Replies to post #65926 on NanoViricides Inc. (NNVC)

[Puffer]

HuffAz -

They have decided to build this capability internally --

(From Diwan, early Feb)

We have made a diligent effort since founding to find a facility where we could get our drugs made without going through the time and expense of building one ourselves. Our nanoviricides® drugs are defining the cutting edge of pharmaceutical technology. Such products have never been made before in the pharmaceutical arena as drugs. Thus we found that the expertise for translating our technology into a manufacturing process with appropriate controls is rare in contract manufacturing organizations (CMOs). In addition, our negotiations with certain CMOs demonstrated to us that any CMO would need to put in specialized equipment for our processes, and the cost of the equipment design and engineering, process design and engineering, as well as the cost of all custom modifications to their facilities and the custom equipment, would be passed on to NanoViricides, Inc. We also found out that a small nimble company like ours can find ways to do these things at a much lower cost than a medium or large CMO.

The FDA cGMP guidelines (and similar international guidelines, as well as the ICH) put substantial constraints on what the facility needs to have. These guidelines pertain to air quality in various operation rooms, sequestration of operations, personnel access systems and control, process documentation procedures and documentation, quality control procedures and documentation, among other things. The implementation of such guidelines has been formalized to a great extent in the industry. It became clear to us, after discussions with several industry experts, that the fastest and least expensive way of developing cGMP capability for our drugs would be to completely renovate an existing building of a suitable size.