production of biotech product

1. Presentation on:
Pharmaceutical production of biotech product.
Md. Mizanur Rahman
ID : 130101065

2. What is biotechnology:
Biotechnology is the application of biological
organisms systems or process to manufacturing and service industries
( British biotechnologists).
List of biotechnology products:
According to the Biotechnology Industry Organization, there are more
than 250 biotechnology products available,
including medicines, vaccines, fertilizers, pest-resistant crops, bio-fuels
and bio-defense products etc.
Biotechnology is being used to develop new products and technology to
fight diseases, reduce pollution, improve agriculture and manufacture
products while creating less pollution and waste.

3. Concept of Recombinant DNA :
Recombinant DNA is a molecule that combines DNA from two sources . Also
known as gene cloning. Creates a new combination of genetic material.
Recombinant DNA technology is one of the recent advances in
biotechnology, which was developed by two scientists named Boyer and
Cohen in 1973.
Received Noble prize in 1986 for his work on discoveries of growth factors
Producing Recombinant DNA molecules:
1. Isolate the gene.
2. Insert it in a host using a vector .
3. Produce as many copies of the host as possible.
4. Separate and purify the product of the gene.

4. 1. Identifying and isolating human insulin gene (cDNA, synthetic DNA )
2. cDNA insulin genes cut with restriction enzymes (restriction
endonucleases)
3. Gene transferred to a bacterial plasmid
4. Plasmid containing the human insulin gene are then transferred to the
bacterial cells (transformation)
5. Transformed bacteria are then cloned
6. Screening and Purification.
Insulin :
Human gene for insulin was placed in bacteria. The bacteria are
recombinant organisms and produce insulin in large quantities for diabetics.
Attempts to make rec –insulin started in 1970.
1982-approval for human use. 1986-ELI- LILLY approval to market HUMULIN.
Production steps

5. Vaccine
A vaccine is any preparation of dead or attenuated pathogens or
their products, that when introduced into the body, stimulates the
production of protective antibodies or T-cells without causing the
disease.
The word “vaccine” originates from the Latin Variolae vaccinae
(cowpox), which Edward Jenner demonstrated in 1798 could
prevent smallpox in humans.
Production steps
Step 1: Generation of the antigen
Step 2: Isolation of the antigen
Step 3: Purification
Step 4: Addition of other components
Step 5: Packaging.

6. Protropin (Human Growth Hormone) Production:
Protropin, used to treat children with growth problems stemming from an
inability to produce their own growth hormone.
Production steps:
1. A gene that produces growth hormone in humans is isolated.
2. The growth hormone production gene is inserted into the DNA of
E.Coli bacteria.
3. The bacteria recognise the inserted DNA as its own DNA and begin
to produce human growth hormone.
4. The bacteria multiply and produce the growth hormone in a
culturing media.
5. The growth hormone is extracted and purfied and is then ready to
be injected into children with GHI.

7. Monoclonal antibody (Hybridoma technology):
Monoclonal antibodies were produced in mice using a technique
described by Köhler and Milstein. They were awarded the Nobel Prize in
1984.
Monoclonal antibodies most used for cancer treatment.
Production steps
1. Inject the protein into a mouse.
2. Remove the spleen.
3. Identify which spleen cells are producing antibodies.
4. Separate these cells and grow in tissue culture tubes.
5. Screen each Ab for cross reactivity.- select the Ab which doesnt cross
react with any other protein