With affordable therapy in mind, we think and design processes today that will enable our customers to reach their long-term objectives. As a Contract Development and Manufacturing Organization, we first translate bench processes in a robust and cGMP compliant process. In parallel, we work on optimizing the process to fast track its industrialization and to significantly reduce the risk related for the go-to-market.
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 characterization assays and optimize 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.
Always starting with our customers' feedback, we provide targeted solutions to optimize 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 optimization 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.
Our team draws on its significant expertise in process industrialization to develop processes that ensure consistent cell quality and yield, from small scale to clinical trials and, ultimately, to commercial production. We perform scalability evaluations of our customers' processes and develop models to help guide decision making towards flexible, cost efficient processes that can be manufactured at the scale required for all clinical or industrial stages. From scale-out to scale-up, we offer flexible strategies.