Consulting
Medicinal products are subject to stringent requirements—the sooner you are aware of these and can incorporate them into the planning of your (pre-)clinical projects, the more likely they are to be successfully implemented.
We are happy to support you at every stage of your process with our expertise in cell therapeutics and good manufacturing practice, advising you on matters such as the selection of suitable materials, equipment, and processes.
Process development
Thanks to our experience and infrastructure, we offer an interface between research and development and enable you to transfer innovative cell therapies from preclinical development to clinical application in patients. Together, we bring your research results to a GMP-compliant environment and, after a successful technology transfer, can validate and qualify all aspects and components of the manufacturing process in accordance with regulatory requirements.
Manufacturing
TUMCells offers contract manufacturing of cell-based drugs by qualified permanent staff. Our unique concept also allows for the manufacture of cell-based drugs by external employees—always under the guidance, supervision, and professional responsibility of our Head of Manufacturing. This ensures that all processes are carried out in accordance with applicable regulatory requirements and the latest quality and safety standards.
Quality Control
We test your samples using validated methods to ensure compliance with predefined specifications - choose from a list of established methods or contact us to develop new methods.
As part of your project, we carry out routine testing during production at our facilities. In consultation with you, we develop the quality control strategy that is best suited to your project.
Facility capacity
Our facility in Munich has four modern clean rooms for working with Bio II substances, two of which are approved for genetic engineering work at safety level S2. The clean rooms suitable for the respective project can be rented exclusively for the duration of the project and flexibly equipped: with project-specific equipment from the TUMCells inventory or, depending on requirements, with equipment provided by your team. In this way, we ensure optimal utilization of our capacities and create ideal conditions for efficient, safe, and project-oriented manufacturing processes.
Training and education
We offer comprehensive training courses on the GMP-compliant manufacture of cell therapeutics, covering the important aspects of quality assurance and GMP-compliant documentation. This enables you and your team to become qualified to work in the cleanroom and manufacture the clinical product you have developed yourself. Our regular GMP clubs also present and discuss current topics from the world of GMP.
