Genotoxic Impurities and our immune systems 

Dr.Sherajuli Shelley: Genotoxic impurities (GTIs) belong to a class of compounds that interact with DNA and induce genetic mutations. These compounds add significant risk without adding any benefit to patients and are also known as mutagenic impurities. Therefore, exposure to even low levels of such impurities may be of significant toxicological concern.

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Microbial Enumeration Testing (MET) Or Microbial Limits Testing It is a necessary requirement by regulatory agencies for any product that is utilized by humans or animals to ensure safety. MET is performed on a variety of pharmaceutical ingredients, medical devices, and non-sterile packaging from raw materials to the finished form of the product in order to determine the microbial load. Analysis is performed by our experts according to the strict guidelines and procedures outlined in USP<61> and USP<62>. USP<61>analysis quantifies the total aerobic microbial count and total yeast and mold count in a product being tested, while USP<62> allows for the detection of potential pathogens within a sample. Accuon Labs is capable to perform microbial limit testing as per USP <2021> and <2022>.


Water Testing
We perform microbial quantitation of all types of water for our clients to ensure that proper control is maintained throughout the manufacturing process. Quantification of microbial, mold, and yeast counts, endotoxin testing, total organic carbon, and heavy metal testing are included in the menu of options our experts offer to analyze water. All testing is completed following the strict processes outlined within the cGMP and FDA. Accuon Labs is ready to perform testing for Burkholderia cepacea complex as per USP <60>.
Antimicrobial Effectiveness Testing (AET):It is utilized to determine the effectiveness of preservatives added to nonsterile dosages of drugs. These preservatives aid in preventing microbes that may inadvertently be introduced through the process of production or repeated consumer utilization. The AET is also useful in determining whether the product’s preservative will maintain effectiveness throughout the shelf life or until expiration.


Completing the test requires inoculation of the product with a known quantity of various microorganisms. Effectiveness of the preservative is measured at varying times over the course of the next 28 days by comparing the known quantity of microorganisms introduced to the recorded quantities over the course of the testing period. We provide analysis for injections housed in multi-dose packaging, and for samples containing antimicrobial preservatives. Our scientists complete all analysis according to the processes and guidelines outlined within USP <51>, to ensure that all regulatory requirements are met for your product.


Environmental Monitoring
Environmental monitoring ensures the effectiveness of your cleaning and disinfecting processes and procedures. We are able to analyze the quality of air and surfaces within your manufacturing facility clean rooms and controlled environments following the guidelines set forth within USP<1116>. Our scientists can ensure that microbial levels will be controlled within the manufacturing environment allowing for confidence in the manufacturing of your product and reducing risk.


Following a comprehensive analyses, our experts will work closely with you in implementing an environmental monitoring program in order to keep your facility operating under the guidelines outlined under USP<1116>. We can provide you with a monitoring program that is all encompassing, ranging from, air, surface, and water quality, personnel training, and cleaning processes.

Antibiotic Potency Assays
To verify the concentration of the active pharmaceutical ingredients (API) to determine the effectiveness of the product to inhibit growth of microorganisms. FDA regulations require that potency testing be performed on all products prior to release and that the potency specifications on the product label conform to the actual potency of the product. We perform all potency assays according to the processes set forth in USP<81> following cGMP standards. Methodologies we use in determining antibiotic potency include the cylinder plate and the turbidimetric assays. Strict controls are employed in both methods ensuring our clients they will receive the most precise and accurate reports following analysis.


Enumeration Of Probiotics
Enumeration of probiotics is vital for manufacturers in gathering data to support the potency and purity of their products. Consumers purchasing products in the booming health and wellness industry are savvy buyers, and want the most accurate labeling information. Probiotic organisms must be living and available in sufficient numbers in order to have health benefits. We utilize specific culture methods enabling us to target your probiotic organism and assist you in quantitating the colony forming units (CFUs) within your product. Our analysis gives you the necessary information for proper labeling, allowing you to pass this critical information on to consumers.Quick

Still today at present our laboratory is the key to this prevention of quality deterioration of raw materials fruits and vegetables at the national and international levees with coordinated effort of other pharmaceuticals scientist and food microbiology as a potential noncarsanogenic or prevention of chilling injur / physiological disorders and quality deterioration or microbiological contaminations.


Physical treatments have been shown to reduce quality deteration and prevention of chilling injury and preservation of raw materials as well as fruits and vegetables and vegetable raw materials. So far heat treatment has developed / synthesized group of protein which has ability to prevent such kind of physiological disorders and reduce quality detoriation there has been speculation among the scientific community that heat shock treatments may synthesis a special group of protein which can prevent quality deterioration. Of pharmaceuticals raw material
This research and work involves many complex steps, each of which requires sophisticated approaches and techniques that will be developed depending on the caliber of the scientists involved. I have worked on the prevention of chilling and quality deterioration of products or fruits and vegetables and pharmaceuticals specially they are made of animal and plant sources for 35 years and my sills have become indispensible to the industry or team that is working on improving the health of the American people I served America and American people more than 18 years and work other countries United Nation university Tokyo for the interest of science and humanity by providing nutritious and super quality medicals products and served American people and keep the quality up. The interruption of the ongoing research projects wills seriously the program, protocol test ion, method SOP in the prevention of chilling injury and pathogens.

