Chemical development

Development Strategy Consulting

• Technical review of API chemistry package
• RFQ preparation
• Contract synthesis provider evaluation and management
• Tech transfer assistance
• cGMP audits and contractor technical evaluatio

Chemical Processs Research and Development

• Expertise in multi-step synthesis of diverse structural types, including small molecules, aromatics, heterocycles, peptides, unnatural amino acids, PEGs, steroids, sugars, nucleosides and macrocycles
• Synthesis and full characterization of primary and working reference standards
• Synthesis and structural characterization of metabolites, reaction by-products, and related substances
• Preparation of starting materials and intermediates
• Synthesis of compounds labeled with stable isotopes, fluorescent tags or related markers and tracers
• Process research
  • New route discovery
  • Technical comparison of multiple routes
  • Reaction screening
  • Small scale proof of concept
• Process development
  • Optimize process yield, efficiency and safety
  • Technology transfer program
• Synthesis at scale to support preclinical development

cGMP Synthesis and Scale-up

• cGMP synthesis at the kilogram scale for clinical trials through Phase 1
• cGMP scale-up support for strategic intermediates
• FDA-compliant cGMP suites, with HEPA filtration and temperature/humidity control
• All validated processes and analytical methods performed under strict cGMP guidelines to ensure compliance for your in-process testing, release testing and stability of API
• Technical reports, regulatory documentation and technical transfer packages to support CMC filing

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.