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Development

Biopharmaceutical
development services

• Overview

• Gene expression

  • Overview
  • GPEx® expression technology
  • Monoclonal antibody (mAb) production

• Biomanufacturing
• Biopharm product development
• Biosafety testing
• Bioassay development
• Bioanalytical PK/ immunogenicity
• Clinical manufacturing

Product development
services

• Overview

• Oral

  • Overview
  • Preformulation
  • Formulation development
  • Proprietary technologies
  • Clinical manufacturing

• Pulmonary and nasal

  • Overview
  • Preformulation
  • Formulation and product testing
  • Clinical manufacturing

• Sterile

• Analytical

  • Overview
  • Stability testing and storage
  • Metal analysis
    (AKA trace analysis)
  • Compendial testing
  • Mass spectrometry
    (GC/MS and LC/MS)

• Structural chemistry

  • Overview
  • Fourier transform infrared spectroscopy
  • Extractables routine control methods
  • Forced (Stressed) API and drug product degradation
  • Mass spectrometry (LC-MS, LC-MS, GC-MS)
  • Nuclear magnetic resonance (LC-NMR)
  • Isolation
  • Characterization
  • Reference standard synthesis / qualification
  • Proteins

• Stability
• Microbiology
• Chemical development

Clinical supply services

Our aseptic liquid formulation and filling facility is cGMP validated. We utilize segregated Class 100 aseptic filling suites, controlled manufacturing and processing areas, and on-site QC Chemistry and Microbiology labs.

Key Capabilities Include:

• Vials
• Prefilled syringes
• Lyophilization
• Blow/Fill/Seal
• Recombinant protein manufacturing

Key benefits:

• Proven record of success in tech transfer and scale-up
• FDA & EMEA approved facility
• Seamless alignment with our upstream formulation, analytical and process development capabilities
• Highly flexible suite of capabilities
• Automated, semi-automated and hand filling
• Significant lyophilization capacity

For capabilities that meet your needs, and outcomes that exceed your expectations, partner with Catalent today. For more information fill out our Contact us form or call a member of our sales staff toll-free at 866.720.3148.