Jan. 7, 2015...All of the infrastructure systems needed for production of the nanoviricides® drug candidates are now operational at the new facility, and have either been validated by outside experts, or are in the process of such validation.
April 27, 2015...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
Commissioning and validation of a new pharmaceutical facility should be considered the optimal goal, as the ROI is not realized until the facility can make product. Budgets and timelines usually become the target focus through a majority of traditional construction projects, sometimes leaving the commissioning and validation of the facility as the final area of focus [3].
The following should be ingrained in everyone's mind:
1) NanoViricides, Inc. commissioned the new state-of-the-art multi-kilogram Pilot Plant in Shelton, CT, to produce FluCide(TM)/GLP, sometime in early Jan 2015 2) On Mar 31, 2015 - We are now progressing to a 1kg scale-up of FluCide, and enabling in-process control instrumentation--- CMC studies to enable further scale-up from the current multi-100g scale of production to kg-scale production. 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.
-We are now making the FluCide(TM) material for Phase III in large animals!
June 1, 2015, 9:47 PM
FluCide
Phase I and II of tox successfully completed
Making material for last Phase in large animals . . . Had FluCide not turned out to be so incredibly safe, we would have been done with tox by now. Incredibly safe is not a bad thing at all!
Eugene Seymour MD MPH Chief Executive Officer NanoViricides, Inc eugene@nanoviricides.com www.nanoviricides.com 310-486-5677 "NNVC" on the New York Stock Exchange
The c-GLP Tox Package study will be conducted by BAS incorporated (BASi), a well-known contract laboratory excelling in such studies. As we institute this study, we plan to use the same material for additional efficacy studies of our drug candidate against a number of different influenza virus types, subtypes, and strains. This is required to ascertain the broad-spectrum nature of the drug candidate. Our earlier studies have already demonstrated that this drug candidate is highly effective against both Type I and Type II Influenza A viruses in highly lethal animals studies. We believe that it should be capable of attacking almost any Influenza A virus, because it mimics the sialic acid receptor that all influenza viruses use to enter a host cell. After these studies are complete, and we have the reports in hand, we will be able to submit an "Investigational New Drug" application (IND) to the US FDA. An IND also requires at least two consistent cGMP batches of the drug to have been produced. However, certain international regulatory agencies do not require cGMP product, but rather cGMP-like product. The difference is subtle, but can make a difference of several months. We plan on taking advantage of this and try to request permission for human clinical trials abroad soon after we can make cGMP-compliant product in the new facility. The number of patients that need to be enrolled in a clinical trial depends upon how good the drug is. If the drug effect is very easily separated from the placebo, and more so, from the standard of care, then the trial would require fewer patients to reach the clinical end point of determining that the drug is indeed effective or superior, as the case may be. Therefore we believe, based on the very strong efficacy observed in our animal studies, that our influenza clinical trials will be short, and will be relatively inexpensive.
http://www.nanoviricides.com/2014-ceo-letter.pdf
The difference is subtle...
Deviations and Change Control. A system of change control is important during product development - not to force a rigid system of documentation, but simply to record the changes that will, by necessity, take place as the production process is refined. For example, with biological products, even small changes sometimes have major repercussions and can change the quality of the finished product. What happens if after manufacturing five consecutive pre-clinical batches using the same process, the researcher discovers that the next batch is "different"? All further development may stall until the "which" hunt - to locate which variable(s) caused the aberrant batch - is satisfactorily concluded. When these circumstances arise, the accuracy and reliability of manufacturing documentation will be instrumental to quickly identifying critical process parameters.
Not surprisingly, the most common (and often, most serious) problems usually occur due to lack of detailed documentation of "minor" process changes. In fact, it is relatively rare for firms to be able to accurately trace the development of a product from initial research through commercial scale-up. Inevitably, there are gaps; most often, at the early research stage or at the technology transfer stage. These lapses can be particularly costly if the manufacturer discovers a problem with the scaled-up product, then finds that the manufacturing method used at commercial scale neglected to include several unrecorded "process improvements" developed at the bench or pilot scale. Such events are not uncommon, and if atypical product is used in toxicological or clinical trials, years and hundreds of thousands of dollars can be lost.
Therefore, it is important during product development to utilize some type of systematic investigation process for unexpected results, and ensure that the findings from these investigations are incorporated into the development plan. Relatedly, a process for recording changes in methods and procedures as they occur is also needed.
Facilities and Equipment. Although it generally is not necessary to fully qualify all equipment and validate all processes used in the manufacture of a product during its early development stages, it is important to document which equipment was utilized, why it was selected, and how it was used, cleaned, etc. If calibration of the equipment used to manufacture the product would typically be required in a GMP environment, a similar system is highly desirable at the research and development stage. In short, an intelligent evaluation of which pieces of equipment are critical to the operation should be made as soon as possible, and those critical pieces of equipment should be targeted to achieve compliance with "GMP-like" requirements by the time clinical-grade material is produced. Analogously, if the manufacturing process requires microbiologically-controlled facilities, it is prudent to measure and document the environmental control of these facilities to maintain product integrity and comparability.
