Custom Search

Wednesday, January 12, 2011

What is PEGylation technology

PEGylation is a process conjugation or attaching polyethylin glycole (PEG) side chain to proteins or immunoglobulines PEG forms a covalent bond with aminoacids present in immunoglobuline or a protein used in treating some disease . PEGylation is done by incubating drug or therapeutic protein ,immunoglobuline with polyethylene glycole in a activated state for reaction.

Purpose of attaching a polyethylene side chain is to render a molecule less immunogenic or to reduce the antigenecity of a theraputic protein which are derived from other animal or natural resources the process alters the solubility of the immunoglobuline and availability for drug molecule for renal clearance and reabsorbtion and hinders the antigenic sites on the protein molecule which otherwise produce a sever untoward anaphylactic reactions. PEGylation renders hydrophobic drug molecule or in to hydrophilic.

Many drug molecules are metabolized in our body with the process of conjugation with other protein molecules like glucouronide so as to render its clearance, such conjugation process renders the molecule lesser toxic , the process of peglytation can be related to such naturally occurring process in human body to render a drug molecule less toxic or less immunogenic, and alter the drug distribution in our body.
PEG polymer usualy reacts with hydroxyl groups on protein or drug molecules viz aldehyde, esters, amides and anhydrides, acid chlorides, chloroformates carbonates.

Drugs so far developed with PEGylation technology are as follows.

Enzon Pharmaceuticals  Inc, US, was the first company to introduce PEGylation technology and drug
ADAGEN (PEG- bovine adenosine deaminase) was the first drug manufactured by them to get approved by US FDA in March 1990. ADAGEN is used to treat X-linked severe combined immunogenicity syndrome, as an option to enzyme replacement by gene therapy and bone marrow transplantation.

Hoffmann-La Roche
PEGASYS: PEGylated interferon alpha for treating chronic hepatitis C and hepatitis B

Schering-Plough / Enzon
Pegintron: PEGylated interferon for treating chronic hepatitis C and hepatitis B

Oncaspar: PEGylated L-asparaginase for treatmenting acute lymphoblastic leukemia for patients hypersensitive to unmodified L-asparaginase (Enzon).

Amgen
Neulasta: PEGylated recombinant methionyl human granulocyte colony-stimulating factor for treating neutropenia induced in cancer chemotherapy.

Ortho Biotech / Schering-Plough
Doxil/Caelyx: PEGylated liposome with doxorubicin for treating cancer.

Savient Pharmaceuticals Inc
Pegloticase to lower uric acid level in gout.---read more about this drug which is one of latest approved drug which manufactured by using PEGylation technology


What are bacterial toxins , endotoxin , exotoxins and anaphylactic reaction


Why Betalactam Antibiotics require a separate manufacturing aria in a pharmaceutical manufacturing company? Chemistry behind the allergic reactions and mode of action of betalactum antibiotics
=====================================================================================================
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.

1 comment:

Paresh Bharodiya said...

pegylation is indeed a good technology to improve therapeutic importance of peptide and proteins but most of the proteins and peptide pegylated so far are for only parenteral administration so significant attention must also be paid to make this technology work for oral administration of proteins..

Posted by: Martin

How to sucessfuly activate and receive our articles on pharmaceuticals by E-Mail

Dear readers if you wish to receive our articles on pharmaceutical automatically into your email Inbox , as and when we write a new article over this website, then follow these 3 simple steps.


1.You should write your Email ID in the box provided and push the subscribe butten


2.Enter the text code that we show you in a small new browser window after you enter your email ID.

3.Log in to your email and Cheke our verification email sent by "FEEDBURNER" , there you should verify the link we send you by email.




Enter your email address get our articles by email whenever this website is updated





Delivered by FeedBurner



Join the list of our readers from Universities ,Research and Development centers Pharmaceutical Companies from all over the world.











Pharma Research Regulatory Guidelines Website
Texas Dallas, TX 75211 US
Email: editor@pharmacistspharmajournal.org Website: http://pharmacistspharmajournal.org/
Copyright © 2008-2015 all rights reserve www.pharmacistspharmajournal.org