Starting material sourcing, pricing, lead-time, and quality issues can have a significant impact on project timelines, downstream processes and finished product quality.
We have developed robust and reliable alternative internal processing and external sourcing solutions for our customers starting materials to support clinical and commercial batch production. To provide assurance in supply, reduce cost and shorten lead-time, STA has the capacity to back-integrate both non-GMP and GMP starting material processes. To overcome starting material impurity issues, STA proactively identifies and synthesizes impurities to support analytical method development and fate tracking.
STA's offers secure manufacturing and supply solutions for our customers starting materials, advanced intermediates and API needs from preclinical to large-scale commercial manufacturing.
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.