WuXi begins US plant
pharmafile | May 2, 2014 | News story | Manufacturing and Production | CMO, China, NY, Shanghai, US, WuXi, pharmatech
Contract manufacturing organisation WuXi PharmaTech has begun work on a new facility in Philadelphia’s Navy Yard for the production of cell therapies, giving it a greater foothold in the US market.
The Chinese group, which provides laboratory and manufacturing services to the pharma and biotech industries, announced that it has broken ground on the new plant and expects it to be operational in the second quarter of next year.
“Cell therapies offer important treatment options, and WuXi is committed to bringing them to patients faster,” says Ge Li, chairman and chief executive of PharmaTech.
The 45,000 square foot facility will be used for clinical and commercial manufacturing space and will boast flexible clean room technology, disposable equipment, and microcarrier cell culture systems.
WuXi already has a 16,000 square foot cGMP cell therapy manufacturing facility in Philadelphia, whose services include analytical chemistry, cell banking, cell characterisation, molecular biology and lot release testing.
WuXi says: “This expansion will support growing customer demand with single-source contract development and cGMP manufacture capabilities for allogeneic and autologous cell-based therapeutics.”
Headquartered in Shanghai, WuXi has been forging ahead in this field. In 2013 it opened a Shanghai plant with 500L and 1,000L single-use bioreactors and, a few months ago, completed the first production test run in its pair of disposable 2,000-litre cell culture bioreactors installed there.
This provides further evidence that single-use technology is now fully industrialised in the biopharma sector: the two bioreactors produced batches of an antibody drug called ibalizumab, a CD4 entry inhibitor in development as an HIV treatment at Taiwanese biotech company TaiMed Biologics.
The test run was made using an NS0 mouse myeloma cell line and WuXi called it a milestone “in the global biologics manufacturing industry”.
Ge Li has called biologics manufacturing a ‘unique opportunity’ for the company because it can offer accelerated access to the Chinese market thanks to WuXi’s integrated biologics drug discovery and development capabilities, state-of-the-art production facilities and relevant regulatory approvals.
Adam Hill
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