Building on deep technical knowledge about best cell therapy manufacturing methods and Good Manufacturing Practices, our teams are committed to providing the highest quality manufacturing, guaranteeing identity, purity, stability and potency for our customers' cells. To provide transparency and confidence to our customers, our project managers work as the interface between our clients and the operational team. In addition to significant expertise, our agile GMP infrastructures are designed to be adapted to our customers' specific needs, from technology transfer to the delivery of your cell therapy product.
When outsourcing your process development or manufacturing, successful technology transfer is key. It provides confidence that all aspects of the process and analytics are correctly handed over. This is why at MaSTherCell we have developed a reliable methodology in six steps that begins every customer collaboration. Starting with a transfer of all relevant documents, we design a project charter that defines the goals and timelines, as well as criteria for success and expected results. This is followed by several runs performed at our customers' facilities (observation runs) and within our infrastructures (development, engineering and qualification runs, and aseptic process simulations).
Once the process has been validated and all documents finalised and approved by both the customer and our QA team, clinical manufacturing is performed inside our validated GMP suites (class A, B and C). We work in full transparency with our customers who are regularly informed throughout the project on the timings, results and potential changes. Extranet network can be deployed for document management.
Working side by side with the QA, operation teams and first rate audited contractors, our logistics and technical service experts manage flows from the receipt of starting material to the release and on-time delivery of our customers' cell therapy products. Belgium is the best location for global distribution thanks to its central position and modern and efficient transport network. This allows us to deliver rapidly with full temperature control to our customers all over Europe.