SUZHOU, China, Dec. 6, 2023 /PRNewswire/ — WuXi Vaccines, a leading global vaccine CDMO (Contract Development and Manufacturing Organization), today announced it has successfully passed an on-site GMP audit by a global vaccine leader at its first standalone CDMO site in Suzhou, China. The audit marks WuXi Vaccines’ first official client-conducted GMP audit, a signifier that the company’s quality system is in accordance with global GMP standards and meets the highest industry benchmarks.
The three-day comprehensive audit covered the CDMO site’s drug substance (DS) facility, drug product (DP) facility, QC laboratories, warehouse, and utilities, as well as the quality system. It resulted in no critical observations and will allow WuXi Vaccines to proceed with GMP manufacturing for the client’s projects.
Mr. Jian Dong, CEO of WuXi Vaccines, commented, "We’re glad to have successfully passed the first GMP audit by a global vaccine leader, which not only reflects WuXi Vaccines’ unwavering commitment to excellence, but also demonstrates the recognition we receive from clients as a trusted partner in the vaccine industry. While adhering to the highest standards, we will continue to leverage our flexible project management and extensive capacity to enable global partners to advance their pipelines, with the ultimate goal of improving the well-being of people worldwide."
WuXi Vaccines’ Suzhou site – launched in September this year – provides global clients with services that include process development and drug product development, clinical-scale DS, and small-to-medium sterile DP manufacturing.
About WuXi Vaccines
WuXi Vaccines is a leading contract development and manufacturing organization (CDMO) that focuses on vaccine development and manufacturing. It provides world-class, integrated development and manufacturing platforms to expedite partners’ vaccines to the clinical stage and the market, regardless of the vaccine modality (i.e., recombinant protein, viral, viral vectored, VLP, OMV, nucleic acid, conjugated vaccines). With its technical expertise, broad regulatory knowledge, premium quality system, advanced CMC development capabilities, multiple production platforms (cell culture, viral, microbial, polysaccharide and protein conjugation), and extensive GMP manufacturing capacities, WuXi Vaccines provides an end-to-end service – from vaccine discovery and development to large-scale commercial production and distribution. The company can enable global clients to deliver critical vaccines anywhere in the world, making it an essential partner in protecting public health. For more information about WuXi Vaccines, please visit: https://wuxivaccines.com