WuXi STA, a subsidiary of WuXi AppTec, is a leading pharmaceutical development and manufacturing capability and technology platform company serving the life sciences industry with operations across Asia, North America and Europe. As a premier Contract Research, Development, and Manufacturing Organization (CRDMO), WuXi STA offers our worldwide partners efficient, flexible, and high-quality solutions for integrated CMC (Chemical, Manufacturing, and Controls) solutions from preclinical to commercial uses.
Shanghai Waigaoqiao Free TradeZone, China
DP R&D and manufacturing
Jinshan, Shanghai, China
(60 km south from Shanghai)
Wuxi City, Jiangsu
Wuxi City, Jiangsu, China
(117 km northwest from Shanghai)
Drug Product Manufacturing
Changzhou, jiangsu, China
(185 km northwest from Shanghai)
DS R&D and manufacturing
Oligonucleotide & peptide R&D and manufacturing
San Diego CA
San Diego CA ,USA
DS R&D and manufacturing
Our API research and development center is located in Shanghai's Waigaoqiao free trade zone. This facility comprises over 700 experienced process chemists and analytical scientists, 10,000 m² of process chemistry R&D labs, process analytical labs and process engineering labs. The R&D labs are equipped with international standard process research and analytical instruments. As part of the green chemistry initiatives, WuXi STA also established industry leading flow chemistry and bio-catalysis technology platforms. In both areas, the team has completed dozens of projects in both laboratory and plant scales.
Pharmaceutical development facility includes a 12,000+ sq. ft. formulation development facility as well as a 45,000 sq. ft. manufacturing facility for oral solid dosage productions supporting batch sizes ranging from 100 to 500,000 units. We’re also building a 109,000 sq. ft. commercial scale manufacturing facility for tablets and capsules in Shanghai which will be commissioned by the end of 2017.
WuXi STA's Jinshan manufacturing site covers 14 acres. As a cGMP manufacturing base, the Jinshan site can handle manufacturing projects ranging from kilo scale to metric tons scale. The Jinshan facility contains a kilo lab, 2 pilot plants and 1 commercial plant with reactors ranging from 5 L to 20,000 L. The facility also includes a high potency cGMP API facility, quality control labs, warehouses and a solvent tank farm.
WuXi STA Jinshan facility successfully passed three U.S. FDA PAI inspections in 2013, 2014, 2016 and 2018 and a Japanese PMDA PAI inspection in 2019. The facility has been approved by eight international regulatory agencies to supply commercial APIs for innovative drugs in the US, Europe, Japan, Canada, Switzerland, Australia, New Zealand and China.
We are well equipped and experienced to scale-up many types of reactions including asymmetric hydrogenations, air and water sensitive metal catalytic reactions, high temperature, high pressure, low temperature, and oxidations reactions. The site is enabled for high-tech manufacturing processing including large volume liquid nitrogen, continuous processing (flow chemistry), and biocatalysis.
WuXi city oral drug product manufacturing site currently occupies 59,000 m² including two cGMP commercial plants with 1 billion tablets/year and 100 million capsules/year capacity, respectively, as well as analytical labs, warehouse and utilities.
The Wuxi City site is staffed with a highly experienced production and QA&QC team. It is another step towards better enabling our partners through added capacity, greater flexibility, and our customer-centric approach to drug product manufacturing services.
The Wuxi STA Changzhou Site is a state-of-the-art integrated campus providing a unique one-site solution for customers to advance their active pharmaceutical ingredients (APIs) and advanced intermediates, including oligonucleotides and peptides, through preclinical and clinical development to global commercial launch. This facility successfully passed two U.S. FDA inspections in 2018.
This 39 acre/10,000 m² fully integrated R&D and cGMP manufacturing campus currently includes an R&D building, a pilot-scale manufacturing plant, two commercial manufacturing plants, QC building, hydrogenation plant, supporting units and warehouses.
Upon completion, the site will employ more than 500 scientists, with 10 pilot and manufacturing plants, adding more than 1,100 m³ of reactor volume.
In August 2016, WuXi STA opened a new site in San Diego US, which is one of the most innovative biopharma and biomedical hubs in the world. This site offers turnkey Process R&D, API and drug product manufacturing services for early phase clinical studies. This 4,242 m² facility is equipped with a cGMP pilot plant, cGMP kilo lab with 6 production bays as well as process chemistry and analytical labs.
The San Diego facility is staffed with a highly experienced scientific and production team. It is another step towards better enabling our partners through added capacity, greater flexibility, and our customer-centric approach to drug development and manufacturing services.