De Novo Route Design Driving Real Impact in Late-Stage Development
At SpiroChem, we leverage advanced molecular design and route-scouting technologies to help biotech and pharmaceutical teams overcome synthesis and scale-up bottlenecks. Complex spirocyclic building blocks shouldn’t stand in the way of a Phase III program—but for one U.S.-based biotech company developing an oncology candidate, that was exactly the challenge.
The team faced:
- A long, inefficient synthesis
- Low overall yield
- Costly steps that threatened project timelines and commercial viability
Our Approach:
SpiroChem partnered with the biotech team to rethink the chemistry from the ground up. In just six months, we delivered a fully redesigned synthetic route that:
- Reduced the sequence from 7 steps to 5 (2-pot)
- Increased overall yield from 10–15% to 70–80%
- Replaced seven chromatographies with just two precipitations
- Eliminated Pd-catalyzed and CO-based steps, using robust, scalable reagents
The Results
Production of a 500 g demonstration batch
Smooth tech transfer to >100 kg scale
Filing of a joint patent
Support toward the drug’s successful commercial launch
For biotech and pharma teams navigating late-stage or scale-up challenges, smart route design isn’t a “nice-to-have”—it can be the difference between delay and delivery.
Discover how SpiroChem can help accelerate your development programs.
