NanoViricides Inc. (NNVC)

[changes_iv]

FN, from your email exchange with Dr. Seymour...

Look at what we're doing

I'm here in Europe to finish the H7N9, H5N1 and MERS contracts with both European groups. We're working with Eva Harris on Dengue, and finishing our herpes work at the medical school in Ohio! As soon as the genital herpes work us completed, we will do our confirmatory ophthalmic herpes studies.

The plant is almost done and the scale-up is well underway in the current labs

Preliminary tox studies showed absolutely no evidence of toxicity and we're preparing product for the large-scale tox studies at BASI.

I couldn't be more excited about our prospects, ~ Dr. Eugene Seymour, CEO NanoViricides, Inc.

The non-GLP safety and toxicology study was begun in late September at KARD Scientific in Massachusetts. The results of this study will provide the basis and focus for the IND-enabling GLP safety and toxicology studies of FluCide that are required for the IND submission to the U.S. FDA. These IND-enabling GLP safety and toxicology studies will be performed by BASi Toxicology Services in West Lafayette, IN. The Company has previously reported that its FluCide candidate was highly effective in animal models of different influenza A virus strains. In those efficacy studies of FluCide, no safety or toxicology concerns were observed. As a result, the required quantity estimated for GLP safety/tox study is much larger than our current synthesis capability. The Company has undertaken process development, scale-up, chemistry optimization and control program to enable large scale synthesis of FluCide in a reproducible manner. This work is currently in progress.

The small company is working with Eva Harris on Dengue(DengueCide) and scale-up is well underway in the current labs. They are preparing product for tox studies at BASI,...GMP-like, in a reproducible manner or batches. I'd like to believe, that if they are preparing product for tox studies at BASI is because they are done with process development [above in red], it is now being prepared at the lab and IMO it is being supplied to BASI. Who knows? Maybe weeks ago!

The GLPs are designed to protect scientific data integrity, and to provide EPA or FDA with a clear and auditable record of open-ended research studies. In contrast, the GMPs are intended to demonstrate to FDA whether or not individual batches of a regulated product are manufactured according to pre-defined manufacturing criteria.

"We are doing all of the preparatory pre-tox work now and the formal tox studies by BASI will start as soon as the pre-tox work is done and an [sic] sufficient amount of material is available from the existing lab

We're estimating a June start though that could go either way by 2-3 months depending on both BASI's schedule and ours." ~ Dr. E. Seymour, CEO NanoViricides, Inc.

However, we cannot tell with certainty if the tox studies have begun. They may have. Others with greater resources (competition) may find it difficult to pin-point the start as well. We may all get surprised with news that read like this, NanoViricides, Inc. Reports Excellent Safety Profile of Its Broad-Spectrum anti-Influenza Drug Candidate, FluCide™ , but this time in a GLP Study.

other sources: GLP vs GMP

Good manufacturing practice is the part of quality
assurance which ensures that products are consistently
produced and controlled to the quality standard appropriate to
their intended use and as required by the Marketing
Authorization or product specification.

http://www.pda.org/Chapters/North-America-cont/Southeast/Presentations/GLP-vs-GMP-vs-GCP.aspx

Laboratory-scale batches. These are produced at the research and early development laboratory stage. They may be of very small size (e.g., 100–1000 times less than production scale). Laboratory-scale batches may be used to support formulation and packaging development, early clinical and/or preclinical stages. Laboratory-scale batches can also be analyzed to assist in the evaluation and definition of critical quality attributes (CQAs). A CQA is a physical, chemical, biological, or microbiological property or characteristic that should be within an appropriate limit, range, or distribution to ensure the desired product quality. CQAs are generally associated with the drug substance, excipients, intermediates, and drug product.

Pilot-scale batches. These may be used in the process-development or optimization stage. They may be used to support preclinical and mid- to later-stage clinical evaluation and also to support formal stability studies. If supporting formal registration, a pilot-batch size should correspond to at least 10% of the production-scale batch. For oral solid-dosage forms, this size should generally be 10% of production scale or 100,000 units, whichever is greater. The choice of pilot scale is often difficult for the project team as members must balance parameters such as anticipated product volumes, anticipated site of production, equipment constraints at that site, and regulatory expectations. With the increasing trend toward developing orphan drugs, the authors believe that the regulatory expectation of pilot-scale batches of 100,000 units is not always valid and should be discussed with the relevant regulatory authority.

source: Strategic Approaches to Process Optimization and Scale-up
http://www.pharmtech.com/pharmtech/Online+Exclusives/Strategic-Approaches-to-Process-Optimization-and-S/ArticleStandard/Article/detail/686225