Our client developed a small scale medicinal chemistry route to their lead molecule. To support IND-enabling studies and initial clinical supplies, STA was sought out to refine and optimize the existing discovery synthetic pathway to allow advancement into pilot plant production.
Our experienced process research team quickly evaluated the chemistry, developed an optimal synthetic route and initiated pilot plant production. Our team’s continuous assessment of the process led to further improvements in the GMP starting material processes and API recrystallization procedure that were realized in two subsequent API campaigns.
Our integrated services and flexibility provide innovative chemistry solutions to support timely and safe drug development for our customers. STA’s experienced project management teams understand what level of process development is required to ensure success of each of our client’s projects. Optimizing the medicinal chemistry procedure to support pilot plant production,allowed our client to rapidly initiate clinical studies. Concurrent with the clinical evaluation, Our team continues to work closely with the client to evaluate additional process optimization to ensure the program is positioned for long-term success.
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.