WuXi Biologics launches cGMP microbial products facility in Hangzhou

The WuXi Biologics MFG14 facility has been performing Chemistry, Manufacturing and Controls (CMC) projects since early 2022, and has now started current good manufacturing practice (cGMP) manufacturing of microbial products.

It is part of WuXi Biologics’ Integrated Innovation Centre, which was launched in November 2020 to offer products based on microbial fermentation technologies. Around 1000 scientists work at the 35,000 square metre innovation centre. 

“The fast growth of enzymes, plasmids, vaccines and biological therapies has driven the increasing demand for microbial fermentation capacity,” commented Dr Chris Chen, CEO of WuXi Biologics. “Over the past several years, WuXi Biologics has assembled an experienced team with in-depth expertise and insights for microbial-derived product modalities,.”

Specifically, WuXi Biologics has been working to incorporate expression systems such as Escherichia coli and yeast, which it says allow for “faster, more efficient and cost effective production across multiple modalities, including enzymes, antibody fragments, recombinant proteins, virus-like particle, and plasmid DNA.”

The launch of cGMP manufacturing at MFG14 will enable WuXi and its partners to “accelerate the development and manufacturing of these innovative products for the benefit of patients worldwide,” Dr Chen stated. 

Last month, WuXi Biologics launched its first commercial drug product facility for pre-filled syringes (PFS) in Wuxi, China. The DP5 facility has an isolator filling line for continuous and steady filling services for PFS of various volumes.

In 2021, WuXi Biologics achieved record growth and profitability, announcing revenues of RMB 10,290.1 million (up 83.3 percent year-on-year), as well as a gross profit of RMB 4,828.9 million (up 90.6 percent). The company, which employs some 10,000 people in China, the US, Ireland, Germany and Singapore, is predicted to have more than 10 percent share of the global biologics outsourcing market.