Overview

Comprehensive analytical services to support rapid product development and enriched marketing

From rapid testing of early candidates to New Drug Application (NDA) submission, we help accelerate your efforts by providing immediate resourcing and technical expert support for your product. 
 

Catalent Services

Our range of analytical services is extensive:

• Rapid Microbial Methods (RMM) and Phase I sterile clinical supply manufacturing
• Characterization services 
  • Excipients 
    • Proof of structure
    • Establishment of purity as well as release
    • Specification development for excipient-masking transformations
  • Packaging components
    • Physico-chemical testing
    • Moisture permeability
    • Container-closure integrity evaluations
    • Extractables/leachables testing
  • Finished pharmaceutical products 
    • Method development activities to support deformulation studies, reverse engineering and determination of active/excipient ratios
    • Excipient identification and quantitation
  • Method development 
    • Solid oral - assay, impurities, dissolution, disintegration, moisture, hardness, friability, content uniformity, and cleaning methods
    • Liquid oral - assay, impurities, dose uniformity, osmolalility, viscosity, pH, and cleaning methods
    • Inhalation - dose content uniformity, shot weight, particle size, spray pattern, plume geometry, assay, impurities, moisture, leak rate, leachables, and microbial methods
    • Topical - assays, impurities, pH, viscosity, dissolution, moisture, and microbial methods
    • Sterile liquids and solids - assay, impurities, pH, leachables, microbial, and sterility as well as process validation support for water systems
• Process validation
• Microbiological testing 
• Mass spectrometry 
• Chemical development 
• Drug substance testing 
  • Elucidation of structure
  • Assignment of purity
  • Polymorphism evaluations
  • Phase solubility studies
• Impurity profiling (including stereoisomers) 
  • Preparatory scale-up separations
  • Isolations
  • Purifications
  • Structure elucidation
  • Purity assignment
• Biopharmaceuticals

Catalent Capabilities

We offer a wide range of pharmaceutical testing services:

• Metals analysis
  • Inductively Coupled Plasma Mass Spectrometry (ICP-MS)
  • Inductively Coupled Plasma Atomic Emission Spectrometry (ICP-AES)
  • Graphite Furnace Atomic Absorption Spectrometry (GFAAS)
  • Cold Vapor Atomic Absorption Spectrometry (CVAAS)
  • Flame Atomic Absorption Spectrometry (FAAS)
• Chromatography 
  • HPLC
  • GC
  • Chiral HPLC
  • TLC
  • CE
  • Semi-Prep LC 
• Compendial testing
  • UV-VIS spectrophotometry
• Thermal analysis
  • Differential Scanning Calorimetry (DSC)
  • Thermogravimetric Analysis (TGA)
  • Dynamic Vapor Desorption (DVS)
• Mass spectrometry (GC/MS and LC/MS)
  • Dissolution/disintegration
  • Physical testing 
• Organic spectroscopy
  • Nuclear Magnetic Resonance Spectroscopy (NMR)
  • Fourier Transform Infrared Spectrophotometry (FTIR) 
  • Polarimetry
• Particle analysis
  • Malvern
  • Microscopy
  • Sieving
  • HIAC
  • Cascade impaction 

Facilities

• RTP, North Carolina, U.S.A. - Center for Development and Analytical 
  • General stats
    • Over 330+ personnel in 200,000 sq. ft. of laboratory space
    • 9,500 sq. ft. of GMP Manufacturing for CTMs
  • Project director based work teams
    • Effective resource design including:
      • Project management
      • Project directors
      • QA
      • Scientific staff supported with administrative assistants
  • Special material handling
    • DEA-controlled substances
    • Cytoxics
    • High potency
    • Light- moisture- and oxygen- sensitive compounds
    • Cephalosporin/penicillin
    • BSL 2/3
    • Hormonals
    • Radioactive licenses
  • Laboratory facilities
    • 6 buildings in Southport Business Park
    • 200,000 sq. ft. laboratory space
    • 22,750 cu. ft. ICH stability
  • cGMP manufacturing
    • 9,500 sq. ft. 
    • Respiratory
    • Sterile (liquid/lyo)
    • Phase I/II scale
  • Operational excellence
    • Visual management of workload 
    • Metrics driven
    • Value-stream approach
• Swindon, United Kingdom
  • 158,000sq
  • EMEA, FDA, ANVISA, Turnkey MOH & AEO Approved; CT-PAT approval for Catalent US
    • Featured Technologies:
      • Zydis® fast-dissolve technology
      • Development and clinical technologies
      • Regulatory consulting services
    • Analytical Testing Services:
      • Raw material and finished product release testing
      • QP Release
      • Method Development and Validation
      • Compendial testing
      • Stability testing and storage