Shanghai Waigaoqiao Drug Substance R&D team has several thousands of experienced process chemists and analytical scientists, 2.5 acres of process chemistry R&D labs, process analytical labs, and process engineering labs.
Shanghai Waigaoqiao site has integrated Drug Product platform, from preformulation to commercial manufacturing, including solid-state development, developability and formulation research, formulation development, and Clinical Trial Material (CTM), and commercial manufacturing in various oral and injectable dosage forms.
The 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 and 2019
This 74 acre fully integrated R&D and cGMP manufacturing campus currently includes 2 R&D center, 11 plants, and 950+ scientists, 400+ reactors. By the end of 2022, it will expand to 2 R&D center, 15 plants, 1,927 m3 total reactor volume.
The Jinshan site is an integrated Drug Substance process R&D and commercial manufacturing campus, including a new 3.7 acre R&D center with capacity to host 800+ scientists, and 5 manufacturing plants with reactors ranging from 5 L to 20,000 L. The facility also includes high potency R&D labs & plants and one enzyme fermentation plant.
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 scale chromatography, continuous processing (flow chemistry), and biocatalysis.
The Wuxi city site is an integrated drug product R&D and manufacturing campus, including one R&D center and two oral solid commercial-scale plants. The R&D center with an area of 2.8 acres to house more than 500 scientists, includes oral dosage platform, sterile injectable platform as well as analytical testing platform. The two oral solid commercial-scale plants provide manufacturing, packaging, and labeling services. The newly opened R&D center includes oral, injectable and analytical platforms.
The parenteral formulation platform at our Wuxi city site is designed for vials, cartridges and pre-filled syringes with state-of-the-art equipment. And it supports the Lipid Nanoparticle(LNP) formulation development and manufacturing.
In August 2016, WuXi STA opened a 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 1 acre 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.
In August 2021, WuXi STA completed the acquisition of Bristol Myers Squibb’s manufacturing facility in Couvet, Switzerland. It is newly constructed in 2016-2018, designed with industry-leading energy efficiency and environmental standards and has been inspected by US FDA, Japan PMDA, and SwissMedic in 2018-2020.
The Couvet site is equipped with a manufacturing plant, a GMP warehouse as well as quality control labs. This site offers commercial drug product manufacturing and packaging for capsules and tablet dosage forms and supports bottle & blister packaging.
With a total area of 170 acres, the Taixing site is designed to support global partners with integrated API process R&D and manufacturing from preclinical to commercial stages. The first phase of the project, with an area of about 53 acres, is expected to be fully operational in 2025, adding ~1,000m3 TRV.
The first phase of the project also includes industry-leading new molecular modality platforms from laboratory to commercial scale, such as high potency APIs, oligonucleotides and peptides.
In June 2021, WuXi STA announced that it will build a new pharmaceutical manufacturing campus in Middletown, Delaware US. The 190-acre new facility in Middletown will feature space for testing laboratories formulation R&D and manufacture and packaging of oral solid pharmaceutical products and sterile products, which is expected to start operation in 2025.
WuXi AppTec, a leading global provider of R&D and manufacturing services that enable the global pharmaceutical and healthcare industry, announced a plan to build a new 50-acre R&D and manufacturing site in Singapore on July 19, 2022, totally 7 plants in plan. The company intends to invest up to S$2 billion (approximately US$1.43 billion) to construct and operationalize the site, which aims to further enable global partners to advance healthcare innovations. The investment is expected to be made in stages over the next 10 years, depending on the company's business needs.
In Phase I project, we plan to build 2 plants for small molecule API with 350+ m3 TRV and 1 plant for oligonucleotides, peptides and complex chemical conjugates. It's expected to start operation in 2026.