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GMP Translation

We help turn cutting edge research into reproducible and reliable manufacturing strategies that comply with Good Manufacturing Processes (cGMP). We bring quality into your process. To ensure consistent product safety and quality from bench to clinics, we develop custom potency and characterisation assays and optimise processes in such a way they meet cGMP requirements, in all aspects. These aspects cover buildings, equipment and staff training, to raw materials, operational processes and quality control systems.

GMP translation includes the implementation of all documentation and operating procedures, the identification of the cell culture environment and the selection of the most efficient technologies. We also offer our expertise to develop information systems that will track documents and results to ensure a fast and safe release. 

Process Optimisation

Always starting with our customers' feedback, we provide targeted solutions to optimise their processes, taking into account long-term projections and investments. We select the most adapted technologies to the cell types and product characteristics that will achieve sustainable production capacities, while ensuring affordable and safe therapies. Our way to achieve process optimisation is the implementation of a lean manufacturing approach, combining process automation using the most efficient technologies, closed system with in-line control and digital batch record and cell-freezing systems.