NanoViricides Inc. (NNVC)

[changes_iv]

First, you must own-up to the fact that the new state-of-the-art multi-kilogram Pilot Plant is key to the success/commercialization of NanoViricides, Inc. therapeutic drugs.

Abstract: ...The preparation of several clinical batches in the pilot plant provides its personnel with the opportunity to perfect and validate the process. Also different types of laboratories have been motivated to adopt new processes and technologies in an effort to stay at the forefront scientific innovation.

Introduction: Pharmaceutical pilot plants that can quickly numerous short-run production lines of multiple batches are essential for ensuring success in the clinical testing and bougainvilleas study phases. Drug formulation research time targets are met by having a well-designed facility with the appropriate equipment mix, to quickly move from the laboratory to the pilot plant scale 1. In pilot plant, a formula is transformed into a viable, robust product by the development of a reliable and practical method of manufacture that effects the orderly transition from laboratory to routine processing in a full scale production facility where as the scale up involves the designing of prototype using the data obtained from the pilot plant model. Pilot plant studies must includes a close examination of formula to determine its ability to withstand batch-scale and process modifications; it must includes a review of range of relevant processing equipment also availability of raw materials meeting the specification of product and during the scale up efforts in the pilot plant production and process control are evaluated, validated and finalized. In addition, appropriate records and reports issued to support Good Manufacturing Practices and to provide historical development of the production formulation, process, equipment train, and specifications2. A manufacturer’s decision to scale up / scale down a process is ultimately rooted in the economics of the production process, i.e., in the cost of material, personnel, and equipment associated with the process and its control.

http://www.kppub.com/articles/jan2012/a_review_on_pilot_plant_scale-up_techniques.html

NanoViricides, Inc. is no longer releasing news about "scale-up studies" and that is because...
-we are done with scale-up studies for now, and scale-up studies for 5kg will come later, likely after a Clinical Trials phase
-we commissioned the new state-of-the-art multi-kilogram Pilot Plant in Shelton, CT, to produce FluCide(TM)/GLP, sometime in early Jan 2015
-Mar 31, 2015 - We are now progressing to a 1kg scale-up of FluCide, and enabling in-process control instrumentation--- CMC studies to enable further scale-up from the current multi-100g scale of production to kg-scale production. 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.
-We are now making the FluCide(TM) material for Phase III in large animals!

June 1, 2015, 9:47 PM

FluCide

Phase I and II of tox successfully completed

Making material for last Phase in large animals

MersCide

Waiting for Public Health England to request the drug (sitting on the shelf) for testing. They got distracted by the Ebola outbreak

EbolaCide

Making more drug for continuation of the testing by USAMRIID

Had FluCide not turned out to be so incredibly safe, we would have been done with tox by now. Incredibly safe is not a bad thing at all!

Eugene Seymour MD MPH
Chief Executive Officer
NanoViricides, Inc
[e-mail]
www.nanoviricides.com
310-486-5677
"NNVC" on the New York Stock Exchange

The next PR is coming! When? As The Patriot once said: Soon!