NanoViricides Inc. (NNVC)

[changes_iv]

On Apr 6, 2015...

We are now working to optimize all of the processes involved in the production of FluCide. Equipment needed for this task is being acquired, and is being installed by factory representatives as it arrives. Some items have lead times of 6 to 8 weeks for delivery. We are working as quickly as possible on setting up the production processes at our new state of the art c-GMP-capable manufacturing facility in Shelton, CT.

We are happy to announce that our Biological Characterization Group has now completely moved to our Shelton, CT campus. We are implementing a phased move to Shelton so that there is minimal impact on our continuing operations. We plan on continuing to use our West Haven facility to maximize R&D efforts on our large number of drug development programs.
http://www.prnewswire.com/news-releases/nanoviricides-provides-an-update-on-its-progress-over-the-last-quarter-300061129.html

On May 18th, 2015...

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.nanoviricides.com/press%20releases/2015/NanoViricides%20Files%20Quarterly%20Report%20for%20Period%20Ending%202015-03-31.html

[We have likely developed the 500g scale-up recipe for FluCide (TM), and now the 1kg scale-up recipe. Can we say we are now making material, the first of identical batches of 1kg for the last phase of tox studies 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

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Miniaturized lab-on-a-chip methods are being deployed as labor-saving devices in biological research, through the advent of a suite of microfluidics technologies. Microfluidics enables large-scale studies that provide the means to better understand, prevent, and treat human disease. In his 2012 Midsummer Nights' Science lecture, Paul Blainey discusses the promise of using microfluidics to transform our industrial infrastructure to operate more efficiently, while protecting the natural environment.

New Alliance Between Microfluidics And Particle Sciences Expands Reach Of Microfluidizer® Technology

Microfluidics and Particle Sciences collaborate to extend the application, expertise and support of unique high shear fluid processors.

[4/06/2015] — Westwood, MA — Microfluidics, exclusive global creator of Microfluidizer® high shear fluid processors, is now partnering with Particle Sciences, Inc., a leading contract development and manufacturing organization (CDMO). This new alliance is designed to give the companies more ways to serve their clients with complex formulation development as well as lab support testing services in Pharmaceutical and Biopharmaceutical processing.

“Particle Sciences has been a good partner in the past, making our decision to work more closely with them an easy one,” said Brad Besse, Business Unit Director at Microfluidics. “They have shown themselves to be leaders in nanoparticle production, specifically with our technology.”

CEO at Particle Sciences, Dr. Mark Mitchnick, added, “Particle Sciences is the leading CDMO for nano-based products. We have worked with Microfluidics since before their acquisition by IDEX, and already have several machines installed. We are seeing an increasing need for the highly consistent performance Microfluidizer® technology is able to deliver. This, combined with Particle Sciences’ deep understanding of the technology and our base capabilities in characterization and sterile production is driving the relationship expansion. We have formulated multiple products with Microfluidizer® technology, recently manufacturing 120L of a sterile emulsion for a client using the equipment and have several more in the pipeline.”

Besse also said he believes “that by working together, both parties can expand their application expertise and support services to better serve our customer needs. In addition to formulation and clinical trial production, Particle Sciences affords our customers the ability to work with highly potent compounds under cGMP guidelines, in a purpose-built facility.”

Microfluidics is the exclusive producer of Microfluidizer® high shear fluid processors for uniform particle size reduction, robust cell disruption and nanoparticle creation. The innovative Microfluidics Technology Center, located at the Company’s headquarters outside Boston, Massachusetts, is staffed by expert engineers with a wide range of nanotechnology and application experience for proof-of-concept and process development support. Microfluidizer™ technology enables companies to create tiny particles that achieve big results. To learn more, please visit www.microfluidicscorp.com, email [e-mail] , or contact us at [phone].

Particle Sciences is an integrated provider of drug development services. Particle Sciences focuses on BCS II/III/IV molecules, biologics and highly potent compounds through a variety of technologies including emulsions, gels, micro and nano-particulates, drug/device combination products, solid solutions and others. Through a full range of formulation, analytic and manufacturing services, Particle Sciences provides pharmaceutical companies with a complete and seamless development solution that minimizes the time and risk between discovery and the clinic. They also have an extensive history in government contracting alongside their customers...
http://www.microfluidicscorp.com/latest-news-a-events/200-new-alliance-between-microfluidics-and-particle-sciences-expands-reach-of-microfluidizerr-technology