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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

Related Links

Biopharmaceutical development services

We offer industry leading sterile pharmaceutical product development services. We provide complete CMC services from preformulation through clinical supply manufacturing; including scale up and technology transfer to our commercial manufacturing facilities. We have full development capability for small and biomolecules.

Preformulation

We can help you avert situations that can result from failure to detect polymorphic forms and poor salt selection. Complete physicochemical characterization of your API is a regulatory expectation. 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

Formulation development

Our development team brings the depth and breadth of scientific and regulatory experience to achieve your development objectives.

• Analytical methods development and validation
• Container/closure selection
• Lyophilization cycle development
• Aseptic process development
• Technology transfer and scale up support
• Statistical experimental design (DOE) approaches

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

Our integrated project management strategy optimizes the effectiveness of allocated resources.

• Strategic regulatory planning
• Singe 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)

Clinical manufacturing services:

• Aseptic processing and filling
• Vial and syringe filling capability
• Sterile liquid product
• Lyophilized product

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.