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WuXi Vaccines Achieves GMP Release for First Drug Substance Facility in China

Friday, July 28, 2023

WuXi Vaccines announced the successful GMP (Good Manufacturing Practise) release for its first drug substance (DS) manufacturing facility in Suzhou, China. 

With the GMP release, the facility is now authorised to produce drug substances, and production has already commenced. The use of single-use bioreactors up to 1000L enhances both the efficiency and quality of drug substance manufacturing, enabling larger-scale production of vaccines.

The site is also expanding its manufacturing capabilities by developing drug substance capacity based on microbial and viral platforms up to BSL2. This will allow them to diversify their portfolio of vaccines and respond to different disease targets.

Additionally, it also plans to build a fill & finish facility. Fill & finish is the final step in the vaccine manufacturing process, where the vaccine product is put into its final containers, such as vials or syringes. This facility will offer various processes, including liquid, lyophilisation (freeze-drying), suspension, and emulsion, enabling the production of different types of vaccines.

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