There are grounds for cautious optimism that we may now be near the end of the search for the ultimate laws.(Stephen W. Hawking .1988)
The area of research holds a great potential for the advancement of health services which is only possible with the present technologies in plant physiologogical and genetics. Many postharvest physiological and numerous scientists in health and nutrient research have suggested that people could reduce the risk of many diseases through modifying their dietary habits such consumption of the super food or super pharmaceuticals products. Ours is the only consortium in the US consisting of scientists working in the areas fruits raw materials for pharmaceuticals finished products and vegetable genetics chemistry food processing pharmaceutical s product processing and microbiology, related to nutrition and health and our team is organized to initiate studies, specifically on the nonchemical preservative less treatments for finished products which is effective in fruits and vegetables and products .

Anatomy is to physiology, as geography to history; it describes the theatre of events.
(Jean Fernel, 1542)
These studies will determine the effects of certain physical treatments on prevention of specific diseases and disorder , and prevention of fruits and vegetables and raw materials for pharmaceuticals uses which is superior for human consumption and good for health.

POTENTIAL FOR IMPROVING THE ECONOMY.
In the previous sections , I mentioned that pharmaceuticals raw materials fruits and vegetables that were pretreated with nonchemical non preservative , I,e physical treatment have good quality , free from toxic chemicals residue have a impact on the health of the people. The cost treating the diseases increased annually at a rate greater than the inflation. The cost treating the disease increased annually at a rate greater than the inflation. The cost of physical treatment i.e. nonchemical treatment for food preservation is considerably less than the actual health care costs incurred by any fraction of that population that develop disease.
The USA government pay annually a lot of money to preserve fresh fruits and vegetables and pharmaceuticals raw materials by chemical means, but the food and raw materials still have contain chemical residue which is harmful for USA people and loss of lot of money and FDA does not want that manufacturer use by chemicals means which is contain toxin
Nonchemical treated food or raw materials can save a lot of USA dollars as well people health will improve by consuming nutrients ingredients medicals products and problems and foods. thus, the health care costs can be substantially reduced while avoiding several million American health. Therefore no mechanical food or raw materials preservation could become a major initiative to study assess and develop designer , food raw materials which are free from chemical residue and rich in most essential nutrient Clements for human .moreover I said earlier actually raw material contribute economic welfare of the country or company those who are in production

The market potential for such designer food or product will be considerable in the next 25 years as Americans increase their awareness of proper diets and medicines.
A good example that there are many of fruits and vegetables and raw material for pharmaceuticals products variety which was only due to some variety of fruits and vegetables and products materials. However if we consider the total fruits and vegetables and pharmaceuticals industry in USA , there is tremendous potential for improving the American economy.
My expertise in developing designer foods medicines is essential and a reduction of diseases ,pathogens incidence of our people just 10% would results in considerable saving to the American economy. Without this type of research. We would be forced to rely on synthetic chemicals and more soctly for prevention of diseases or disorders and preservation of fruits and vegetables and pharmaceuticals products and also human.
Genes makes protein, and proteins make money.(microbiologist and biotechnologist (2021).

DR.S.I.SHELLEY IN FORMER USS R ACADEMY OF SCIENCES IN 1984 MOSCOW


THIS IS THE FAMOUS BIKROMPUR BHUYIAN SHINEPUKUR NOWABGAONG AND BIKROMPUR VAOUR LOHOJONG.IN COVID -19 THROUGH LOT OF DIFFICULTIES HELPED BOST POOR PEOPLE AND ADVICES THEM AS PER DR. S.I.SHELLEY’S ASEPTIC TECHNIQQUE AND INEXPENSIVE REALISTIC AND PRAGMATIC PROCEDURES .WE ARE PRUD OF THIS BHUIYAN FAMILY .NOW LIVING IN BONOSIRI DHAKA BANGLADESH.
SEEN HERE IN THE PICTURE LEFT MR.ABIR BHUIYA ENGINEERING STUDENT DHAKA ENGINEERING UNIVERSITY.
MR. AYON BHUIYAN MEDICAL SCIENCES BANGLADESH, MOTHER MRS SHEIKH AFROSA AKTHAR BHUIYAN. BHIND HEAD OF THE BHUIYAN FAMILY MR. MUHAMMAD ANWARUL ISLAM BHUIYAN NOCK NAME SHENTU BHUIYAN IS A PRIVATE BUSSINESS MAN , MISS .SYNTHEYA BHUIYAN COMMERCE COLEGE STUDENTS AND MR. ARNOB BHUYIAN .SCHOOL STUDENT . THEY ARE PURE MUSLIM FAMILY FOLLOWING QURAN AND HADIZT .THOGH COVID -19 AFFECT THEIR ECONOMIC SOCIAL LIFE BUT IN THE NAME OF ALLAH AND RASUL THEY ARE FINE AND ALWAYS SUKRANA TO ALLAH.

