A large pharmaceutical client requested the production of 80 kg of a non-GMP advanced intermediate to support ongoing Phase 3 API production with a target completion within 1 month. The 6-step process involved complicated chemistries, column chromatography and was to be conducted using a risk-mitigating two batch per step production strategy.
Our process development team rapidly optimized the process by telescoping four steps, reducing catalyst loading and removed column purification by developing a robust crystallization. The process improvements led to the development of a robust and scalable process with a 38% increase in overall yield.
Our team completed the project, inclusive of process R&D, raw material ordering, manufacture and release, with-in the 1 month timeline and delivered 112 kg of product with an HPLC purity of 100%.
Flexible manufacturing assets consisting of 65 reactors ranging from 100 L to 5000 L, support projects from pre-clinical to pre-commercial launch campaigns.
Our FDA approved pilot plants are well equipped and experienced to scale up all types of reactions and support production of grams to hundreds of kilograms of advance intermediates and APIs.
All of STA's manufacturing sites operate 24/7, with on-site process chemistry, engineering, quality and analytical support.
Fully integrated, end-to-end process R&D and API manufacturing capabilities, ensuring seamless transfer of know-how and scale, as programs advance from preclinical to commercial.
Building on the foundations of the WuXi business, we understand from personal experience what you need and expect from a service provider.Contact us