NanoViricides Inc. (NNVC)

[changes_iv]

NanoViricides, Inc. is in the process of commissioning operations at the new cGMP Pilot Plant facility in order to perform the scale up studies needed for making the large quantities of FluCide materials in a controlled manner. These upcoming studies will be performed in cGLP compliant manner to provide safety and toxicology data that are required for an IND submission to regulatory agencies. The Validation/Qualification definition emphasizes product; the Commissioning def. emphasizes equipment.
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We are now progressing to a 1kg scale-up of FluCide, and enabling in-process control instrumentation. We need to make approximately 2.5Kg of our FluCide drug candidate for further Tox Package studies because of the excellent safety demonstrated by this drug candidate in safety and toxicology studies in both mouse and rat animal models. CMC stands for "Chemistry, Manufacture, and Controls," and relates to being able to make the drug substance and the drug product in a reproducible fashion, batch after batch. CMC programs for nanomedicines are relatively complex compared to those of small molecules. We have focused on developing scalable, reproducible processes from the very onset, which has helped us minimize the process development time.
http://www.prnewswire.com/news-releases/nanoviricides-files-quarterly-report-for-period-ending-2015-03-31-300084664.html

And if the nanoviricides(R) are bioequivalent, once you get the scale-up recipe for FluCide(TM), the recipe for other nanoviricides(R) won't be far off, or will they?
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About Microfluidics and Nanofluidics...


Scaleup with Repeatable Results

Achieving results in the lab is a critical step, but for most commercial applications it is only valuable if the results can be reproduced in a production environment. Every model in the Microfluidics product line is engineered with the end result in mind. By utilizing a linear scaleup method of the fixed-geometry interaction chambers, customers using Microfluidizer processors in the lab are guaranteed to attain the same repeatable and predictable results when scaling up to production volumes.
http://www.microfluidicscorp.com/applications/biotechnology/52
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Of course, achieving success in the lab is only valuable it can be repeated reliably, regardless of scale. Microfluidics further differentiates from other technologies in that not only are results repeatable from batch to batch, but also from lab environments to pilot and production volumes. This is achieved by aligning microchannels in parallel within the interaction chamber, with a a single output reservoir. This essentially ensures the entire product stream experiences identical shear, resulting in consistent quality no matter the volume, from 1 mL (with the new LV1 low volume machine) up to 60 liters-per-minute.
http://www.microfluidicscorp.com/our-technology/how-it-works