Currently , I am involved in research which has different part .as a microbiologist ,biotechnologist and doctor of biological sciences in including agronomy such agricultural sciences working on biological nitrogen fixation and consulting researching in USA , my work is being carried out at the Bangladesh research council and Bangladesh jute research institute and research council and my suggestion was involved in different hospitals special for diseases control and prevention virus .coronovirus and quality medical pharmaceuticals Products and medicals products and problems and working winder labs . Georgia.
I
The first part of our research project is to develop techniques to reduce /prevent chilling injury of fruits and vegetables and pharmaceuticals raw materials and also reduce the quality deterioration during storage, handling or shipment. our studies have related to fruits and vegetables and pharmaceuticals raw materials and finished products stability that can be preserve without danger of chilling injury and it can be maintain their quality properly. This gives fruits and vegetables or products a unique niche in the global market. This fruits and vegetables and raw materials have good quality and has made it a favorite among the consumers and it has become a branded product.
II.
The second part of our research involves the introduction of fruits and vegetables and raw materials to the market inside and outside .much of the loss was due to the sub-optimal shipping, or the post handling conditions in different places. The high temperature and humidity spores to germinate and the infect the fruits and vegetables. With our effort, we have developed a unique technique which eliminates major losses due to these problems consistently. Significant progress, achieved by transits simulation and post –transit trails. Can saved 40% loses of exported fruits and vegetables to foreign country and or any other country to country of the world has increased about two fold since long time , we are the pioneer of this techniques which has great potential for the food industry and pharmaceuticals industry .these research results will allow American growers or any countries growers to build confidence in exporting their product to Japanese market or any market that has been difficult to enter, the European common market , Mexico and Canada. The goal of our research to guarantee a continuing increase in the number of jobs and healthier balance of trade for USA . in addition ,our project has placed particular emphasis on research and development and made it a cornerstone for its success in commercialization which can lead to creation of more jobs in the USA.
In addition to benefiting the United States in terms of health condition/ care the advanced techniques worked out during my research will allow the United States fruits and vegetables and pharmaceuticals raw material. Raw material which is brings economic welfare to the country oand industry owner to complete more effectively against the foreign industries.

We are learning the language with which God crated life.
(U.S .President Bill Clinton, April .2000)

IV. SUMMARY
I am a professional research scientist having more than 35 years experience in the different countries of the world studied Timiryazev agricultural academy OF Moscow USSR Academy of sciences and Patrice Lumumba university studded biological sciences and agronomy sciences agricultural sciences has great knowledge in different field of sciences and am selected Member of royal society of biology MRSB and sleeted candidate Fellowship royal society FRSB.and always worked with a team of outstanding scientist to identify the best techniques to preserve fruits and vegetables and raw materials for different industrial process materials and maintain their better quality by nonchemical treatments .toxin free treatments . this is unique group, whose goal is to provide the USA people super quality products which is better for good health and for hope of better healthy life of the American people, because of my unique skill in complex techniques and dedicated efforts over the 18 years in services, I have helped to identify the best methods to prevent products diseases and identify pathogens, disorders and preserve their quality and to determine their quality nondestructively. Over the next several years using nondestructive quality measurements techniques, we will be able to evaluate products quality very quckly which is labor and time intensive as well as inexpensive.

We try to foget that medicine is for the people. It is not for the profits, the profits follow and if we have remembered that, theyhave never faled to appear(George W. Merck , 1950)
We will have significant demand for export of products to different countries and the European countries. This may help to reduce the trade deficit with respective countries. In addition to preserve materials quality and public health and economic factor, my contribution directly creates technical jobs, helps private sector for products companies to develop good cultivar, protect environmental pollution by avoiding synthetic chemicals and using natural resources.
In conclusion, I like to say biotechnology will change our lives in fundamental and beneficial ways. There will be new cures for diseases, super-accurate clinical tests and more benign, less –invasive treatments. But drug development is a business like no other. from research to financing ,investor modes from other sectors just don’t apply .you have to understand the human body and how it works in order to understand diseases pathogen or corona virus and you need to understand diseases to realize the potential of therapeutic drugs .the secret is this that corona virus is going to open our best investment to biotechnology but a fundamental problem is that people do not understand exactlywhat these companies do by name biotechnology .or what their business modes are for the long term.and first . many in wall street –a community in which quality is not prized will sell investorsanything they will buy.
Plant is our life.if you have a great idea, olid science and earthshaking discoveries ,you are still only 10% percent of the way there.

Author: Dr.Sherajuli Shelley, Assistant Manager) D. MRSB. Candidate: Fellow of Royal Society Biology of the United Kingdom. Bactolac Pharmaceutical Accuon Labs Inc , NY. USA winder labs Winder labs.
email: drsishelley1@gmail.com

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