Small Molecules
Eurofins CDMO (Contract Development & Manufacturing Organization) provides active pharmaceutical ingredient (API) and drug product development services with pharmaceutical and biotechnology applications for complex, niche, small molecule programs from preclinical to Phase III and commercial manufacturing.
Our full range of drug development services covers preclinical development, formulation screening & development and analytical development. We offer non-cGMP and cGMP manufacturing as well as sterile and non-sterile manufacturing of clinical trial batches, niche molecules and complex small molecules (including HPAPI). We also work with clients and CMOs to provide process transfer and scale-up strategies, providing a seamless transition of programs from development through cGMP manufacturing.
We provide high-quality, customized solutions for complex products and unique production processes, specializing in the development of innovative formulation technologies and solutions to enhance bioavailability and control drug release for difficult-to-formulate drug candidates. Our API services are offered in facilities located in Canada and India and our DP services are offered in facilities located in Belgium, Canada, France and India.
Small Molecule API Development and Manufacturing
To support early phase programs, including IND-enabling projects, our Development Team can execute the following:
- Scouting of new, innovative and scalable synthetic routes
- Process development and process safety assessment
- Fit for Purposes optimization
- cGMP Starting Material assessment and establishment of regulatory concept
- Starting material and other raw materials sourcing and development
- Solid state R&D services
- Polymorph screening & salt selection
- Analytical method development and validation
- Impurity identification, isolation and Characterization
- cGMP manufacturing
- CMC support for IND filing
- Stability studies as per ICH
Small Molecule Drug Product Development and Manufacturing
- Pre-formulation, formulation development
- Preclinical supply
- Highly potent/cytotoxic
- Micronization/particle size reduction
- Services under non-GMP and GMP
- Drug product manufacturing (Non Sterile and Fill&Finish)
- Clinical Trial supply (Packaging & Logistics)
