Contract Services
The Chemical GMP Synthesis Facility can assist in the synthesis of intermediates by providing fully integrated GLP and GMP manufacturing services, while avoiding the high costs typically associated with commercial suppliers.
 
Internal expertise in:
 
  • Asymmetric Synthesis
  • Transition-metal Catalyzed Reactions
  • Low-temperature Reactions
  • Heterocyclic Chemistry

Synthetic processes that are designed to:
 
  • Optimize Yields
  • Decrease Cycle Times
  • Improve Process Scalability

GLP/GMP synthetic capabilities:
 
  • Manufacture of API raw materials and intermediates from gram to multikilogram scales
  • Manufacture of fine chemical raw materials and intermediates from gram to multikilogram scales
  • Synthesis of various compound classes
  • Reference compound synthesis
  • Purification to Food and Drug Administration standards

API manufacturing
 
Our chemists specialize in complex organic synthesis and possess experience in both industrial and academic environments. With extensive experience and a solid scientific background, our team has a broad range of synthetic organic chemistry capabilities, along with the knowledge of the latest techniques and technologies in purification to deliver an optimized product.
 
Services include:
 
  • cGMP manufacturing for preclinical and clinical APIs (phase I/II)
  • Gram to multikilogram synthesis
  • Manufacturing of APIs using supplied protocols or through custom synthetic routes designed to suit your needs
  • Batch record generation
  • Technical support and technology information exchange
  • CMC/DMF support for regulatory submissions
  • Rapid scale up of existing routes with aggressive timelines
  • Asymmetric synthesis, transition metal catalyzed reactions, low temperature and high pressure reactions and heterocyclic chemistry