Sterile

Highest-quality aseptic development with complete physiochemical characterization

Dedicated to the highest standards, we provide complete CMC services from preformulation through clinical supply manufacturing, including scale-up and technology transfer to our commercial manufacturing facilities for sterile pharmaceutical product development. We have full development capability for small and large biomolecules.

Backed by our team of over 1,000 scientists, we can help you avert situations that result from failure to detect polymorphic forms and poor salt selection. Complete physiochemical characterization of your API is a regulatory expectation. We also provide studies necessary to elucidate the drug substance candidate with optimal physiochemical properties.

Catalent Benefits

• Depth of experience and breadth of scientific and regulatory experiences
• Ability to handle DEA categories I-V
• Extensive expertise with high-potency compounds as well as heat, light and oxygen sensitive compounds
• Integrated project management strategy across the entire development and supply of your product

Catalent Services

• 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