Biologics manufacturing facility
On 22 September, WuXi Biologics completed the first phase of development for a new perfusion biologics production plant in Wuxi City in China.
The new facility is Asia’s biggest biologics manufacturing facility and it meets the current good manufacturing practices (cGMP) standards of the US, EU, and China.
WuXi Biologics commenced construction on 30 April, 2015. The project was aimed to support the company’s biologics manufacturing pipeline and strengthen biologics discovery and development capabilities.
The new facility covers 460,000ft² and adds to the company’s existing production facilities in the area. It accommodates two 1,000l disposable bioreactors for perfusion processing of cell cultures and 14×2,000l disposable bioreactors for fed-batch processing.
Aseptic fill and finish and lyophilisation units at the facility support fully-automated drug product formulation and filling.
WuXi Biologics’ facilities at Wuxi City campus provide services such as process development, clinical and commercial drug substance manufacture, biologics manufacture, and antibody drug conjugates (ADC) development.
The existing facility was opened in October 2012. It was then the first of its kind in China to meet cGMP standards of the US, the EU, and China, as well as being the first to use disposable equipment for manufacturing biologics.
Clinical and commercial drug substance manufacturing facilities at the campus contain three production suites, which include cell expansion, cell culture, and purification units. These use disposable bioreactors and employ single-use or disposable technologies for upstream and downstream biologics manufacturing.
The facility also utilises three different cell culture technology platforms, fed-batch processing using single-use disposable bio reactors, concentrated fed-batch capability, and alternating tangential flow (ATF) system technology for perfusion cell culture.
The Wuxi City campus also includes antibody drug conjugate (ADC) development capabilities such as monoclonal antibody (mAb) discovery, engineering and production, bulk drug product formulation, antibody and payload conjugation, in-house assay development, and drug product fill/finish.
WuXi Biologics is a wholly-owned subsidiary of WuXi PharmaTech. It is a global contract services company providing drug discovery, development and manufacturing services to clients worldwide. Along with its affiliate WuXi AppTec, the company provides a single source contract development solution to global clients.
The company has three facilities in China at Shanghai, Wuxi, and Suzhou. These offer the open access technology platform, which allows the company to commercialise biologic drug forms.
The new perfusion biologics manufacturing facility in Wuxi City is an important milestone for the company, which will enable the commercialisation of the company’s robust biologics manufacturing pipeline and also meet the needs of Chinese companies.
WuXi Biologics has also opened a bio-manufacturing facility in Philadelphia in 2015. The facility supports the company to meet the needs of the cellular therapeutics US industry requirements. It will also help in further advancing the clinical studies and commercialisation of cell therapy products.
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