- The Chengdu microbial manufacturing site will feature a 15,000L fermenter, capable of producing 80 to 110 drug substance (DS) batches annually, with the potential to expand to 60,000L.
- It will house China’s first dual-chamber lyophilization production line and a vial filling line, providing an overall drug product (DP) manufacturing capacity exceeding 10 million vials per year.
- The new site will incorporate WuXi Biologics’ recently introduced microbial expression platform EffiXTM for the development and manufacturing of biologics, ensuring high yield, consistent quality, and excellent stability and scalability.
CHENGDU, China, June 9, 2025 — WuXi Biologics (2269.HK), a leading global Contract Research, Development and Manufacturing Organization (CRDMO), announced today the commencement of construction for its new microbial manufacturing site in the Wenjiang district of Chengdu, a well-known and dynamic center for pharmaceutical innovation.
The new 95,000 square meter site will include a drug substance (DS) facility and a drug product (DP) facility dedicated to commercial manufacturing, supporting a diverse range of modalities, such as peptides, antibody fragments, plasmid DNA, enzymes, cytokines, and virus-like particles (VLPs). The site, expected to be ready for GMP production by the end of 2026, will be equipped with a 15,000L fermenter, enabling an annual production capacity of 80 to 110 DS batches. Future expansion could increase capacity to 60,000L. The facility will also feature China’s first dual-chamber lyophilization production line, along with a vial filling line, providing a DP manufacturing capacity exceeding 10 million vials annually, significantly enhancing WuXi Biologics’ commercial manufacturing capabilities for the global market.
These advanced facilities will utilize WuXi Biologics’ recently unveiled microbial expression platform EffiXTM for the development and manufacturing of biologics, ensuring high yield, consistent quality, and superior stability and scalability, and achieving titers above 15 g/L for non-mAb recombinant proteins. Equipped with advanced automated systems to ensure regulatory compliance, operational efficiency, and uncompromising quality, the facilities are also designed with a strong emphasis on energy conservation and sustainability. By optimizing process development approaches and using comprehensive carbon tracking, the company seeks to minimize its environmental impact while maintaining high production standards.
WuXi Biologics will leverage the Chengdu manufacturing site to produce VISEN Pharmaceuticals’ first commercial product, Lonapegsomatropin, a long-acting growth hormone used to treat pediatric growth hormone deficiency (PGHD). In addition to this key partnership, the company has also formed a strategic alliance with Virogen Biotechnology, a leading biotech firm. These collaborations, focused on commercial manufacturing operations, highlight WuXi Biologics’ growing portfolio of partnerships and its commitment to meeting the increasing demand for advanced biologic therapies.
Dr. Chris Chen, CEO of WuXi Biologics, stated, “We are pleased to begin construction of the Chengdu microbial manufacturing site, a significant addition to our comprehensive end-to-end microbial solutions. Given the expanding global market for microbial products and the unprecedented potential for next-generation therapies, our Chengdu site, with its substantial production scale and advanced technologies, is ideally positioned to take advantage of this trend. The strategic partnerships with leading pharmaceutical companies not only confirm the capabilities of our new site but also mark a crucial step in our ongoing commitment to accelerating the development and delivery of innovative therapies to patients worldwide.”
SOURCE WuXi Biologics
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