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news.The FDA has agreed on the use of Mesoblast's Singapore manufacturing facility for production of proprietary mesenchymal precursor cells (MPCs) required for Phase 3 clinical trials.
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Mesoblast will supply MPCs manufactured at Singapore manufacturing facility of its contract manufacturer, Lonza, besides at its US facility.
Mesoblast chief executive Professor Silviu Itescu said, "Having multiple geographic sites to manufacture our MPC products to FDA compliance is an integral part of Mesoblast’s corporate strategy for product delineation, and offsets risks of single site dependence."
New facility is expected to support product delineation strategies, increase geographical reach and reduce risk associated with single site reliance.