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

• Stability
• Microbiology
• Chemical development

Clinical supply services

We offer a complete line of services that includes GLP-analytical microbiology services and specialty services. We have an experienced team of pharmaceutical microbiologists who can provide you with method development support, consulting and problem-solving skills, and analytical flexibility. You can choose testing via our Routine Analytical Testing Methods or request a program designed specifically to your sampling and testing requirements.

We are committed to providing quality testing services, rapid data turnaround, and effective communication to ensure your projects success.

Specialty services

• Barrier isolation testing
• Sterility testing for release
• Vaporized hydrogen peroxide sterilant
• Ribotyping testing
• DNA-based microbial identification
• Bacterial ID
• Genotypic method

Compendial Testing

• USP, EP, JP, BP
• Microbial limit tests
• Plate count validation
• Preparatory testing
• Microbial identification
• Bacterial endotoxin tests (LAL)
• Inhibition/enhancement screening
• Gel clot
• Kinetic chromogenic
• Sterility tests
• Bacteriostasis/fungistasis screening
• Membrane filtration methods
• Direct transfer techniques
• Antimicrobial effectiveness testing
• Method validation
• Preservative challenge
• Antibiotic assays and method validation
• Purified water testing
• Total organic carbon

Environmental monitoring

• Consulting and training
• On-site sample collection
• Microbial identification

Container closure integrity evaluation

• Dye intrusion
• Microbial ingression
• Customized methods

Cleaning / disinfection validation

• Consulting and training
• Method development / validation

USP water testing and system validation

• High-throughput experience
• Conductivity, pH, TOC
• Microbial counts
• Pathogen screens
• Particulate analysis
• Endotoxin testing

Preservative systems formulation support

• Minimum inhibitory concentration
• Minimum bactericidal concentration

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.