Small Molecule Analytical Chemistry



Overview

Comprehensive depth and breadth of analytical services to support rapid product development

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From discovery candidates to clinical trial materials to regulatory submissions to post-approval studies, we offer our partners an extensive array of small molecule analytical capabilities. 

Catalent's analytical offerings can be specifically tailored to our partner’s needs based on:

Catalent Services

We have extensive experience with a wide range of formulations as well as material categories including:

  • Rapid Microbial Methods (RMM) and Phase I sterile clinical supply manufacturing
  • Experience with the following formulations
    • Oral solid (immediate and sustained release), pulmonary, nasal, parenteral, softgel
  • Material categories
    • All hazard categories
    • DEA Category I-V
    • Photosensitive, moisture sensitive and oxidation sensitive compounds
    • Radioactive
Catalent Capabilities

Our focused studies and extensive analytical offerings provide a wide range of benefits than can help ensure your project success.  Our capabilities include:

  • Leading the industry in analytical expertise for both small and large molecule
  • Global Analytical Network - US & EU Centers
  • Tailored stability programs for small and large molecules across all dose forms
  • 20+ years operational excellence for all of your analytical challenges
  • Standard and customized services - placebos to controlled drugs
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
  • Kansas City, Missouri, USA
  • 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