Setting priorities for reaching compliance with GMP requirements is an integral part of product development planning. Once critical facilities and equipment have been identified, it is time to establish a schedule for generating compliance documentation. During product development, the move toward full compliance with Good Practice regulations is best regarded as a continuum, rather than a "now nothing, now everything" approach.
http://www.regulatory.com/forum/article/gdps.html
Who do you believe, a "Tokyo Rose"-like anonymous poster with many aliases, posting from somewhere in Washington, D.C., New York City - Wall Street, California/Big Pharma office, the Kremlin - Russia, Beijing - China, all trying to scare "longs" out of their wits by using their financial might to drive the nav of NNVC shares to a new low?...or do you believe Dr. Milton Boniuk, an independent director/insider who is buying with great frequency and confidence?
NanoViricides Appoints Baylor Professor Dr. Milton Boniuk as an Independent Board Member
WEST HAVEN, CONNECTICUT -- May 21, 2013 -- NanoViricides, Inc. (OTC BB: NNVC) (the "Company") announced today that it has appointed Milton Boniuk, MD, the Caroline F. Elles Chair Professor of Ophthalmology at Baylor College of Medicine, as an independent member of the Company’s Board of Directors.
Dr. Boniuk is an astute and highly successful businessman and entrepreneur, in addition to being an accomplished eye surgeon, educator, and administrator. Currently, he is the Caroline F. Elles Chair Professor of Ophthalmology in the Alkek Eye Center at the Baylor College of Medicine, Houston, TX. He conducts a busy clinical practice in orbital surgery, eyelid reconstruction, ocular oncology and comprehensive ophthalmology. Additionally, he plays a major role in Baylor’s resident and fellow medical doctor education programs.
Dr. Boniuk has been a long term investor and strong supporter of NanoViricides, Inc.
“Milton’s strong business acumen, integrity, and professional expertise will be of great help in strengthening our corporate governance as well as fostering our drug development activities,” said Eugene Seymour, MD, MPH, CEO of the Company.
Dr. Boniuk has made significant contributions in cataract surgery, glaucoma, corneal dystrophies, retinal diseases and surgery. He is a nationally and internationally recognized expert in the pathology and surgical management of orbital and intra-ocular tumors. His description of the ocular pathology of the congenital rubella syndrome in 1967 was a landmark publication. Of note, Dr. Boniuk has made substantial medical contributions in areas that are of great significance to the Company, such as ocular adenoviral infections, that cause epidemic kerato-conjunctivitis (EKC). The Company has developed a drug candidate for EKC infection that was successfully tested in rabbits. These animals serve as a surrogate for the viral disease in human eyes.
“Dr. Boniuk brings a unique set of skills to the Board of NanoViricides, Inc.,” said Anil R. Diwan, PhD, President of the Company, adding, “He shares our enthusiasm for the novel biomimetic nanoviricides® technologies and the resulting anti-viral drugs. In addition to strengthening our corporate governance, he will be of great value in progressing our drug development programs into the clinic.”
Dr. Boniuk is also well known for his philanthropic endeavors. He and his wife Laurie founded the National Society for Parent and Child Development in 1989. In 1994, he established the Lions Eye Bank Foundation’s Milton Boniuk, M.D., Endowment Fund to support resident research in the Ophthalmology Department at Baylor. In 2004, Milton and Laurie Boniuk contributed $5 million to Rice University to establish the Boniuk Center for the Study and Advancement of Religious Tolerance. In 2013, they gave an additional $28.5M to Rice University to upgrade this Center to The Boniuk Institute for the Study and Advancement of Religious Tolerance. The Boniuk Institute will conduct research, public outreach and educational programming. Its mission is to foster multidisciplinary research that leads to innovative ways to understand and achieve religious tolerance.
Dr. Boniuk earned his MD at the Dalhousie University, Halifax, Nova Scotia, Canada, followed by an internship at the Victoria General Hospital, Halifax, Nova Scotia, Canada, and Residency at the Center for Ophthalmology, Jefferson Medical College - Wills Eye Hospital, Philadelphia, PA. In addition, he served a Fellowship in Ophthalmic Pathology at the world-renowned Armed Forces Institute of Pathology, Washington, DC. . . .
"There are many reasons an insider will sell a stock, but only one reason why insiders buy: They think the stock is undervalued and will eventually go up." ~ Peter Lynch
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About InstantGMP-Lite EBR demo - Electronic Batch Records for cGMP Manufacturing
