High Potency API
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One Stop Platform for High Potency (HP) API from Preclinical to Commercial
WuXi STA has a one-stop HPAPI platform covering services from process R&D to commercial manufacturing in Changzhou and Jinshan, providing a robust dual supply chain from the two sites to our global customers. Our HPAPI facilities include R&D and kilogram-scale laboratories and manufacturing plants that handle HP compounds with an OEL of 10 ng/m3.
Our HPAPI capabilities include not only process development, non GMP and GMP manufacturing, but also prep-HPLC purification, wet and dry milling, such as jet, pin and hammer mills. And we provide options for API production both in batch and flow modes. WuXi STA provides integrated CMC services for high potency API and drug product (both oral and parenteral) from discovery to commercial manufacturing.
High Potency Laboratories
Our HP laboratories include R&D, kilogram-scale facilities in Changzhou and Jinshan sites, supporting all kinds of reactions with the reactor sizes up to 100 L. We have both non-GMP and GMP production lines, as well as special lines for hydrogenation reaction and flow chemistry to meet customers’ needs.
High Potency Plants
We have two HP production plants in Changzhou site, equipped with the reactor sizes up to 3,000 L, as well as prep-HPLCs and lyophilizers up to 10 m2 to support large scale HPAPI manufacturing.
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