The NEDP process chemistry group works closely with medicinal chemists and chemical engineers to efficiently develop robust chemistry solutions for clients. This collaborative approach facilitates a smooth transition from bench to reactor, minimizing any risk of late-stage process issues that can negatively impact the time to clinic.

Our new state-of-the-art facility is well-equipped with chemical reactors ranging in size from 5 to 30 L (-65ºC to 200ºC), suitable for convenient preparation of most APIs on a kg scale. With a decade of experience in the pharmaceutical industry, we have the expertise to solve the most complex chemistry challenges and understand the importance of delivering results on time and within budget.

Services provided:

  • Route discovery, selection, and development
  • Process improvement and optimization
  • Analytical method development
  • Reaction feasibility determination
  • Rapid lot preparation for proof-of-concept studies
  • Preparation of discovery chemistry intermediates and analogs preparation (milligram to kilogram scale)
  • Custom synthesis
  • Process limits testing
  • Synthesis of analytical reference standards
  • Process impurity isolation, identification, and synthesis
  • Impurity profile development
  • Solid-state chemistry –salt selection, polymorph screening, amorphous dispersions, crystallization development
  • Freedom to operate assessment
  • Hazard evaluation

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