WuXi Biologics, a leading global Contract Research, Development and Manufacturing Organization (CRDMO), has kicked off construction of its new microbial manufacturing site for commercial production in the Wenjiang district of Chengdu, a renowned, vibrant hub for pharmaceutical development.
Spanning an area of 95,000 square meters, the new site is dedicated to a drug substance (DS) facility and a drug product (DP) facility for commercial manufacturing, encompassing a wide array of modalities, such as peptides,antibody fragments, plasmid DNA, enzymes, cytokines, and virus-like particles (VLPs).
Scheduled to complete GMP release for production by the end of 2026, the site will be equipped with a 15,000L fermenter, enabling an annual production capacity of 80 to 110 DS batches.
In the long run, capacity will be able to expand to 60,000L. Notably, the facility will house China's first dual-chamber lyophilisation production line alongside a vial filling line, with overall DP manufacturing capacity exceeding 10 million vials annually, a significant enhancement of WuXi Biologics' commercial manufacturing capabilities for the global market.
The state-of-the-art facilities will feature WuXi Biologics' recently launched microbial expression platform EffiX for the development and manufacturing of biologics with high yield, consistent quality, and superior stability and scalability, achieving titers that exceed 15 g/L for non-mAb recombinant proteins.
Equipped with advanced automated systems to help ensure regulatory compliance, operational efficiency, and uncompromising quality, the facilities have also been designed with a strong focus on energy conservation and sustainability. Through the optimisation of process development approaches and implementation of comprehensive carbon tracking mechanisms, the company aims to minimize its environmental footprint while maintaining high production standards.
WuXi Biologics will utilise the manufacturing site in Chengdu to produce VISEN Pharmaceuticals' inaugural commercial product, Lonapegsomatropin, a long-acting growth hormone for the treatment of pediatric growth hormone deficiency (PGHD). In addition to this landmark partnership, the company has also established strategic partnership with industry-leading biotech firm Virogen Biotechnology.
