Small Molecule Drug Substance: API Capabilities

If you're evaluating CDMOs for a complex small molecule or highly potent API program, Eurofins CDMO Alphora's capabilities are worth a close look. Based in Mississauga, Canada, with over 20 years in the business, this FDA and Health Canada-approved facility handles the full development arc from IND-enabling work through commercial manufacturing.

On the HPAPI side, they go up to Safebridge Class 4, meaning occupational exposure limits below 30 ng/m³. That's the high end of potency handling, and not every CDMO can claim it. R&D runs up to 5 L, their GMP kilo lab covers vessels from 20 to 60 L, and full GMP production scales to 125 kg per single batch with reactors up to 2000 L.

Beyond manufacturing muscle, the service envelope is genuinely broad: route scouting, process validation, solid state R&D including polymorph screening and crystallization engineering, CMC content authoring, nitrosamine assessment, and stability testing. For teams building out ADC programs, they also offer linker and warhead/payload development alongside mAb work.

Regulatory filing experience spans 25 countries, including the US, EU, Japan, and Brazil. That's useful if your commercialization path crosses multiple jurisdictions.

Contact Eurofins CDMO Alphora directly to discuss how their scale-up infrastructure and potency handling expertise fit your specific program timeline.