Flyer: API Development Services
Eurofins CDMO works closely with clients to provide phase-appropriate solutions to balance any immediate and long term API technology development needs.
After a clinical candidate is nominated, API properties such as polymorphs, salts and other physicochemical properties are evaluated during Early Phase Support. Phase II support then aids in establishing the potential commercial process. This involves a route or step rebuild, process optimization, stress studies and ICH stabilities, and many other services.
During Phase III/commercial support, a deep understanding of the process, impurities, and final API are important aspects for regulatory approval. Our team supports this through:
- Fate and purge studies
- Impurities marker synthesis and qualification
- Technology transfer to Client’s API CMO, as applicable