#China #Chengdu #WuXi Biologics #Chengdu Facility #EffiX Platform

WuXi Biologics Unveils New Microbial Manufacturing Facility in Chengdu

WuXi Biologics, a prominent player in the contract research, development, and manufacturing arena, has officially commenced the construction of a new microbial manufacturing site in Chengdu, China. This facility, strategically located in the Wenjiang district, represents a leap forward in the company’s mission to meet the growing needs of the biopharmaceutical industry. Spanning a substantial 95,000 square meters, the site is being developed to support both drug substance (DS) and drug product (DP) manufacturing, with a capacity to handle a variety of modalities including peptides, antibody fragments, and virus-like particles.

Equipped with state-of-the-art facilities, the Chengdu site will incorporate a 15,000-liter fermenter, enabling the annual production of 80 to 110 DS batches. Moreover, there is potential for future expansion to 60,000 liters, indicating a commitment to scaling operations in line with market demands. Notably, the facility will house China's inaugural dual-chamber lyophilization production line, boosting the overall DP manufacturing capacity to beyond 10 million vials per year. This major enhancement of WuXi Biologics’ capabilities showcases their resolve to cater to the increasing global biotech requirements.

A remarkable feature of the new site will be the integration of WuXi Biologics' recently launched microbial expression platform, EffiX™. This platform is designed to facilitate the development and manufacturing of biologics, ensuring high yields, consistent quality, and enhanced stability and scalability. It is projected to achieve titers exceeding 15 g/L for non-mAbs, setting a new benchmark in the production of recombinant proteins.

To maintain high production standards while minimizing environmental impact, the facility has been designed with a focus on energy conservation and sustainability. WuXi Biologics plans to employ advanced automated systems to bolster regulatory compliance and operational efficiency, alongside implementing comprehensive carbon tracking mechanisms. These initiatives align with the global push for sustainability in biopharmaceutical manufacturing.

Importantly, WuXi Biologics has secured strategic partnerships that will utilize this new site, including a notable collaboration with VISEN Pharmaceuticals. The facility will be responsible for producing VISEN’s first commercial product, Lonapegsomatropin, aimed at treating pediatric growth hormone deficiency (PGHD). This partnership not only underscores WuXi Biologics' commitment to innovation but also highlights their role in advancing the development of critical therapies.

In addition to the VISEN collaboration, WuXi Biologics has established a partnership with Virogen Biotechnology, aiming to streamline commercial manufacturing operations. These alliances reflect WuXi Biologics’ broader strategy to expand its portfolio of partnerships and effectively address the heightened demand for sophisticated biologic therapies.

Dr. Chris Chen, the CEO of WuXi Biologics, expressed enthusiasm about the new site. He stated, “The construction of the Chengdu microbial manufacturing site signifies a powerful enhancement to our comprehensive microbial solutions. With the global market for microbial products on the rise, our Chengdu facility is set to leverage cutting-edge technologies to meet this demand.” He further emphasized the importance of the strategic partnerships, asserting that they validate the capabilities of the new site and mark a significant step in WuXi Biologics' dedication to accelerating the development and delivery of innovative therapies globally.

As the project moves forward, the new facility is anticipated to complete Good Manufacturing Practice (GMP) release for production by the end of 2026, positioning WuXi Biologics at the forefront of microbial production in China and beyond.

In conclusion, the establishment of the microbial manufacturing site in Chengdu represents both an ambitious expansion for WuXi Biologics and a critical investment in the future of biopharmaceutical production. With its innovative approach and advanced technologies, WuXi Biologics is poised to play a significant role in shaping the industry in the years to come.