Drug Substance / API
Combining process chemistry expertise with analytical solutions for your program
Eurofins CDMO (Contract Development & Manufacturing Organization) provides active pharmaceutical ingredient (API) and drug substance development services with pharmaceutical and biotechnology applications for complex, niche, small molecule programs from preclinical to Phase III and commercial manufacturing.
To support early phase programs, including IND-enabling projects, our Development Team can execute the following:
- Development of new, scalable API route options
- Route development and process safety assessment
- cGMP Starting Material assessment and establishment of regulatory concept
- Starting material and other raw materials sourcing and development
- Polymorph screening & salt selection
- Analytical method screening and preliminary stability profile
- Pre-formulation and preclinical supply
Our integrated group of companies provides a seamless transition for API and drug substances from the initial discovery stages of the program to commercialization and on-the-shelf. Expertise and support at each phase of the drug program is available from development, analytical services, cGMP manufacturing and later stage development and commercialization.