WuXi Vaccines Clears First GMP Audit

WuXi Vaccines, a global vaccine CDMO, has successfully passed an on-site GMP audit by a global vaccine company at its first standalone CDMO site in Suzhou, China. The audit marks WuXi Vaccines’ first official client conducted GMP audit of the company’s quality system, meeting GMP standards and industry benchmarks.

The three-day audit covered the 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.

Jian Dong, CEO of WuXi Vaccines, said, “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.”