WuXi Vaccines Passes First GMP Audit by a Global Vaccine Leader

07 December 2023 | Thursday | News

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.
Image Source : Public Domain

Image Source : Public Domain

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.


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