WuXi Biologics has begun construction of a new microbial manufacturing facility in Chengdu's Wenjiang district, set for GMP production by end of 2026. The 95,000-square-meter site will feature a 15,000L fermenter capable of producing 80-110 drug substance batches annually, with potential expansion to 60,000L. The facility will include China's first dual-chamber lyophilization production line and vial filling line, enabling production of over 10 million vials annually. The site will utilize WuXi's EffiX microbial expression platform, achieving titers exceeding 15 g/L for non-mAb proteins. The facility will produce Lonapegsomatropin for VISEN Pharmaceuticals and has established a partnership with Virogen Biotechnology, focusing on commercial manufacturing of various biologics including peptides, antibody fragments, and virus-like particles.
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Positive
New facility will have significant production capacity of 80-110 drug substance batches annually, expandable to 60,000L
Implementation of advanced EffiX platform achieving high titers exceeding 15 g/L for non-mAb proteins
Strategic partnerships secured with VISEN Pharmaceuticals and Virogen Biotechnology for commercial manufacturing
Facility will house China's first dual-chamber lyophilization production line with 10 million vials annual capacity
Negative
Significant wait time until operational readiness (end of 2026)
Large capital investment required for 95,000-square-meter facility construction and equipment
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The microbial manufacturing site in Chengdu will be equipped with a 15,000L fermenter, enabling the production of 80 to 110 drug substance (DS) batches annually with expansion potential to 60,000L.
It will house China's first dual-chamber lyophilization production line and a vial filling line, with an overall drug product (DP) manufacturing capacity exceeding 10 million vials annually.
The new site will feature WuXi Biologics' recently launched microbial expression platform EffiXTM for the development and manufacturing of biologics with high yield, consistent quality, and superior stability and scalability.
CHENGDU, China, June 9, 2025 /PRNewswire/ -- WuXi Biologics (2269.HK), a leading global Contract Research, Development and Manufacturing Organization (CRDMO), today announced that it 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 lyophilization 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 EffiXTM 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 optimization 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 utilize 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. These collaborations — centered around commercial manufacturing operations — underscore WuXi Biologics' expanding portfolio of partnerships and its drive to meet the growing demand for advanced biologic therapies.
Dr. Chris Chen, CEO of WuXi Biologics, commented, "We are excited to kick off the construction of Chengdu microbial manufacturing site, a powerful enhancement to add to our comprehensive end-to-end microbial solutions. With the booming global market for microbial products presenting unprecedented potential for next-generation therapies, our Chengdu site — with its robust production scale and cutting-edge technologies — is ideally positioned to capitalize on this trend. The strategic partnerships with leading pharmaceutical companies not only validate the capabilities of our new site but also represent a pivotal milestone in our unwavering commitment to accelerating the development and delivery of innovative therapies to patients worldwide."
FAQ
When will WuXi Biologics' new Chengdu manufacturing facility be operational?
The facility is scheduled to complete GMP release for production by the end of 2026.
What is the production capacity of WuXi Biologics' new Chengdu facility?
The facility will have a 15,000L fermenter capable of producing 80-110 drug substance batches annually, expandable to 60,000L, and can produce over 10 million vials annually.
What products will be manufactured at WuXi Biologics' Chengdu facility?
The facility will produce Lonapegsomatropin for VISEN Pharmaceuticals and various biologics including peptides, antibody fragments, plasmid DNA, enzymes, cytokines, and virus-like particles.
What unique features does WuXi Biologics' new Chengdu facility have?
The facility will house China's first dual-chamber lyophilization production line and utilize the EffiX microbial expression platform achieving titers exceeding 15 g/L for non-mAb proteins.
How large is WuXi Biologics' new manufacturing facility in Chengdu?
The facility spans an area of 95,000 square meters in the Wenjiang district of Chengdu.
