NanoViricides Inc. (NNVC)

[changes_iv]

If Nanoviricides, Inc. builds it, many will come...?

From the information that is widely available, About Nanoviricides, Inc. cGMP pilot plant...at the end are my observations and questions/speculation.

Nanoviricides, Inc. Retains AES Clean Technology, Inc. for Design, Engineering and Construction of the Cleanroom Suite in its previously announced cGMP Production and Laboratory Facility -- WEST HAVEN, CONNECTICUT -- January 14th, 2013

AES is the leader in turnkey design, manufacturing, and construction, of modular cleanroom systems (www.aesclean.com). Modular cleanroom technology delivers more speed, cleanliness, quality, and repeatable performance to the cleanroom project. AES is the leading vendor in cGMP-compliant manufacturing facilities for Pharmaceutical and BioPharma Manufacturing industries.

The Company has previously reported about the Shelton light industrial building that will house the cGMP pilot production plant, research laboratories, and offices. The cGMP pilot plant is being designed for the production of sufficient quantities of the drug needed for human clinical trials for each of the various nanoviricides® drug candidates as they advance into the clinical pipeline.

The light industrial building at 1 Controls Drive, Shelton CT was purchased by Inno-Haven, LLC. Inno-Haven is a private company that was founded by Dr. Anil R. Diwan, the Company’s CEO, and financed by himself and certain of his friends and associates, with the specific purpose of enabling clinical cGMP manufacturing capabilities for NanoViricides, Inc. drug substances. Acquisition of this 18,000 sqft building on 4.2 acres of land was previously announced by NanoViricides, Inc. in September, 2011. Renovation of the building is to be performed as per the requirements of NanoViricides, Inc. for the production of the nanoviricides drug candidates for clinical trials under cGMP processes. The drug substance produced in this facility will then be delivered to a third party for final processing and labeling, as required, for human clinical trials when ready. NanoViricides, Inc. expects to lease this facility. No lease has been signed yet and no terms of lease have been finalized as of now.

WHAT IS A PILOT PLANT

A pilot plant is a small industrial system which is operated to generate information about the behavior of the system for use in design of larger facilities.

Pilot plants are used to reduce the risk associated with construction of large process plants. They do this in two ways:

--> They are substantially less expensive to build than full-scale plants. The business does not put as much capital at risk on a project that may be inefficient or unfeasible. Further, design changes can be made more cheaply at the pilot scale and kinks in the process can be worked out before the large plant is constructed.

--> They provide valuable data for design of the full-scale plant. Scientific data about reactions, material properties, corrosiveness, for instance, may be available, but it is difficult to predict the behavior of a process of any complexity. Engineering data from other process may be available, but this data can not always be clearly applied to the process of interest. Designers use data from the pilot plant to refine their design of the production scale facility.

If a system is well defined and the engineering parameters are known, pilot plants are not used. For instance, a business that wants to expand production capacity by building a new plant that does the same thing as an existing plant may choose to not use a pilot plant.

Additionally, advances in process simulation on Mcomputers have increased the confidence of process designers and reduced the need for pilot plants. However, they are still used as even state-of-the-art simulation cannot accurately predict the behavior of complex systems.

Pilot plant is a relative term in the sense that plants are typically smaller than full-scale production plants, but are built in a range of sizes. Some pilot plants are built in laboratories using stock lab equipment. Others are constructed of fabricated metal on dedicated concrete slabs and cost millions of dollars.

After data is collected from operation of a pilot plant, a larger production scale facility may be built. Alternatively, a demonstration plant, which is bigger than a pilot plant, but smaller than the full-scale production plant, may be built to demonstrate the commercial feasibility of the process. Businesses sometimes continue to operate the pilot plant in order to test ideas for new products, new feedstocks, or different operating conditions. Alternatively, they may be operated as production facilities, augmenting production from the main plant.

Recent trends try to keep the size of the plant a small as possible to save costs. This approach is called miniplant technology. The flow chemistry takes up this trend and uses flow miniplant technology for small scale manufacturing.

source: http://en.wikipedia.org/wiki/Pilot_plant

A pilot plant can be used for:

Evaluating the results of laboratory studies and making product and process corrections and improvements.

Producing small quantities of product for sensory, chemical, microbiological evaluations, limited market testing or furnishing samples to potential customers, shelf-life and storage stability studies

Providing data that can be used in making a decision on whether or not to proceed to a full-scale production process; and in the case of a positive decision, designing and constructing a full-size plant or modifying an existing plant.

source: http://www.academia.edu/1745550/SCALEUP_TECHNIQUES_AND_PILOT_PLANT

The following called my attention:

1- The cGMP pilot plant is being designed for the production of sufficient quantities of the drug needed for human clinical trials for each of the various nanoviricides® drug candidates as they advance into the clinical pipeline.

2- Renovation of the building is to be performed as per the requirements of NanoViricides, Inc. for the production of the nanoviricides drug candidates for clinical trials under cGMP processes.

3- design changes can be made more cheaply at the pilot scale and kinks in the process can be worked out before the large plant is constructed.

4- Alternatively, they may be operated as production facilities, augmenting production from the main plant.

5- Recent trends try to keep the size of the plant a small as possible to save costs.

I speculate that Nanoviricides, Inc. will use the cGMP pilot plant to:

1- go from human trials (four phases...few short months), and after approval by FDA, to full production/commercial of FluCide and DengueCide from the cGMP pilot plant(~ 2H 2014) Possible?

2- DengueCide gets Priority Review Voucher (minimum $200 million) and sells it to another Pharma company (~ 2H 2014)

3- The PRV sale money is then used to finance a larger cGMP plant (~4Q 2014) -- see also --> http://www.bioprocessintl.com/journal/2008/February/Construction-and-Start-Up-Costs-for-Biomanufacturing-Plants-182238?pageNum=3

4- While the larger cGMP plant is under construction/integration, the PRV money is also used to take HIVCide-I and other Cides (perhaps two at a time), through parallel "fast tracks", tox studies, clinical trials and after FDA approval, market. (~3Q 2014)

5- The new larger cGMP plant is complete 4Q 2015

As we all know, Nanoviricides, Inc. has subcontracted several professional firms to perform key projects and then there is MPH Project Management Group/Engineering cost efficiently orchestrating/directing the cGMP plant to completion/integration/commission/validation/readiness.

Nanoviricides, Inc. has plans and they are on-track. Confidence is high on NNVC!