The DP facility is equipped with an automatic vial washing, sterilizing, filling and capping line, which can support the clinical production of both liquid and lyophilized products
WuXi Vaccines has launched its first standalone vaccines CDMO site in Suzhou, China. (Credit: Julia Koblitz on Unsplash)
WuXi Vaccines, a leading contract development and manufacturing organization (CDMO) focused on vaccine discovery, development, and manufacturing, has launched its first standalone vaccines CDMO site in Suzhou, China.
The opening will add drug substance and drug product capacity, with end-to-end services for diversified vaccines that will accelerate global clients’ project timelines – from process development and drug product development to clinical-scale drug substance (DS) and small-to-medium sterile drug product (DP) manufacturing. Its DS production area includes two cell culture lines and one purification line supporting DS production scales from 50L to 1,000L, while maintaining a reserved capacity for 2,000L production. The DP facility is equipped with an automatic vial washing, sterilizing, filling and capping line, which can support the clinical production of both liquid and lyophilized products.
Mr. Jian Dong, CEO of WuXi Vaccines, commented, “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. 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.”
The site currently employs 200 people and anticipates having more than 500 employees when it reaches full operation. The manufacturing of large-scale commercial lyophilized drug product in vials is expected to launch by the end of 2024.
The WuXi Vaccines facility in Dundalk, Ireland, recently achieved its notable milestone and will initiate Tech Transfer (TT). In addition, the facility has continued its commissioning qualification and validation (CQV) activities. The QC potency lab became operational in July 2020 and received its GMP certificate from the Ireland Health Products Regulatory Authority (HPRA) in July 2022. Currently, over 160 employees are working at the WuXi Vaccines Ireland site.
Source: Company Press Release