WuXi Biologics, a contract research, development, and manufacturing organization (CRDMO), continues to enhance its global manufacturing network by increasing its global capacity to meet growing clients needs around the world. Weichang Zhou, Ph.D., President of Global Biologics Development and Operations & Chief Technology Officer, WuXi Biologics, outlined the company’s growth plan at the DCAT Member Company Announcement Forum held on March 20, 2023, at DCAT Week.  

WuXi Biologics achieved multiple important milestones in 2022 and continues its growth momentum in 2023. In November 2022, the company launched an integrated CRDMO center in Fengxian, Shanghai, China. The 1.6-million-square-foot Integrated Biologics CRDMO Center is built with global cGMP standards and can accommodate more than 3,000 employees. The grand opening included research, development, one drug-substance manufacturing facility, and two drug-product facilities for clinical manufacturing at various scales and volumes. Once fully operational, it will be able to provide services from early discovery to commercial manufacturing, all within the center. Additionally, in China, the company released a 48,000-L commercial-scale GMP drug-substance manufacturing facility in Hebei, China in October 2022.  

Looking ahead, WuXi Biologics plans to further enhance its global operations as it launches services to support the full biologics development and manufacturing supply chain in the US and Europe. Highlights are further outlined below.  

• The company’s Cranbury, New Jersey, site is WuXi Biologics’ first manufacturing facility to be operational in the US and has 150,000 square feet of space with full development and clinical drug-substance and drug-product cGMP manufacturing capabilities. Drug-substance Phase I expansion was GMP-released in August 2022 with an initial capacity of 4,000 L, which upon completing Phase II, will grow to 6,000 L, utilizing single-use technology. The drug-product facility will be ready for GMP formulation and fill-finish in 2024. 

• In September 2022, the company announced that its 189,500-square-foot site in Worcester, Massachusetts, which is currently under construction, topped-off the steel of this commercial biomanufacturing facility. 
• The company’s site in Dundalk, Ireland, was GMP-released in the fourth quarter of 2022, and received its first GMP Certificate from the Ireland Health Products Regulatory Authority. 

Overall, the company has a total estimated capacity of 580,000 L for drug-substance biopharmaceutical production planned by 2026 in the US, Ireland, Germany, Singapore and China, and over 10 drug-product facilities supporting various presentations (liquid and lyophilization fills, vials, and prefilled syringes).