Small Molecule Analytical Chemistry

Catalent Services     Catalent Capabilities      Facilities

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:

• Development phase
• Material type
• Standard versus specialized testing
• Integrated analytical/manufacturing, stand-alone analytical programs, or ad hoc analyses

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Catalent Services

• 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

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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

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FACILITIES

• RTP, North Carolina, U.S.A. – Center-of-Excellence for Analytical Services
  • General stats
  • Project director based work teams
  • Special material handling
  • Laboratory facilities
  • cGMP manufacturing
  • Operational excellence
• Kansas City, Missouri, USA
• Swindon, United Kingdom
  • 158,000sq
  • EMEA, FDA, ANVISA, Turnkey MOH & AEO Approved; CT-PAT approval for Catalent US
• San Diego, California