Wuxi city, China, May 20, 2021- STA Pharmaceutical, a WuXi AppTec company, today announces the opening of a new R&D center in Wuxi city site. With the new facility in operation, the Wuxi city site now becomes the second integrated drug product R&D and manufacturing campus for WuXi STA, in addition to its Shanghai Waigaoqiao site.
The new R&D center in Wuxi city site, with the area of 118,400 square feet to house more than 500 scientists, includes oral dosage platform, sterile injectable platform as well as analytical testing platform. The oral dosage platform is equipped with wet granulation and roller compaction systems, capsule and tablet formulation equipment, coating and in process control R&D equipment, etc., to provide R&D support to projects from preclinical to commercial. The sterile injectable platform provides a variety of filling formats such as vial, prefilled syringe and cartridge. It can also handle freeze-drying process.
Currently, the Wuxi city site has two oral solid commercial-scale plants, to provide manufacturing, packaging and labeling services. In the third and fourth quarters of this year, a new oral solid dosage GMP manufacturing plant and the first sterile injectable GMP manufacturing line will start operation. Furthermore, various novel technology platforms, such as continuous manufacturing lines for oral solid formulation will be available by early 2022.
At the opening ceremony, WuXi STA also launched two unique drug product service packages: F2CS: Fast to Clinical Supply and F4CM: Fast for China Market. F2CS is designed to shorten the time it takes to develop formulation and deliver clinical trial material for Phase I studies, and F4CM is designed to shorten the time it takes to complete technical transfer, late phase development, and process validation in China market.
As a premier Contract Development and Manufacturing Organization (CDMO), WuXi STA is fully established in the drug product field, offering fully integrated drug product solutions, 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. WuXi STA also built a comprehensive bioavailability enhancement technology platform including spray dried dispersion (SDD), hot melt extrusion, nano suspension and softgel & liquid filled hard capsules. In 2020 alone, WuXi STA's successfully delivered over 1200 drug product batches to partners around the world. In addition, WuXi STA successfully supported the launch of InnoCare's Orelabrutinib in China market, providing end-to-end support including drug substance, amorphous solid dispersion, tablet and packaging for this product.
Dr. Minzhang Chen, CEO of WuXi STA, commented: “we are glad to launch the Wuxi city formulation R&D center to further enhance our drug product platform. We will continue to expand our end-to-end CMC platform from drug substance to drug product, along with the global quality systems, to enable our partners worldwide to deliver more effective and accessible advanced therapies to patients globally.”
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 global operations. As a premier Contract Development and Manufacturing Organization (CDMO), WuXi STA offers our worldwide partners efficient, flexible and high-quality solutions for integrated CMC (Chemical, Manufacturing, and Control) solutions from preclinical to commercial uses. For more information, please visit: http://www.STApharma.com and follow us on LinkedIn.