First Chinese biologicals maker receives EMA GMP certification

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China-based WuXi Biologics announced on 20 March 2019 that it had received good manufacturing practice (GMP) certification from the European Medicines Agency (EMA).

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The certification covers the production of Trogarzo (ibalizumab-uiyk) at its current good manufacturing practice (cGMP) drug substance and drug product manufacturing facilities in Wuxi and its cGMP cell banking facilities in Shanghai. Trogarzo was developed by TaiMed Biologics and is marketed in the US and Europe by Theratechnologies.

The approval certifies compliance with GMPs including manufacturing of biological medicinal/biotechnology products; biological active substances and dosage forms containing biological active substance; quality control testing and packaging operations. The certificate demonstrates that the company’s manufacturing practices consistently meet the required quality standards.

In 2018, WuXi Biologics announced significant expansions in its biologicals manufacturing facilities. These included investments in a new biologicals drug substance manufacturing facility in Dundalk, Ireland and plans to build an integrated biologicals development, clinical and commercial manufacturing centre in the city of Shijiazhuang, China [1].

The company says that its ‘world-class facilities’ enable it to ‘simultaneously advance in parallel the development and registration of innovative biologic[al]s and biosimilars for both China and the overseas market’.

This certification by EMA ‘marks yet another great milestone that WuXi Biologics has achieved and lays a solid foundation for us to significantly expand our manufacturing capacity and capabilities’, according to Dr Chris Chen, CEO of WuXi Biologics. He added that ‘with the recognition from both the US Food and Drug Administration (FDA) and EMA, WuXi Biologics will continue to enable our global partners to accelerate and transform biologic[al]s development from concept to commercialization’.

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1. GaBI Online - Generics and Biosimilars Initiative. WuXi Biologics expands its biologicals manufacturing facilities []. Mol, Belgium: Pro Pharma Communications International; [cited 2019 May 3]. Available from:

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Source: Wuxi Biologics

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