05 July 2022 | Tuesday | News
Image Source : Public Domain
WuXi Biologics ("WuXi Bio") (2269.HK), a global leading Contract Research, Development and Manufacturing Organization (CRDMO), announced that its MFG14 facility in Hangzhou has been released for manufacturing microbial-derived products. The facility has been successfully performing CMC projects for multiple clients since early 2022, reflecting the company's demonstrated abilities to provide services from DNA to cGMP manufacturing for products derived from microbial fermentation.
WuXi Biologics' established microbial platform provides end-to-end CMC services – including strain development, process and analytical development, cGMP manufacturing, and QC release – at centralized facilities that are all located within the company's Biologics Integrated Innovation Center in Hangzhou. The MFG14 facility contains four cGMP manufacturing lines equipped with 30L to 2,000L fermentors, and has matching downstream processing capacities, as well as drug substance formulation and filling capabilities. The facility is designed to be highly flexible to meet a variety of customers' needs.
In response to growing market demand, WuXi Biologics has been strengthening and expanding its integrated technology platforms, incorporating the use of microbial expression systems such as E. coli and yeast, which allow faster, more efficient and cost-effective production across multiple modalities, including enzymes, antibody fragments, recombinant proteins, virus-like particle (VLP), and plasmid DNA.
"The fast growth of enzymes, plasmids, vaccines and biological therapies has driven the increasing demand for microbial fermentation capacity," said 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. Now with the successful initiation of cGMP manufacturing at the MFG14 facility in Hangzhou, our end-to-end microbial services will enable our partners to accelerate the development and manufacturing of these innovative products for the benefit of patients worldwide."
In November 2020, WuXi Biologics launched the Biologics Integrated Innovation Center in Hangzhou, Zhejiang Province, China to provide full-spectrum services for next-generation biological products that are based on microbial fermentation technologies.