Process R&D/Drug Substance

Home DS & DP Capabilities Process R&D/Drug Substance

Essential Groundwork for any Compound

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

Lengthy syntheses
Multiple column chromatography steps
Low-yielding reactions
Scaling issues when moving from milligrams to hundreds of grams
Hazardous reagents
Non-environmentally friendly chemistries
Reaction conditions incompatible with most API manufacturers
Insufficient chiral chemistry applications

J-STAR understands that when a synthesis contains too many of these challenges, the cost of that compound can become extremely expensive—for example, even a few hundred grams could escalate costs to over 1 million USD!

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 or remove the number of column chromatography steps
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 in a JACS-style development report outlining the chemistry and synthetic approaches attempted in the process development effort, including detailed experiments with supporting analytical data.

Phase Appropriate Synthetic Chemistry Expertise

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

Typical Services

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

Benefits of Leveraging J-STAR’s Expertise

Shorten the Time Cycle

J-STAR Research reduced the steps in one client’s process from 11 to 3, lowering the cost of goods from over $500,000 to less than $7,500 per kg. Additionally, our streamlined process significantly shortened the time required to prepare the API.

Repair Process

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!

Licensing Candidates

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.

Cost Reduction

Process Optimization

We have a proven track record of fixing problematic processes and delivering materials where other custom synthesis companies have failed, revitalizing endangered programs.