WuXi Biologics has announced the launch of WuXi Vaccines, a joint venture with Hile Bio-Technology of Shanghai. The companies have entered into the strategic partnership via a Letter of Intent (LOI) under which WuXi Vaccines will build a dedicated facility and supply a commercial product for the global market.
The business model of WuXi Vaccines is to build world-class integrated platforms and CDMO model to enable global companies to develop and manufacture vaccines.
Under the LOI, WuXi Vaccines will build an integrated vaccine manufacturing facility. The project comprises drug substance manufacturing (DS), drug product manufacturing (DP) as well as Quality Control labs (QC).
The facility will be dedicated to manufacturing 100% of the global market of one of WuXi’s partner vaccine products. The company has signed a 20-year manufacturing contract that is estimated to be more than US$3 billion.
Commenting on the news, Dr Chris Chen, Wuxi Biologics CEO, said: "Vaccine CDMO is one of the next growth areas for WuXi Biologics. Once this project is initiated, our vaccine business will contribute substantially to the growth of the company."
Dr Chen explained that due to process complexity, extensive analytic testing and rigorous regulatory standards, vaccines are difficult to manufacture and process and quality control are extremely critical for the quality of the product. "This partnership to exclusively manufacture a vaccine for the global market, first of its kind in the industry, is further testimony to the technical strengths and premier quality demonstrated by WuXi Biologics,' Dr Chen added.
Shanghai Hile Bio-Technology is principally engaged in the research and development, production and sales of veterinary biological products. Its product portfolio is commercialised mainly in China.
New biologics manufacturing plant in Chengdu
The launch of WuXi Vaccines comes after a week of announcing the construction of a new 1.3 million sqft manufacturing centre for innovative biologics in Chengdu, one of the largest cities in Southwest China.
Render: WuXi Biologics Integrated Manufacturing Centre for Innovative Biologics
The facility (render picture above) will house the 12th drug substances manufacturing facility (MFG12) of WuXi Biologics.
This new integrated manufacturing centre will include drug development and commercial manufacturing facilities with an initial bioreactor capacity of 48,000 L.
WuXi Bio is the first biologics company in China passing both the US FDA and EMA GMP inspections and has said it will apply its expertise and quality system at this new integrated manufacturing centre.
The new site will enable more global partners, create more jobs for local talents, stimulate high growth of the biologics industry in Chengdu as well as accelerate the biologics ecosystem in Southwest China.