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Tuesday, 15 January 2013
NanoViricides hires AES Clean Technology for pilot production and lab facility
Drug maker NanoViricides (OTCBB:NNVC) Monday announced that it has hired AES Clean Technology to design, engineer and construct the “cleanroom suite” for its laboratory and cGMP pilot production facility project.
The company’s cGMP (current good manufacturing practice) facility is being designed to produce sufficient quantities of the drugs needed for human clinical trials that will test various nanoviricide drug candidates as they advance into the clinical pipeline.
NanoViricides noted that the cleanroom suite makes up the main cGMP manufacturing sections of the pilot plant. The suite provides for walk-in, process scale, class 100 laminar hoods; walk-in, process scale chemical fume hoods; class 1,000 and class 10,000 work areas; entry airlock and egress systems.
"AES has the industry expertise in designing and building modular, validated, cGMP manufacturing suites for pharmaceutical industries," said president Anil R. Diwan, PhD.
"We are very pleased to have such experts working with us to enable this project in a cost effective fashion without compromising on quality or performance."
AES is known for turnkey design, manufacturing, and construction, of modular cleanroom systems. According to the AES website, modular cleanroom technology delivers “more speed, cleanliness, quality, and repeatable performance” to a cleanroom project.
Last month, NanoViricides announced that its cGMP facility will be built by renovating an existing 18,000 square foot light manufacturing plant on a 4.2 acre lot in Shelton, Connecticut.
While AES will be responsible for the cGMP manufacturing suites space, NanoViricides also recently hired ID3A architects as the principal architect for the project. The two companies join MPH Engineering, which will provide project management and engineering services.
The drug substances produced in the company’s new facility will be delivered to a third party for final processing and labeling, as required, for human clinical trials when ready.
The development-stage company is developing its NanoViricides class of drugs against a number of viral diseases including H1N1 swine flu, H5N1 bird flu, seasonal influenza, HIV, oral and genital herpes, viral diseases of the eye, Dengue fever, and Ebola virus, among others.
It is first focused on advancing its FluCide drug candidates through the regulatory process, and has already designed the toxicology and safety pharmacology studies for the IND submission and the first-in-human clinical trials of its FluCide investigational anti-flu product.
NanoViricides is now conducting further studies that are necessary before producing large batches for the safety and toxicology studies. The injectable anti-flu drug, NV-INF-1, is intended for use in hospitalized patients with the flu, and the company has said it could receive an orphan drug classification for use in immuno-compromised patients.
It has also developed an oral anti flu drug candidate, NV-INF-2, which it has said may be the "first ever nanomedicine drug of any kind that is active when administered orally."
The drug is being developed for out-patient flu cases, and may also be useful for influenza prophylaxis, as in use for the protection of health care workers.