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Enabling technology
Our API development and manufacturing services are bolstered by a robust portfolio of enabling technologies that support small to large-scale production.
Crystallization and Particle Engineering
WuXi STA has significant experience in crystallization process development and milling and micronization – resulting in the delivery of the highest-quality drug substance.
We provide micronization support from lab to production scale – and support high potency compounds with an Occupational Exposure Limit (OEL) of 3-5 ng/m³.
Our expertise includes polymorph, purity, residual solvents, particle size distribution, morphology, filtration, and drying investigation.
Biocatalysis
Our comprehensive biocatalysis platform offers a complete solution for all biocatalysis challenges:
- Enzyme screening
- Enzyme evolution
- Enzyme fermentation
- Process development and production
Flow Chemistry
From our decades of experience, WuXi STA has established an industry-leading flow chemistry platform supporting drug substance R&D and manufacturing from pre-clinical to commercial.
Whether the project is GMP or non-GMP production, our clients can expect an efficient, scalable and repeatable process that yields results.
- 32 flow lines
- 50+ types of reactions
Prep HPLC
WuXi STA offers a variety of preparative chromatographic services to accelerate the purification process of your APIs, high potency APIs, chiral compounds and intermediates, including:
- High Performance Liquid Chromatography (HPLC)
- Supercritical Fluid Chromatography (SFC)
- Simulated Moving Bed (SMB)
We have extensive experience in handling preparative chromatographic method scale-up, method optimization, process validation, pilot and commercial manufacturing.
Our cutting-edge facilities provide a wide range of purification capacity from gram scale to metric ton scale to support your projects at any stage.
By the numbers
28 types of reactions
3200+ in-house enzymes
110 steps manufactured
90+ MT products
22,500L total fermenter volume
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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