API Development
Eurofins CDMO's network of companies development team operates well-equipped laboratories to handle the most complex API development challenges.
Our expertise in the niche API’s allow us to develop and commercialize Highly Potent API’s. Research & Development suited and separated cGMP scale-up facility can handle potent compounds to less than 30 ng/m (Safebridge™ Class 4).
With a broad range of experience and knowledge of the latest technologies in organic synthesis, our chemists establish robust and economical routes for the synthesis of API’s. Furthermore, our substantial experience in process development allows us to successfully introduce chemical steps to cGMP scale up and thus advancing several API’s to commercialization.
To remain as efficient as possible throughout the API development stages, we employ Design of Experiment (DOE) and Quality by Design (QbD) approaches which enables it to validate a number of processes.
The Eurofins CDMO network of companies provides high-quality appropriate solutions which consider the client's immediate needs as well as the longer term commercial requirements. At every stage, we strive to provide the client with a development road map to provide the “Right Development at the Right Time”.
To support early phase programs where speed and quality are typically paramount, including IND-enabling projects, our Development Team can execute the following:
- Pre-clinical samples
- Development of reliable and scalable route including process economies assessment, regulatory strategies establishment and a reduction in Cost of Goods (COGS) study
- Synthetic & process chemistry and Analytical Method Development
- Analytical Method Qualification/Validation and Preliminary stability profile
- non-GMP and cGMP Scale-up
- IND document preparation & review (CMC or DMF preparation)
Regarding phase II & III programs, we apply incremental development which include the development and the optimization of processes, analytical development and enhanced control. We are able to provide impurity identification and control, API characterization and technology transfer for larger scale API’s as well as Regulatory Starting Material (RSM) Sourcing Development.
To support and guide process development for complex API processes, we have placed a significant emphasis on our analytical investments. Our analytical chemists are experienced in tackling the most challenging problems and establishing controls for the synthetic process and ensuring API quality.
