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
-Kind and size – depends on goals; evaluating product and process; producing samples of product for evaluation; market testing or furnishing to potential customers -Location: near R&D facility? At an existing plant? Close liaison between R&D and pilot plant staff is essential -Labor requirements and costs: engineering staff, skilled operations and maintenance staff- pilot plant costs may exceed those of usual plant production costs. The pilot plant may be used for training personnel for a full- scale plant
Objective of scale up --“Find mistakes on small scale and make profit on large scale.”
-To produce physically and chemically stable therapeutic dosage forms. -Review of the processing equipment. -Guidelines for productions and process control. -Evaluation and Validation. -To identify the critical features of the process. To provide master manufacturing formula.
Pilot plant studies include the close examination of the formula to determine:
-Its ability to withstand batch scale . -Process modification . -Compatibility of the equipment with the formulation. Cost factor. -Availability of raw materials meeting the specifications required to produce the product. -Market requirement. -Physical space required and the layout of the related functions
Thus , during the scale up efforts in the pilot plant: -Production and process controls are evaluated , validated and finalized. -Product reprocessing procedures are developed and validated . -Appropriate records and reports are issued to support cGMP
PILOT PLANT DESIGN A pilot plant design should support three key strategic objectives:
-Formulation and process development. -Clinical supply manufacture. -Technology evaluation , scale up and transfer.
Attributes playing a key role in achieving the above objectives are :
-cGMP Compliance. -A flexible highly trained staff . -Equipment to support multiple dosage form development . -Equipment at multiple scales based on similar operating principles to those in production . ... PILOT PLANT OPERATION Operational Aspects of Pilot Plant includes:
-Validation Training Engineering Support Maintenance Calibration -Material Control Inventory Orders Labeling Process and Manufacturing Activities -Quality Assurance and Quality Control
VALIDATION: A validation master plan should be develop that addresses--
-The design specifications Installation qualification -Operational qualification -Performance qualification of all major utility systems, process equipment, and computer control systems. -A fully validated pilot plant should ensure compliance with cGMP and should meet current FDA standards.
TRAINING: Training in four major area required–-
-Compliance with quality standards such as cGMP Safety and environmental responsibilities -Compliance with SOPs Technical skills and knowledge ... MAINTENANCE: It is required to –-
-Meet cGMP norms -To ensure data integrity and equipment reliability during the development process. -The maintenance program should be documented and written procedures established.
CALIBRATION: Calibration of critical instruments/equipments is required for–-
-Compliance with cGMP Maintaining the integrity of data generated during the development process -Calibration should be performed by well trained and expert staff ... PROCESS EVALUATION:
-It is the basis of process validation -Documentation of process is to be done. -Process is validated only if there are no changes in the formula, quality of the ingredients, or the equipment configuration -Revalidation needs to be done to ensure that changes have not take place.
GMP CONSIDERATIONS: GMP Items that should be a part of scale up are --
-Equipment qualification -Process validation -Regularly schedule preventive maintenance -Regularly process review & revalidation -Relevant written standard operating procedures -The use of competent technically qualified personel -Adequate provision for training of personel -A well-defined technology transfer systemValidated cleaning procedures. -An orderly arrangement of equipment so as to ease material flow & prevent cross-contamination http://www.academia.edu/8939649/PILOT_PLANT_SCALE_UP_TECHNIQUES_CONTENTS_INTRODUCTION_ON_PILOT_PLANT_AND_SCALE_UP
Dr. Eugene Seymour clearly stated scale-up studies was a laborious process (paraphrasing) but we are moving forward now with the commissioning of the new state of the art, multi-kilogram Pilot Plant in Shelton, CT to produce FluCide(TM), announced on January 2015.
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].
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
