High Potency API
High Potency API
One stop platform for high potency (HP) API from preclinical to commercial
WuXi STA has an industry-leading one-stop HPAPI platform covering from process R&D to commercial manufacturing in Changzhou and Jinshan sites, China, providing a robust dual supply chain to our global customers. Our HPAPI platform includes a number of HP R&D labs, HP kilo labs, and 2 HP production plants that handle HP compounds with an OEL limit of 10 ng/m3.
Our HPAPI capability also includes HP milling for both wet & dry milling, including jet mill, pin mill and hammer mill. We also provide options for API production both in batch mode and flow mode.
High Potency Labs
Our HP labs include both R&D labs and Kilo GMP labs in Changzhou site and Jinshan site, supporting all common reactions with the reactor size up to 100L. We have both non-GMP and GMP production lines, as well as special lines for hydrogenation reaction and flow chemistry to meet different customer needs.
High Potency Plants
We have 2 HP production plants in Changzhou site, equipped with reactors size up to 3,000L, as well as large scale prep-HPLC and lyophilizers up to 10m2 to support large scale HPAPI manufacturing.
