What is a prion , What is Mad Cow Disease , What is Creutzfeldt–Jakob disease:
We all know about bacteria’s , viruses and fungi which causes serious infectious diseases in humans and animals , do you know about a protein molecule possessing same virulence , or activity just similar to bacteria’s and viruses .
Lets have a look at such complex protein molecule capable of producing symptoms of a virulence / infection in human or animal infected with it.
Its known as prion , are misfolded protien , it do not contain any RNA or DNA , as against other infectious microorganisms which multiply in their number using genetic information stored in to genes in DNA or RNA and to control and develop drug resistance or antibiotic resistance against incoming drugs or antibiotics a natural mechanism of their survival in an infected substrate .
Prion is capable of affecting brain and nervous tissue in human and animals, and can cause serious disease conditions like degenerative neurological disorder (brain disease) human and animals, a type of spongiform encephalopathy which is also a transmissible form, in humans it is called as Creutzfeldt–Jakob disease.
Animals infected with proin develop Bovine spongiform encephalopathy (BSE ) also known as Mad Cow Disease , In humans it is called as Creutzfeldt–Jakob disease.
Individual affected with proin develops in to Creutzfeldt–Jakob disease which result in to spongy degeneration in the brain and spinal cord .
Symptoms Creutzfeldt–Jakob disease , include rapid and progressive memory loss a state of dementia which also result in to changes in personality and individual develops hallucinations. Impaired Speech, changes in gait, rigid posture, and seizures , (myoclonus) jerky movements and (Ataxia) a state of impaired balance and coordination dysfunction.
Constituents of Proin :
Proin are made up of proteins , basically of abnormally folded PrP proteins , PrP proteins otherwise are also normal constituents of human and animal body , PrP in normal human individuals are in a state of normal folded pattern of proteins(orientation) where as PrP in a prion are in the state of abnormaly folded protein chains.
Role of PrP proteins in human body : It is belived that PrP proteins may be responsible for maintaining long term memory and may have a role in maintain a normal neurological functions, which is still to be investigated.
Mode of action of Prion :- Up on transmission in to a healthy individual Prion initiate a series of chain reactions , which result in to formation of abnormal folding in to otherwise normal PrP proteins in humans and animals body .
Transmission of proin to human is believed to be through
1.Eating food contaminated with tissues or consuming tissues of proin affected animals.
2. Through use of contaminated harvested human growth hormone (HGH) products and Immunoglobulins (IVIG)
3. Blood transfusions , as the UK was most affected with this disease a in there is ban in UK for blood donation by a individual who had received a blood transfusion since January 1980 , there is a ban for manufacturing of blood fractions like albumin in UK since 1999 by using blood of individuals from UK.
4. Heredetory : The disease becomes hereditary through a mutation in the gene for PrP , PRNP in an individual affected with disease.
In USA blood donation is prohibited for an individual who has spent three months in UK or total of five years or more of civilian travel in European countries.
Also see http://whoguideline.blogspot.com/2010/08/testing-for-adventitious-agents-cell.html
Sterilization / destruction of proin / Decontamination procedures:
Proins are resistant to heat, radiation proteases, and formalin treatments as renaturation to some extent from denatured state may occur easily. Hence a combination of chemical hydrolysis of proin protein combined with moist heat sterilization is most effective method of decontamination of.
Also see sterlity testing in sterile dosase form
1. Autoclaving by immersing in a pan containing 1N NaOH and heat in a gravity displacement autoclave at 121°C for 30 minutes further rinse and clean with water and then perform regular sterilization processes.
2. Autoclave at 121°C for 1 hour heat in a gravity displacement autoclave , or in a porous-load (134°C) autoclave for 1 hour with a prior treatment in 1N NaOH or sodium hypochlorite solution (20,000 PPM of available chlorine) for 1 hour, further rinse and clean with water and then perform regular sterilization processes.
=====================================================================================================
Do you know now this website has become a most popular and most referred website in pharmaceutical industry and in pharmaceutical companies by pharmaceutical manufacturers from all over the world for almost all topics related to FDA guildelines, GMP guidelines for Pharmaceutical Manufacturing (Current Good Manufacturing Practice for Pharmaceutical Manufacturing , c GMP guidelines ),and technical aspects of pharma manufacturing research and development , Pharma Regulatory Affairs and latest news and new drugs developments.
=====================================================================================================
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http://whoguideline.blogspot.com/2010/04/terminalogy-and-their-explanations.html
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http://whoguideline.blogspot.com/2010/02/pharmaceutical-aseptic-manufacturing.html
Here are some articles which will be useful for you in further understanding of aspects of sterile dosage form manufacturing and regulatory affairs and good manufacturing practice in
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Pharmaceutical Validation
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Requirements of documents for validation of sterilisation process
How to investigate OOS out of specification results
Determination of Phenol coefficient of a disinfectant
Sterility testing
Clean Room Classification
Time limitations in sterile pharmaceuticals processing
Aspects of validation of manufacturing process in sterile pharmaceuticals
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Find a Job in Pharmaceutical Company -->JOBS IN PHARMA INDUSTRY<---
To Find Pharmaceutical jobs and make a Pharmaceutical careers see here pharmaceutical companies
Here are some interesting articles on Quality assurance systems for pharmaceutical company
Quality assurance in pharma industry
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Quality by design concept in pharmaceutical industryan explanation
Useful Books For Pharmaceutical Manufacturers and Pharmaceutical Professionals
What is Therapeutic Index ?
