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:
- 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
Return on Investment and Benefits of Leveraging J-STAR’s Expertise
- J-STAR Research reduced the number of steps in one client’s process from 11 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 shortened time cycles needed to prepare the API.
- 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!
- 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: 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.
- 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.