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January 27, 2014
07:04 EDTNNVCNanoViricides reports R&D Lab, cGMP facility near construction completion
NanoViricides reported that construction of the modern R&D Lab and cGMP Clinical Production facility in Shelton, Connecticut, is nearing completion on schedule. The company reports that the R&D lab section of the facility is nearing completion, slightly ahead of schedule. In addition, construction of the cGMP Clean Room Production Suite is expected to be completed in March, 2014, on schedule, and shortly thereafter, the project will enter facility testing and validation phase. After construction is complete, the facility, and particularly the cGMP Clean Room Suites will undergo facility testing and validation to ascertain that the facility satisfies the requirements. After validation, the company plans to occupy the new facility while keeping the current facility active to minimize impact on the multiple nanoviricides® drug development projects. The company intends to first start production of FluCide in the cGMP section, set up appropriate cGMP operation for this production, produce multiple batches of FluCide under cGMP conditions, and demonstrate equivalence of the batches produced, in preparation for human clinical trials.
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