Wuxi STA, a Chinese R&D and manufacturing services provider for the pharmaceutical and healthcare industry, is expanding its regional footprint in Europe. The company’s Couvet facility in Switzerland is a manufacturing site for oral solid drug products at both clinical and commercial scales. The site has deep customization capabilities for packaging and labeling lines for both primary and secondary packaging. Wuxi STA also follows a dual-sourcing strategy to ensure the robustness of supply. The company’s integrated CRDMO platform can provide fast, flexible, and high-quality solutions to customers who need both API and drug products. In addition, Wuxi STA has invested in high potent manufacturing, and the company’s facilities support multiple parenteral dosage forms and different filling formats. Wuxi STA has significant expansion plans in place and leverages its global network to meet customer demand.
Wuxi STA, a Chinese R&D and manufacturing services provider for the pharmaceutical and healthcare industry, is expanding its operations in Europe. Currently, the company has facilities in the UK, Switzerland, and Germany, and is planning to increase its footprint in the region. In an interview with CHEManager, Jinling Chen, Head of Wuxi STA’s drug product business, and Jamie Andrews, Site Head of the Couvet manufacturing site, shared their insights on the strategy and goals of this European expansion.
The Couvet facility, which was purchased from Bristol-Myers Squibb in August 2021, is a drug product manufacturing site for oral solid dosage forms at both clinical and commercial scales. It is installed with top-class equipment, including automated visual inspection and fully integrated IT systems. The site has customizable packaging and labeling lines for both primary and secondary packaging. The facility has an annual capacity of one billion units of oral dosage forms and supplies eight key markets worldwide, including the US, EU, UK, Switzerland, Australia, New Zealand, Canada, and Japan.
The Couvet facility is a modern site, constructed between 2016 and 2018, and has already passed multiple inspections from various regulatory agencies, including the FDA, EMA, SwissMedic, and Japanese PMDA. It is also designed with industry-leading energy efficiency and environmental standards, receiving several industry awards for this. Chen and Andrews see the potential for the facility to become an increasingly important node in Wuxi STA’s global CRDMO network, which spans 14 sites across Asia, the US, and EU.
Wuxi STA’s European expansion strategy began with the Couvet facility in Switzerland, which was fully operational when purchased. The company’s growth prospects in Europe are expected to be significant, given its expansion plans and its presence in key markets across the region.
Wuxi STA, a Chinese R&D and manufacturing services provider for the pharmaceutical and healthcare industry, is expanding its Couvet facility to become a key drug product supply hub in Europe. The company is constructing new manufacturing, packaging, and labeling capabilities at the facility, which will double the capacity once fully operational. A larger warehouse implemented with an automated environment control system is also part of the near-future expansion plan to handle increasing logistics and supply demands.
To ensure robustness of supply, Wuxi STA has been pursuing a dual sourcing strategy for several years. European clients’ drug products can be manufactured at both the Couvet site in Switzerland and the Wuxi city site in China. This strategy provides an added layer of reassurance, as productivity can be maintained by one site if the other experiences any disruption. The Wuxi city site in China passed the EMA inspection last year and is currently supporting European clients. The company maintains the same high-quality standards across all its sites to ensure its clients receive a consistent, high-quality product from any site with a robust supply chain.
Wuxi STA has invested heavily in building and expanding its high potent (HP) manufacturing capabilities to better serve its global customers, driven by the growing demand for oncology drugs. The company opened its first HP (<1 µg/m3) oral dosage drug product manufacturing facility at the Wuxi city site last year and plans to open its first HP injectable drug product manufacturing line this year. With the well-established HPAPI development and manufacturing facilities in the Changzhou and Jinshan sites, Wuxi STA offers a one-stop solution for clients with HP drug outsourcing needs.
In addition to the capabilities at the Couvet and Wuxi city sites, European clients can expect similar high-quality drug product facilities across all of Wuxi STA’s sites. The company offers a range of services, including process research and development, analytical development and testing, clinical trial material manufacturing, and commercial drug substance and product manufacturing. Wuxi STA’s global network and dual sourcing strategy ensure that clients receive a consistent, high-quality product with a robust supply chain.
Wuxi STA, a Chinese R&D and manufacturing services provider for the pharmaceutical and healthcare industry, has recently invested in its injectable drug product platform. The company opened two wholly automated manufacturing lines in fully enclosed isolators, which support multiple parenteral dosage forms and different filling formats. In addition, Wuxi STA opened a new lipid nanoparticle (LNP) manufacturing facility to deliver more complex molecular modalities such as oligonucleotides. These investments provide new solutions and capabilities for European clients looking for high-quality and flexible drug product solutions.
Wuxi STA is well set for growth and has significant expansion plans in place. The Couvet facility is well prepared with its existing available capacity and the leverage of the global CRDMO network it connects to. Speed and quality are customers’ top priorities, and Wuxi STA leverages its strong capability in both API and drug product to provide fast, flexible, and high-quality solutions. The company’s integrated CRDMO platform ensures that clients receive a consistent, high-quality product with a robust supply chain.
European clients can expect similar capabilities and solutions from other Wuxi STA facilities, as the company maintains the same high-quality standards across all its sites. Wuxi STA offers a range of services, including process research and development, analytical development and testing, clinical trial material manufacturing, and commercial drug substance and product manufacturing. The company’s global network and dual sourcing strategy ensure that clients receive a consistent, high-quality product with a robust supply chain.
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