September 28, 2023
Contract development manufacturing organisation (CDMO) WuXi Vaccines has inaugurated a facility in Suzhou acquired from Harbour BioMed last year.
The 8,500 square-meter vaccine manufacturing site, located near Shanghai, will employ up to five hundred people.
The site’s drug substance production area includes two cell culture lines and one purification line capable of scaling up production from 50 to 1,000 L, with reserved capacity for up to 2,000 L.
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The drug product section, meanwhile, is equipped with an automatic vial washing, sterilizing, filling, and capping line.
“The opening will include two phases,” Jian Dong, CEO of WuXi Vaccines, told us. “Phase 1 includes drug substance and clinical/small to medium commercial drug product manufacturing. Phase 2 of the Suzhou site, which is expected to launch by the end of 2024, will include large-scale commercial DP manufacturing in liquid, lyophilized, with adjuvant in suspension and emulsion forms, mRNA LNP encapsulation and fill & finish in vials.”
WuXi Vaccines completed testing on a first isolator filling line earlier this year, providing the Suzhou site with support to fill and finish vaccines using 2R-50R vials. The site has an annual production capacity of 20 million vials and can accommodate the filling of vaccines in liquid or suspension formulation, as well as in a lyophilized (freeze-dried) state.
Opening the plant – acquired in 2022 from Harbour BioMed – represents a milestone for WuXi Vaccines: “We are very pleased with the opening at our first standalone vaccine CDMO site in China. This is a great achievement for our company as it allows us to significantly expand our services and capacities,” said CEO Jian Dong. “We look forward to working with our global partners to advance their pipelines, with the ultimate goal of improving the well-being of people worldwide.”
WuXi Vaccines’s plant in Dundalk, Ireland, is also heading toward completion. The site received GMP certification in 2022 is undergoing qualification and validation activities (CQV), with tech transfer set to commence soon.
With 160 employees, the facility will be used exclusively as part of a 20-year vaccine manufacturing contract with an undisclosed global pharma company valued at $3 billion. The plant, commissioned in 2019 at a cost of $240 million, kick-started the CDMO’s operations a year after the entity was created via a joint venture between WuXi Biologics and Shanghai Hile Bio-technology.
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