Route Development — API

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Route Development — API

The Challenge

Develop a Feasible Chemical Synthesis Route to Enable GLP and GMP Production of API

The Barriers

  • Sponsor had no prior chemical knowledge on the compound or synthesis
  • Only a Med Chem route was provided
  • Tight timelines
  • Pd levels were initially ~10,000 ppm in Med Chem route and reduced via chromatography

Process Chemistry Services

  • Develop and demonstrate a robust chemical process to enable GMP production of the API for use in FIH clinical trial
  • Understand and control impurity formation in chemical steps while maintaining high yields

Scientific Data / Explanation

  • Developed API step chemistry with control over all process and SM impurities, while allowing for a high yield (87%)
  • Went even further to develop a crystallization for the final API salt
  • Developed a unique approach for Pd removal in step 2 of 3 and eliminated chromatography
  • Final API had 10-20 ppm Pd without the use of expensive scavengers
  • Developed robust, process-friendly procedures and demonstrated with 100 g API
  • Route and process were suitable for future GMP use

Purity Profile: Med Chem Route

Purity Profile: Final Avista Procedures

The Outcome

  • Successfully created high-purity intermediates and crystallization of the API
  • Delivered a suitable route for GLP and GMP production
  • Delivered on time

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