A large pharmaceutical client presented two related API projects to STA after another CRO failed to meet the aggressive R&D timeline. The client requested completion of two 4-step API campaigns within 8 weeks with target deliverables of 7 and 8 kg of each API, respectively.
Our team optimized both processes by developing robust crystallization procedures and removing the need for column chromatography. We completed the on-time delivery of both APIs with high quality to the delight of our client. As a result of our excellent work, the client proceeded with the subsequent API campaigns at STA and we successfully produced 25 kg and 23 kg of each API, respectively.
We developed new synthetic routes for both molecules during the second API campaigns that avoided the use of expensive reagents and resulted in an 80% reduction in raw material costs. The optimized processes also led to ~90% increase in yield for both APIs.
Flexible state-of-the-art manufacturing assets consisting of 79 reactors ranging from 5 L to 5000 L, support projects from pre-clinical to pre-launch campaigns.
Our FDA approved kilo labs and pilot plants are well equipped and experienced to scale up all types of reactions producing grams to hundreds of kilograms of advanced intermediates and APIs.
All of STA's manufacturing sites operate 24/7, with on-site process chemistry, engineering, quality and analytical support.
Our successful "Fit-for-purpose" process development philosophy reflects our appreciation of your needs at every stage of clinical development delivering optimal value and shortest lead times.