Sterile Formulations

Leading the industry in aseptic pharmaceutical development

With over 80 years developing innovative technology for challenging compounds, our formulation team offers wide-ranging scientific and regulatory expertise to achieve your development objectives. We have full development capability for small and large biomolecules in dosage forms ranging from injectables and lyophilized drug products to ophthalmics. Our breadth of experience includes:

  • Analytical methods development and validation  (including HPLC, CE, SEC-MALLS, UV, physical, and bioassay methods)
  • Container/closure selection
  • Liposome, emulsion and solution formulation development
  • Lyophilization cycle development
  • Aseptic process development
  • Engineering batch production
  • Material compatibility studies
  • Technology transfer and scale up support
  • Statistical experimental design (DOE) approaches
  • Clinical and toxicology supply materials
  • Commercial materials
Catalent Benefits
  • Top-class facilities and equipment with strong track record of approvals
  • Over 1,000 scientists with targeted expertise
  • Customized services for your project according to specific needs
  • Integrated project management strategy for optimizing the effectiveness of allocated resources
  • Strategic regulatory planning with an excellent track record of success
  • Single point of contact project management assigned to every project
  • Facilitated contact with assigned scientific project leaders for all disciplines (formulation development, analytical development, clinical manufacturing)
Catalent Services
  • Toxicological manufacturing 
    • Small-scale processing and filling for toxicological use
    • Vial, dropper bottle, and syringe-filling capability
    • Liquid products (injectables, ophthalmics)
    • Lyophilized products
  • Clinical manufacturing 
    • Aseptic processing and filling
    • Vial and syringe-filling capability
    • Sterile liquid product
    • Lyophilized product
Catalent Capabilities

Our first-class facilities and expertise allow us to handle your most demanding product development challenges.

  • DEA categories: I–V
  • High potency compounds
  • Low oxygen headspace requirements
  • Difficult lyophilization cycle development
  • Light-sensitive compounds
  • Viscous products