WuXi Biologics Adds Microbial Fermentation to CDMO Offering in Hangzhou
WuXi Biologics is expanding its CDMO services to include microbial fermentation in its MFG14 facility in Hangzhou, the capital of China’s Zhejiang province. The plant has been performing CMC (chemistry, manufacturing and controls) services for clients since early 2022, said the company.
Plans for introducing a microbial CDMO platform have been underway since 2019. In November, WuXi launched the Biologics Integrated Innovation Center in Hangzhou for end-to-end services for microbial-derived biologics.
Microbial Fermentation and Processes
Many therapeutic products, ranging from anticancer drugs and vaccines to hormonal therapies such as insulin can be produced via microbial fermentation. The process uses microorganisms such as E. coli and yeast, and is fast, cost-effective and easy to scale-up. According to WuXi, the Hangzhou plant can produce enzymes, antibody fragments, recombinant proteins, virus-like particles, and plasmid DNA.
WuXi’s platform provides the full course of CMC services, from strain development, process and analytical development, to cGMP manufacturing and QC release. Production is enabled by four cGMP manufacturing lines equipped with 30L to 2,000L fermentors, and is complemented by downstream processing capacities, drug substance formulation and filling capabilities.
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A Global CDMO With Ever-Growing Appetite
WuXi Biologics has a presence in many countries including China, the US, Ireland, Singapore. More recently, the company expanded into Germany by acquiring two drug plants owned by Bayer.
Besides the microbial-focused facility, the company has another biosimilar manufacturing plant in Hangzhou it acquired from Pfizer in 2021, after the drug giant decided to exit the Chinese biosimilar market despite major investments in the area.
Elsewhere in China, WuXi Biologics acquired a biologics manufacturing site in Suzhou from CMAB, and maintains operational sites in Shanghai, Wuxi and Suzhou. Meanwhile, sites in Shijiazhuang and Chengdu are expected to begin operations in 2022 and 2023 respectively.
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