines Act (AMG) and Ordinance on the Manufacture of Medicinal Products and Active Pharmaceutical Ingredients (AMWHV): In Germany, these laws form the basis for the regulations governing the manufacture of medicinal products, including cell-based therapies.
- EU GMP Guide: This guide from the European Commission specifies the concrete principles and rules of Good Manufacturing Practice that are binding for the production of medicinal products throughout the EU.
- Regulation (EC) No. 1394/2007 (ATMP Regulation): This EU regulation harmonizes the requirements for the authorization, monitoring, and pharmacovigilance of advanced therapies such as cell and gene therapies.
Any company and Institution- wishing to manufacture cell-based pharmaceuticals- requires a manufacturing license from the relevant authority. To obtain this license, compliance with all GMP regulations must be demonstrated. TUMCells already holds a manufacturing license for various products- for new products, this license must be extended.
Since working with living cells carries a high risk of contamination, specialized cleanrooms with strict hygiene and cleanliness standards are required. These cleanrooms must be designed to control and minimize airborne particles and microorganisms. TUMCells has a total of four cleanrooms – two of which meet the Bio Class II standard according to the German Biological Agents Ordinance (BioStoffV) and two of which are also registered as S2 laboratories according to the German Genetic Engineering Ordinance (Genetechnikverordnung). All rooms are equipped with modern, cleanroom-compatible safety cabinets, centrifuges, and incubators.
All starting materials, including human cells, must undergo rigorous quality controls to ensure safety and traceability. Contamination of the starting materials can compromise the safety and efficacy of the final product. Therefore, all starting materials are pre-qualified, and each incoming batch is electronically registered, inspected, and released by our quality control management.
Staff must possess the necessary qualifications and experience and be specifically trained in the aseptic manufacturing of cell-based products. Strict dress codes and hygiene measures apply to access to the production areas. Our operators have many years of experience and receive regular training and requalification. A rotating deployment system ensures that all employees perform the processes regularly and thus have mastered them.
All processes must be fully and comprehensively documented to ensure complete traceability. This documentation must cover the entire product lifecycle, from cell collection to administration to the patient. To guarantee data integrity at TUMCells, we strictly adhere to the ALCOA+ principles when handling our data.
All critical processes, equipment, and methods must be validated and qualified to demonstrate their reliability and suitability. We validate your quality control methods and are happy to support you in validating your manufacturing processes—including media fills to demonstrate that your processes can be carried out aseptically in a cleanroom. If your processes require special equipment, we can also help you define the requirements and verify its cleanroom compatibility. Thanks to our many years of expertise in validation and qualification, even the most challenging processes and equipment are no problem for us!
Quality control is a fundamental requirement for assessing the safety and efficacy of manufactured products. This includes verifying the cellular properties, sterility, purity, and efficacy of the final product. Cell-based testing systems are used to evaluate product safety and quality. Our experience with a wide variety of products and our adherence to regulatory requirements enable us to offer the best possible quality control strategy for your project.
