FDA Agreement on Mesoblast’s Use of Singapore Manufacturing Facility for MPCs Clinical Trial Production
News May 21, 2013
Mesoblast Limited has announced that United States Food and Drug Administration (FDA) is in agreement for Mesoblast to supply its proprietary Mesenchymal Precursor Cells (MPCs) for clinical trials in the United States under Investigational New Drug (IND) protocols, from Lonza's contract manufacturing facility in Singapore, in addition to its United States facility.
This follows the successful transfer of Mesoblast's MPC manufacturing process from the United States to the Singapore facilities of its contract manufacturer Lonza.
As the clinical indications pursued under IND by Mesoblast continue to broaden, particularly using intravenous delivery of MPCs for diseases of excessive inflammation and immunity, the Singapore facility will serve to support strategies for new product delineation.
As previously announced, the FDA has agreed that Mesoblast's manufacturing process is acceptable for Phase 3 clinical supplies. Mesoblast plans to use product manufactured in the Singapore plant in global Phase 3 trials.
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.
Itescu continued, “We anticipate that our operations in Singapore, where we maintain exclusive access to Lonza's manufacturing facilities for allogeneic cells, will expand in line with our growth in global capacity requirements for product supply, new product lines, and partnering strategies.”