Process Chemistry R&D

Essential Groundwork for any Compound

The management team and staff at J-STAR have extensive experience in pharmaceutical process research and development that spans many decades of practical, hands on expertise. Clients seeking to improve troublesome steps in a process, reduce the cost of goods by removing expensive or poorly performing steps, or re-design an entire route for one of their potential products or key intermediates, will find value added input at the chemistry level from the team at J-STAR.

The process research team works closely with the analytical team to integrate the chemistry and analytical controls into the process at an early stage of the development cycle. The process research is then documented into a JACS style development report that outlines the chemistry and synthetic approaches that were tried as part of the synthetic development effort. This development report also includes a detailed experimental with supporting analytical data for the successful chemistry that results from our effort.

Capabilities

Shown below is a listing of the typical services that we offer as part of the process research effort:

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

Stable isotope label synthesis

Authentic impurity synthesis

Reference standard synthesis

NOR/PAR/DOE and fate & purge studies

Holistic integration with crystallization engineering and catalysis optimization

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

Near term phase appropriate route design and scale-up

Long term process optimization

ROI

We have, for example, reduced the number of steps in one process from 11 steps to three steps. This brought the cost of goods below the target of $7,500 per kg, from a starting point of over $500,000 per kg, not to mention the shortened time cycles to prepare the API. On many occasions, we have been able to fix a process and deliver material, where other custom synthesis companies were not able to. This resulted in those programs being re-vitalized. In some cases that has resulted in the program becoming an acceptable licensing candidate, resulting in multi-tens of million dollar licensing fees for our client.

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