3NA

Pharmaceutical
Products
Recombinant DNA Technology
Recombinant DNA (rDNA) is widely used in
biotechnology, medicine and research.

Proteins and other products that result from the use

of rDNA technology are found in essentially every
western pharmacy, doctor’s or veterinarian’s office,
medical testing laboratory, and biological research
laboratory.
Pharmaceutical industry benefits from
the advances in the DNA technology
and genetic research to develop useful
drugs.
The pharmaceutical products of rDNA
technology are broadly divided into following
three types:

1. Human protein replacements

2. Therapeutic agents for human diseases
3. Vaccines
Human Protein Replacements
 Human Recombinant Insulin
Treatment for type 1 diabetes (condition in which the body
does not produce insulin and therefore cannot control the
amount of sugar in the blood).
The gene of interest (ie. Insulin coding gene) is isolated from
β-cell and inserted in opened plasmid. This recombined
plasmid is inserted into suitable host cell (ie E. coli) and now
this recombined host cell starts producing insulin hormone.
 Human Growth Hormones
Treatment for growth hormone deficiency such
as Dwarfism and Turner’s syndrome.
The procedure essentially consists of inserting
HGH gene into E.coli plasmid, culturing the cells
and isolation of the HGH from the extracellular
medium.
Therapeutic agents for
human diseases
 Blood Clotting Factors or
Factor VIII
Infusions of clotting factors help blood to clot
normally.
Treatment of Hemophilia.
They are concentrated into a powder form
that is then mixed with sterile water and
injected.
Recombinant Tissue Plasminogen
Activator
A form of tissue plasminogen activator that is
made in the laboratory.

It helps dissolve blood clots and is used to treat

heart attacks, strokes, and clots in the lungs.
 Interferons (IFNs)
Proteins made and released by host cells in response to
the presence of pathogens such as viruses, bacteria,
parasites or tumor cells.

Used to treat hepatitis B and C, lymphoma (lymph node

cancer), malignant melanoma (skin cancer), genital
warts, hairy cell leukemia (blood cell cancer), and
Kaposi sarcoma (AIDS-related tumor).
 Erythropoietin (EPO)

A growth factor produced in the kidneys that

stimulates the production of red blood cells.

A biopharmaceutical drug given to patients who

have a low hemoglobin related to chronic
kidney disease, cancer or anemia.
These are some Genetically Engineered
Pharmaceutical Products in Therapeutic agents for
human diseases as follows:

Atrial natriuretic peptide

DNase
Tetracenomycins
Vaccines
 Recombinant Vaccines

• Recombinant vaccines are products of

genetic engineering, where a harmless agent
such as yeast, is programed to produce
antigens of harmful pathogens.
 Hepatitis B Vaccine
Composed of highly purified hepatitis B surface
antigen (HBsAg) adsorbed to an aluminum adjuvant.

The antigen is produced from the fermentation of a

recombinant strain of yeast, Saccharomyces
cerevisiae.

Prevention of hepatitis B infection

 DNA Vaccines
• It refers to the recombinant vaccines in which the
DNA is used as a vaccine. The gene responsible for
the immunogenic protein is identified, isolated and
cloned with corresponding expression vector. Upon
introduction into the individuals to be immunized, it
produces a recombinant DNA.
 Advantages
• Low-cost
• High Mass Production
• Develops more effective versions of conventionally
produced pharmaceuticals
• Treatment of several diseases which cannot be
treated in normal conditions
 Disadvantages

Risk of Allergenicity/adverse immune reactions

The chance that the medicine may not work as
expected.
Supply-chain risks
Individuals with immunodeficiency may elicit poor
immune response.
THANK YEW