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Thursday, April 8, 2010

Transgenic animals and biotechnology applications in pharmaceutical manufacturing

Transgenic animals are the animals whose genetic material(DNA) is modified with recombinant DNA technology where a gene which is responsible for production of hormones or proteins in human is inserted in to animal DNA , so that these animal in their normal metabolic activity produces human proteins and hormones , these human proteins and hormones can be isolated and used to treat diseases and symptoms in humans.

Recombinant DNA technology is now successfully used to create transgenic animals which are able to produce pharmaceutical products for use in humans. For Example , pigs which can produce human hemoglobin are created ,but blood obtained from such pigs can not be used directly for transfusion in humans, rather hemoglobin can be purified and used to manufacture a blood substitute , and hemoglobin injections.

Use of biotechnology in pharmaceutical manufacturing

In today’s days biotechnology is widely used in pharmaceutical manufacturing. One of the mile stone in use of biotechnology in pharmaceutical was synthesis of human insulin molecule from e.coli. bacteria
In earlier days insulin was extracted from bovine and pig’s pancreas, this animal origin insulin may become antigenic and human body is susceptible to develop resistance to such animal origin insulin, that means the dose which was effective initially may shoot up in prolonged use, similarly, the blood sugar lowering chemotherapeutic drugs too are susceptible trigger and elevate liver enzyme system which result in to faster degradation or enhances the metabolic degradation of chemotherapeutic drugs. in prolonged use .

Biotechnology revolutionized the diabetic care pharmaceuticals which eneabld us to get a exact copy of human insulin with the use of recombinant DNA technology which modified Escherichia coli bacteria to produce human insulin, A artificial gene which is responsible for coding insulin molecule in human was synthesized and inserted in to bacterial plasmid this recombinant plasmids were inserted into Escherichia coli bacteria, and normal growth process of these bacteria’s is very fast than the human tissue cells , so when ever these bacteria multiply or undergo regular metabolism , human insulin molecules are produced , and they can be purified to higher degree so that they are free from other extraneous proteins , which eliminates the chances of any antigenicity
Other application of Biotechnology is in the production of growth hormons
Natural resource for growth hormon is animal pitutory glands , which linits the availability and specificty as discuseed above.escherichia coli, bacteria is used now to produce human growth hormons

Following are some of articles which will be useful for you in further understanding of aspects of sterile dosage form manufacturing and regulatory affairs 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 coeeficient of a disinfectant

Sterility testing

Cleen Room Classification

Time limitations in sterile pharmaceuticals processing

Aspects of validation of manufacturing process in sterile pharmaceuticals

Clinical Trials

Controling Pyrogens in injectable dosage forms

Media fill run process simulation aspects Validation of Aseptic Process and Sterilisation

New Drug Application (NDA) how to make a New Drug Application (NDA) to US FDA

Abbreviated New Drug Application (ANDA) What is ANDA , detaied 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

Eletronic record in pharmaceutical manufacturing industry

Good manufacturing practice in pharmaceutical industry

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