Home > Development > Biopharmaceutical development services

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 (NMR)
  • Isolation
  • Characterization
  • Reference standard synthesis / qualification
  • Proteins

• Stability
• Microbiology
• Chemical development

Clinical supply services

• Overview
• Comparator Supply Services

Regulatory consulting 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, call Catalent today. For more information, please fill out our contact us form or call a member of our sales staff at +1 866.720.3148.