NanoViricides Inc. (NNVC)

[changes_iv]

...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.nanoviricides.com/press%20releases/2015/NanoViricides%20Provides%20an%20Update%20on%20Its%20Progress%20over%20the%20Last%20Quarter.html

In another news, the Company reports that the process of commissioning of its new facility in Shelton is on course. Our Bio-Analysis Group has already moved operations to the new facility. Large Scale Chemistry Group is completing the necessary modifications to the facility to enable large scale production processes. Various laboratory instruments are being installed by vendors under warranty programs for installation qualification and operational qualification.

http://www.nanoviricides.com/press%20releases/2015/NanoViricides%20Discusses%20the%20Strong%20Effectiveness%20of%20Its%20Anti-Herpes%20Drug%20Candidates%20in%20a%20Lethal%20Animal%20Model%20of%20Dermal%20Herpes%20Infection.html

No, I don't know of any connection between the companies and NanoViricides, Inc. however, we all know NanoViricides, Inc. is not in the business designing/manufacturing lab instruments/equipment. Whatever technology/instruments/equipment NanoViricides, Inc. is employing to scale up it must be guaranteed to scale up. If it is not Microfluidics Corp. then it is about other competing technology/equipment/instruments employed for scale up synthesis of their therapeutic drugs.

For example, from Microfluidics Corp.

Narrow Nanoparticle Distribution

Uniformity of particle size is equally important in process performance. Microfluidizer® homogenization equipment excels at generating the narrowest particle size distribution results possible, thanks to stable pressure and constant volume processing at pressures up to 40,000 pounds per square inch. This leads to improved product stability and extended shelf life – and may significantly improve yield of active ingredients post filtration/sterilization to reduce costs associated with production.

Guaranteed Scalability

Attaining unprecedented particle size reduction and a uniform distribution is one thing, but scalability is often another. We guarantee seamless scale-up with unique parallel path micro-channel architecture to achieve consistent process performance and repeatable results; not only from batch to batch, but also from lab environments to pilot and production facilities.

http://www.microfluidicscorp.com/

Rob Lee, VP of Particle Sciences makes reference to particle size characterization and/or formula characterization. NanoViricides, Inc. has made reference in PR about a Large Scale Characterization Group at the new Shelton pilot plant. They work with companies like MicroFluidics Corp. on how to improve their equipment or increase capabilities of their equipment.

From another website:

Q: What are the characterization methods of nanoparticles synthesized...how do we know that the nanoparticles have been synthesized?

Is it a chemical, physical or biological method?
...
A: João Conde · Massachusetts Institute of Technology
Atomic Force Microscopy (AFM), Scanning Electron Microscopy (SEM), Transmission Electron Microscopy (TEM), Light-Scattering microscopy, FT-IR, Zeta potential, Dynamic Light Scattering (DLS), Fluorescence, UV-VIS molecular absorption, etc....

NanoViricides, Inc. is not alone in their objective to scale up cGLP and cGMP.

Scale-up of the FluCide™ anti-influenza drug candidate is progressing well. We are continuing the CMC studies (see below) on FluCide production processes. These studies are necessary to enable further scale-up from the current multi-100g scale of production to kg-scale production of our nanoviricides drug candidates. The 1kg-scale production is being set up at our new Shelton, CT facility and headquarters.
...
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