CLOSE
Reliable evaluations to ensure your long-term success
With development capability for both small and large biomolecules, we provide complete CMC services for oral, inhalation, and sterile products from preformulation through clinical supply, including scale-up and technology transfer to our commercial manufacturing facilities. Our rigorous physiocochemical characterization of APIs - a regulatory expectation - can help you avert situations that result from failure to detect polymorphic forms and poor salt selection. Supported by integrated project management, our balanced preformulation approach can ensure a consistent quality of product from discovery to clinic, and beyond.
Learn more about how we can help your preformulation goals in these areas:
Catalent Benefits
- Scientific, regulatory, and product development expertise
- Proprietary technologies to enhance product performance and extend your product's lifecycle
- Critical mass of facilities and personnel to customize your project according to specific requirements
- State-of-the-art equipment
- Personalized project management from development to market
Catalent Services
We provide studies necessary to elucidate the drug substance candidate with optimal physicochemical properties.
- Salt synthesis and salt form selection
- Polymorph screening
- Solid and solution state stability
- pH/temperature degradation rate profile
- pKa determination
- pH/solubility profile
- Adsorption/desorption
- Excipient compatibility studies
- Container/closure compatibility
