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High Potency API
High potency API development
High potency API development cannot be separated from downstream analytical control and drug product manufacturing. WuXi STA’s HPAPI capabilities are part of an integrated CMC platform that links process development, manufacturing, analytical development, and oral and injectable drug product support within a consistent containment and quality framework.
WuXi STA’s comprehensive HP API platform covers services from process R&D to commercial manufacturing in two state-of-the-art facilities, providing a robust dual supply chain to support our global customers’ needs. Our HPAPI facilities include R&D and kilogram-scale laboratories and manufacturing plants that handle HP compounds with an OEL of 10 ng/m3.
HP API Technologies
- Prep-HPLC purification
- Wet and dry milling: jet, pin and hammer mills
- Hydrogenation
- Flow chemistry
Robust Capacity at Any Scale
High Potency Labs
- R&D, kilogram-scale facilities at our Changzhou and Jinshan sites
- Reactor sizes up to 100 L
- Traditional production lines with added flexibility of lines for hydrogenation and flow chemistry
High Potency Plants
- Two HP production plants at our Changzhou site
- Reactor sizes up to 3,000 L
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- Prep HPLCs and lyophilizers up to 10 m2 to support large-scale HPAPI manufacturing
Integrated Platform for High Potency Compounds
In addition to HP API development and manufacturing, WuXi STA provides high-potency drug product development and manufacturing for both oral solid and parenteral dosage forms. Delivered within the same integrated CMC framework, this approach reduces handling and transfer risk, maintains consistent containment and safety controls, and supports compliant scale-up from preclinical development through commercial manufacturing.
By the numbers
80 commercial API's
100%
4,000m3
Our technology
We leverage advanced reactors, multi-purpose plants, and specialized containment systems to manufacture small molecule APIs safely and efficiently – including high-potency compounds requiring stringent controls.
Our state-of-the-art technology enables complex multi-step syntheses, seamless scale-up, and consistent product quality. By combining purpose-driven pace with robust process automation and occupational hygiene practices, we deliver flexible, reliable manufacturing that keeps your supply chain moving forward with the highest standards of safety, quality, and compliance.
Our quality
Quality is at the core of every API we manufacture. Our dedicated quality systems, rigorous cGMP standards, and robust safety programs ensure consistent compliance from development to commercial supply – including for high-potency APIs requiring advanced containment.
We translate decades of operational knowledge into clear processes and meticulous oversight, so you can move forward with confidence. Speed means nothing without unwavering care, quality, and compliance – principles that guide every batch we produce.
Our locations
Our global network of state-of-the-art sites empowers us to advance small molecule development. With facilities across Asia, Europe, and North America, we mobilize expertise and capacity wherever and whenever you need it.
This global reach ensures seamless transitions and clear processes at every stage. We don’t just move fast; we move forward together – delivering quality, compliance, and innovation to help you achieve faster time-to-market for life-changing medicines.
Our history
From its foundation, our journey has been defined by a commitment to innovation, quality, and strong partnerships, driven by a purpose-driven pace.
We’ve evolved into a leading CRDMO with a perfectly orchestrated platform, consistently expanding our global footprint and capabilities to accelerate breakthroughs for our partners and patients worldwide.
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