What is Narrow Therapeutic Range Drug?
What is What is a High-Efficiency Particulate Air (HEPA) filter ?
What is 21 CFR Part 11, US FDA compliance and CFR 21 Part 11.
We all know about bacteria’s , viruses and fungi which causes serious infectious diseases in humans and animals , do you know about a protein molecule possessing same virulence , or activity just similar to bacteria’s and viruses .
Lets have a look at such complex protein molecule capable of producing symptoms of a virulence / infection in human or animal infected with it.
Its known as prion , are misfolded protien , it do not contain any RNA or DNA , as against other infectious microorganisms which multiply in their number using genetic information stored in to genes in DNA or RNA and to control and develop drug resistance or antibiotic resistance against incoming drugs or antibiotics a natural mechanism of their survival in an infected substrate .
Prion is capable of affecting brain and nervous tissue in human and animals, and can cause serious disease conditions like degenerative neurological disorder (brain disease) human and animals, a type of spongiform encephalopathy which is also a transmissible form, in humans it is called as Creutzfeldt–Jakob disease.
Animals infected with proin develop Bovine spongiform encephalopathy (BSE ) also known as Mad Cow Disease , In humans it is called as Creutzfeldt–Jakob disease.
Individual affected with proin develops in to Creutzfeldt–Jakob disease which result in to spongy degeneration in the brain and spinal cord .
Symptoms Creutzfeldt–Jakob disease , include rapid and progressive memory loss a state of dementia which also result in to changes in personality and individual develops hallucinations. Impaired Speech, changes in gait, rigid posture, and seizures , (myoclonus) jerky movements and (Ataxia) a state of impaired balance and coordination dysfunction.
Constituents of Proin :
Proin are made up of proteins , basically of abnormally folded PrP proteins , PrP proteins otherwise are also normal constituents of human and animal body , PrP in normal human individuals are in a state of normal folded pattern of proteins(orientation) where as PrP in a prion are in the state of abnormaly folded protein chains.
Role of PrP proteins in human body : It is belived that PrP proteins may be responsible for maintaining long term memory and may have a role in maintain a normal neurological functions, which is still to be investigated.
Mode of action of Prion :- Up on transmission in to a healthy individual Prion initiate a series of chain reactions , which result in to formation of abnormal folding in to otherwise normal PrP proteins in humans and animals body .
Transmission of proin to human is believed to be through
1.Eating food contaminated with tissues or consuming tissues of proin affected animals.
2. Through use of contaminated harvested human growth hormone (HGH) products and Immunoglobulins (IVIG)
3. Blood transfusions , as the UK was most affected with this disease a in there is ban in UK for blood donation by a individual who had received a blood transfusion since January 1980 , there is a ban for manufacturing of blood fractions like albumin in UK since 1999 by using blood of individuals from UK.
4. Heredetory : The disease becomes hereditary through a mutation in the gene for PrP , PRNP in an individual affected with disease.
In USA blood donation is prohibited for an individual who has spent three months in UK or total of five years or more of civilian travel in European countries.
Also see http://whoguideline.blogspot.com/2010/08/testing-for-adventitious-agents-cell.html
Sterilization / destruction of proin / Decontamination procedures:
Proins are resistant to heat, radiation proteases, and formalin treatments as renaturation to some extent from denatured state may occur easily. Hence a combination of chemical hydrolysis of proin protein combined with moist heat sterilization is most effective method of decontamination of.
Also see sterlity testing in sterile dosase form
1. Autoclaving by immersing in a pan containing 1N NaOH and heat in a gravity displacement autoclave at 121°C for 30 minutes further rinse and clean with water and then perform regular sterilization processes.
2. Autoclave at 121°C for 1 hour heat in a gravity displacement autoclave , or in a porous-load (134°C) autoclave for 1 hour with a prior treatment in 1N NaOH or sodium hypochlorite solution (20,000 PPM of available chlorine) for 1 hour, further rinse and clean with water and then perform regular sterilization processes.
=====================================================================================================
Do you know now this website has become a most popular and most referred website in pharmaceutical industry and in pharmaceutical companies by pharmaceutical manufacturers from all over the world for almost all topics related to FDA guildelines, GMP guidelines for Pharmaceutical Manufacturing (Current Good Manufacturing Practice for Pharmaceutical Manufacturing , c GMP guidelines ),and technical aspects of pharma manufacturing research and development , Pharma Regulatory Affairs and latest news and new drugs developments.
