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news.WuXi XDC has launched new commercial Good Manufacturing Practices (GMP) facilities in Wuxi, Jiangsu Province, China.
Opening of the new commercial Good Manufacturing Practices facilities. Credit: WuXi XDC.
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With an area of around 7,000m2, the new location features the XBCM2 dual-function facility for bioconjugate drug substance and antibody intermediates production.
It also comprises the XDP2 facility, which is suitable for bioconjugate drug production, and includes testing and commercial packaging spaces.
Featuring automated systems and advanced equipment, the two facilities offer comprehensive one-stop GMP manufacturing services for antibody drug conjugates (ADCs) and other bioconjugates at the clinical as well as commercial stages.
The XBCM2 facility provides end-to-end manufacturing services ranging from monoclonal antibody intermediates to ADC drug substances.
It can produce monoclonal antibody intermediates in batch sizes ranging from 200 to 2,000 litres, for both upstream cell culture and downstream protein purification processes.
The two independent ADC drug substance production lines can fulfil the need for manufacturing ADC drug substance of up to 2,000 litres.
The XDP2 facility features advanced isolator aseptic filling technology and a single-use filling system with on-line 100% drug weighing and a complete product testing function.
With fully automated commercial packaging capability, the facility offers complete production capacity for potent and aseptic products.
It can manufacture liquid and lyophilised formulations ranging from 2R to 50R in size, achieving an annual production capacity of five million vials.
WuXi XDC CEO Dr Jimmy Li said: “The new facilities further expand our capacity and bolster our comprehensive one-stop GMP capability, providing stronger support to meet our clients’ demands in development and manufacturing.
“Meanwhile, our Singapore manufacturing facility is under design, which will further expand our capacity and enhance WuXi XDC’s global presence.”
