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Suzhou, China, March 1, 2024 – WuXi Vaccines, a world-leading vaccine Contract Development and Manufacturing Organization (CDMO), announced that its Suzhou site has passed the recent Qualified Person (QP) audit, affirming the site’s compliance with the European Union Good Manufacturing Practices (EU GMP) and the requirements of EU GMP Annex 1 (Manufacture of Sterile Medicinal Products), which came into operation in August 2023.

Having fulfilled EU’s GMP requirements reflects WuXi Vaccines’ commitment to maintaining the highest standards of manufacturing quality and positions the company as one of the pioneer vaccine manufacturers to meet EU GMP requirements.

The audit, spanning three days, thoroughly evaluated various facets of WuXi Vaccines’ Suzhou site, including the drug substance facility, drug product facility, QC laboratories, warehouse and clean utilities, resulting in no critical or major observations.

“We are proud of this significant milestone, which underscores our dedication to regulatory excellence and continuous improvement,” said Mr. Jian Dong, CEO of WuXi Vaccines. “By successfully aligning with EU GMP and Annex 1, we reinforce our position as a trusted and quality-driven partner to enable our clients to provide safe and effective vaccines worldwide, contributing to global public health efforts.”

According to EU regulations, medicinal products shall be certified by QP in accordance with GMP requirements before they can be released for sale or supply to the EU market. The Annex 1 of EU GMP provides specific guidance on the manufacture of sterile medicinal product with a strong focus on risk management and contamination control strategy.

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.

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