Process Chemistry Research & Development

Essential Groundwork for any Compound

Client medicinal chemistry processes commonly face multiple risks and challenges, including:

  • Lengthy syntheses
  • Multiple chromatographies
  • Low yielding reactions
  • Synthetic steps that doesn’t work when scaling up from mg to hundreds of grams
  • Hazardous reagents
  • Infringing chemistries
  • Reaction conditions most API manufacturers can’t accommodate
  • Wasteful chiral chemistry

J-Star understands that when a synthesis contains too many of these challenges, the synthetic route can become prohibitively expensive - e.g., even a few hundreds grams could wind up costing 1+ million!

Let J-Star Research Help Your Program Succeed!

Fortunately, scientists at J-STAR have extensive experience in pharmaceutical process research and development spanning many decades of practical, hands on expertise. We can help you:

  • Lower the overall cost of goods to synthesize the API by reducing the number of synthetic steps required
  • Improve low yielding steps
  • Remove hazardous reaction conditions
  • Develop asymmetric syntheses
  • Reduce the number of chromatographies
  • Or re-design an entire route for a potential product or key intermediate

The Process Chemistry Experts

Our process research and analytical teams work closely together to integrate chemistry and analytical controls into the process at an early stage of the development cycle.

Our research is then documented into a JACS style development report outlining the chemistry and synthetic approaches attempted in the synthetic development effort, including detailed experimental with supporting analytical data.

Phase Appropriate Synthetic Chemistry Expertise

A few of the typical services offered as part of our process research efforts:

Route design

Scale up (up to 100 L vessels)

Evaluate existing syntheses and identify steps or sequences in the route that may pose a problem for large scale synthesis

Long term process design, route discovery and optimization

Institute appropriate analytical controls for in-process assays, end of reaction specifications and acceptable intermediate or API purity

Holistic integration with crystallization R&D, catalysis optimization and enabling technologies

NOR/PAR/DOE and fate & purge studies

Reference standard synthesis

Authentic impurity synthesis

Stable isotope label synthesis

Return on Investment and Benefits of Leveraging J-Star's Expertise

  1. J-Star Research reduced the number of steps in one client’s process from 11 steps to 3, bringing the cost of goods from >$500,000 down to <$7,500 per kg! In addition to these cost savings, our improved process also dramatically the shortened time cycles needed to prepare the API.
  2. J-Star Research has frequently been able to fix processes and deliver materials where other custom synthesis companies failed - giving new life to programs which had been in danger of going quiet!
  3. In some instances, J-Star Research has been able to help programs become acceptable licensing candidates, thus generating 8-figure licensing fees for our clients.