GMP Manufacturing

Close collaboration with our experienced process engineers aid our efforts achieve right first time scale-up of processes for GMP manufacture. The processes developed at our facilities are adapted to the plant environment in close collaboration with experienced process engineers. The limits of operating conditions are tested and their effect on yield and purity evaluated to gain full control over critical process parameters (CPPs). The choice of chemistry applied, as well as of solvents and materials, aims to guarantee process and patient safety. Special attention is paid to possible formation and detection of potentially genotoxic impurities (PGIs). Our scientists combine their knowledge and expertise to develop a process that delivers the requested API with the desired critical quality attributes (CQAs), yield, and solid form. Our efforts aim to achieve right first time scale-up. Analysts, chemists, and solid-state experts work together to achieve a comprehensive control strategy and ensure that the processes developed are readily and safely scalable in a manufacturing environment. Analytical support is provided throughout the project life cycle from development to manufacturing. Robust project-specific analytical methods are developed and validated appropriately throughout the clinical phase of the project.