=====================================================================================================
You may also like following articles
What is Therapeutic Index ?
What is Narrow Therapeutic Range Drug?
What is High Efficiency Particulate Air( HEPA ) filter ?
What is a Laminar Air Flow Cabinet.
What is an Isolator in pharmaceutical manufacturing.?
What is 21 CFR Part 11, US FDA compliance and CFR 21 Part 11?
CFR 21 part 11 and its application on computarised systems used in clinical trials US FDA guidelines
What is High-Efficiency Particulate Air HEPA Filter
What is 21 CFR Part 11, US FDA guidelines requirements of FDA compliance and CFR 21 Part 11.
What is a Site Master file of a pharmaceutical company
What is Generic Drug
What is Reference Listed Drug ? ( RLD )
What is Pharmaceutical Equivalents
What is Pharmaceutical Alternatives
What is Therapeutic Equivalents
What are Post Market studies
Why a drug is bound to protein, What is protein binding? What is drug absorption , distribution ?
Do Physical properties contribute to drug activity.
What is drug receptor , How a drug resistance occurs
Mechanism of drug resistance
What is drug interaction
Drug interaction, and its examples
What is first pass metabolism of a drug
What is What is 510(k) Clearances ?
What is 510(k) Clearances,
Premarket Notification for medical devices - PMN or 510(k)
What is a drug interaction
Examples of drug interactions
Antibiotic Definition and classification
Antibiotic Resistance and Antibiotic resistance mechanism
Antioxidants food supplements
Vitamin D Details on FDA cautions on accurate dosage of Vitamin D
What is an antibody? what is monoclonal and polyclonal antibodies?
Terminologies In vaccine Production
Multi stage testing of Virus vaccine production
Testing of vaccines at different stages of production
TESTING FOR ADVENTITIOUS AGENTS CELL PROPERTIES IN VIRAL VACCINE PRODUCTION
Enzyme linked immunosorbent assay ELISA
Raido Immuno assay
http://whoguideline.blogspot.com/2010/04/terminalogy-and-their-explanations.html
Pharmaceutical Aseptic Manufacturing Process Terms , Terminology and Definitions.
http://whoguideline.blogspot.com/2010/02/pharmaceutical-aseptic-manufacturing.html
Here are some articles which will be useful for you in further understanding of aspects of sterile dosage form manufacturing and regulatory affairs and good manufacturing practice in
pharmaceutical industry
Pharmaceutical Validation
Types of validations in pharmaceutical manufacturing
Requirements of documents for validation of sterilisation process
How to investigate OOS out of specification results
Determination of Phenol coefficient of a disinfectant
Sterility testing
Clean Room Classification
Time limitations in sterile pharmaceuticals processing
Aspects of validation of manufacturing process in sterile pharmaceuticals
Clinical Trials
Requirements of US FDA Inspections of Clinical Investigators of Clinical Trials
PROCEDURE OF AN INSPECTIONS OF CLINICAL TRIAL INVESTIGATOR BY US FDA HOW ARE CLINICAL INVESTIGATOR INSPECTIONS CONDUCTED?
US FDA INSPECTION OF CLINICAL INVESTIGATORS OUT OF UNITED STATES OF AMERICA
REPORTS AFTER AN INSPECTION OF A INVESTIGAOTR OF CLINICAL TRIALS
Controlling Pyrogens in injectable dosage forms
Media fill run process simulation aspects Validation of Aseptic Process and Sterilisation
Injectable Dosage Form Asepict Techniques Sterile dosage form manufacturing imprtant aseptic techniques
New Drug Application (NDA) how to make a New Drug Application (NDA) to US FDA
Abbreviated New Drug Application (ANDA) What is ANDA , detailed information about ANDA preparation and submission to US FDA
How to make Investigational New Drug (IND) Application to US FDA
Drug applications submission to us fda Over the counter Drugs OTC drugs
BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS
Electronic record in pharmaceutical manufacturing industry
Good manufacturing practice in pharmaceutical industry
Pharmaceutical industry pharmaceutical companies and FDA latest updates
Here is an interesting article on world wide pharmaceutical industry and making a carrier in one of pharmaceutical companies article on Pharmaceutical Industry pharmaceutical industry
Find a Job in Pharmaceutical Company -->JOBS IN PHARMA INDUSTRY<---
To Find Pharmaceutical jobs and make a Pharmaceutical careers see here pharmaceutical companies
Here are some interesting articles on Quality assurance systems for pharmaceutical company
Quality assurance in pharma industry
Quality by design concept for pharmaceutical industry
Quality by design concept in pharmaceutical industryan explanation
Useful Books For Pharmaceutical Manufacturers and Pharmaceutical Professionals
What is Therapeutic Index ?
What is Narrow Therapeutic Range Drug?
What is What is a High-Efficiency Particulate Air (HEPA) filter ?
What is 21 CFR Part 11, US FDA compliance and CFR 21 Part 11.
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