API Commercialization Support
Combining process chemistry expertise with analytical solutions for your program, Eurofins CDMO (Contract Development & Manufacturing Organization) provides active pharmaceutical ingredient (API) development services and commercialization support through the all process.
All our commercialization support services can be provided as part of an existing program or stand-alone / one-off. As programs head towards commercialization, the process is mapped with direction provided by CMC Gap Analysis, Risk Assessment and Design- of-Experiment methodology, leading to an understanding of the operational space and potential critical process parameters. The impurity profile is further examined, with targeted fate & purge studies, designed to ensure clearance of impurities and knowledge of carry-over and tolerable levels. Once the process has undergone successful validation, our CMC experts can support with registration with global Regulatory Authorities and continue to follow your project during and after the market launch. The final objective is to achieve commercial approval with the client’s chosen API CMO.
Eurofins CDMO is also able to support the commercialization of your API molecules thanks to our cGMP flexible facilities and the breadth experience of our team. We operate multiple USFDA and Health Canada approved facilities with process volumes upwards of 500L. These facilities have undergone multiple PAI inspections and are routinely used for several applications. We proceed at the demonstration of the optimized process to confirm yields, control of impurities, and control of critical parameters. We also utilize our facilities to prepare and execute process validation batches or for commercial re-supply.
To support your API molecules commercialization, our facilities have capabilities including:
- Scale-up reactor vessels of 20L, 50L, 60L, 200L and 500L
- Cryogenic and Hydrogenation conditions
- Chromatography, including Biotage from bench to large scale
- Isolator containment for compounds with OEL’s <30 ng/m³
Beyond state-of-the-art facilities, we have a breadth of experience with a variety of chemical transformations including reductive amination, organometallics (RMgX, BuLi, LDA), halogenations (POCl3, SOCl2, SO2Cl2), reductions (LiALH4, NaBH4, DIBAL), suzuki couplings, Pauson-Khand cyclization, peptide chemistry or catalytic, hydrogen transfer.