Drug Development
- Improved Access to the Core Scaffolds
- Optimize Problem Points
J-STAR’s team of 50 PhD process chemists have an impressive track record of designing cost effective and efficient synthetic routes to target molecules in support of the biopharmaceutical industry. We can partner with you to design and execute a research operating plan so that the scope of synthetic route design is integrated into your program’s need and works with its lifecycle stage and budget.
Drug Development
Candidate Confirm
First-in-human (FIH) Enabling Toxicology Aupplies
CGMP Clinical Supplies
IND Filing Date
Large-Scale Manufacturing
Most early-stage engagement occurs prior to candidate selection. This synthetic work may be centered on an improved mode of access to a target common scaffold used for multiple preclinical candidates.
As such, a high ROI (Return on Investment) is realized in that improved access to the core scaffold is axiomatically beneficial to the program regardless of the structure of the candidate chosen to advance.
Another common area for early engagement is the proactive retooling of a known or suspected trouble spot in the synthetic route that may cause downstream delays in chemical scale-up. A small proactive investment in the early-stage of a program can frequently help accelerate down-stream activities.
After candidate selection, all programs seem to share a common theme
– speed, speed and more speed!
A typical biopharmaceutical new chemical entity (NCE) program emphasizes rapid advancement to each of the following three milestones:
First-in-human (FIH) Enabling Toxicology Aupplies
CGMP Clinical Supplies
IND Filing
Date
Numerous strategic elements come into play in this space, but phase-appropriate development is often a central theme.
Our wealth of experience, ability to adapt to a continual influx of new data and pragmatic approach to meeting your program’s timeline and budgetary constraints is paramount to our partnership model.
As speed is a central tenet in early- and mid-stage programs, a fit-for-purpose (FFP) synthetic route supportive of that goal is often used. While this accomplishes requisite project goals in the early life cycle phase of a drug candidate, the FFP route is not always the best match for the larger scale production needed for chronic toxicology studies, later clinical studies or commercial production.
In concert with strategic trigger points in your program’s timeline, process objectives and the state of the incumbent chemistry, our experienced team of process chemists are ready to design a more efficient route to a chemical intermediate or final API target, thus improving overall efficiency, time cycle production and cost-of-goods (COGs).
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