Services

We manufacture advanced therapy medicinal products (ATMPs) for use in clinical trials. ATMPs are medicines based on cells or genes, made individually or in small batches for patients. We produce a range of cell-based therapies, including CAR-T cells and other modified immune cells (such tumor-infiltrating lymphocytes), tolerogenic dendritic cells, and gene-modified blood stem cells (CD34+ cells). All manufacturing takes place in our GMP-classified cleanrooms by trained staff, under strict quality control, so that each product meets the standards required for clinical use. We work closely with you to transfer your process into our facility and to produce your therapy reproducibly and safely.

We produce challenge agents for use in controlled human infection studies and other clinical research. Challenge agents are carefully prepared biological materials that are used, under strict medical supervision, to study how the body responds to a specific exposure and to test how well new treatments or vaccines work. Producing these agents requires the same rigorous quality standards as other medicines for clinical use. Manufacturing takes place under controlled conditions, with full quality control, so that researchers can rely on a consistent, well-characterized product for their studies.  

Bringing a therapy from the research laboratory to the clinic requires more than a good idea. A process that works at small scale in a research setting often needs to be redesigned to meet the requirements for manufacturing medicines for patients. We help you make this transition. Our team supports the development and optimization of your manufacturing process, the transfer of your process into our GMP facility (tech transfer), and the scale-up needed for clinical production. We work alongside you to make your process robust, reproducible, and compliant, so that it is ready for use in clinical trials.

The development and manufacturing of cell and gene therapies is tightly regulated. We help you navigate these requirements. Our team supports you in preparing the manufacturing and quality sections of regulatory submissions for clinical trials, including documentation for clinical trial applications submitted through the EU system. For the products we manufacture, a Qualified Person (QP) performs the final, independent assessment and certification (release) of each batch before it can be used in patients. This release is a legal requirement that confirms each batch has been made and tested in line with GMP and the approved specifications.  

Every batch we make must be shown to be safe, pure, and of the right quality before it can be used. Our quality control covers the testing needed to confirm this. Among other methods, we use molecular techniques such as quantitative PCR (qPCR), and digital PCR (dPCR) to characterize products and to test for identity, potency, and the absence of contaminants. These analyses support both the development of your process and the release of finished products, and provide the data needed to demonstrate that each batch meets its specifications.