Chapter NO.

INTRODUCTION TO PHARMACEUTICAL BIOTECHNOLOGY

INTRODUCTION TO BIOTECHNOLOGY
Biotechnology:
Biotechnology may be defined as “the technique of using living organisms or any other
biological systems in preparation of drugs and other substances for environmental purposes”
OR
It may also be defined as “use of biological systems, processes or organisms to prepare such
products that improves the quality of human life”
SUBDISCIPLINES OF BIOTECHNOLOGY

• Red biotechnology involves medical processes such as getting organisms

to produce new drugs, or using stem cells to regenerate damaged human
RED tissues and perhaps re-grow entire organs

• (also called gray) biotechnology involves industrial processes such as the

production of new chemicals or the development of new fuels for vehicles
WHITE
• biotechnology applies to agriculture and involves such processes as the
development of pest-resistant grains or the accelerated evolution of
GREEN disease-resistant animals.

• Blue biotechnology, rarely mentioned, encompasses processes in marine

and aquatic environments, such as controlling the proliferation of noxious
BLUE water-borne organisms.

Pharmaceutical Biotechnology:
Genetics:
“The study of heredity that how characteristics & qualities are transferred from generation to
generation by means of genes” is known as genetics
Or
It is defined as “the science of heredity, dealing with resemblances and differences of related
organisms resulting from the interaction of their genes and the environment”
Genomics:
Genomics may be defined as “the study of genes and their functions, and related techniques”.

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PHARMACOGENOMICS
Introduction:
The term Pharmacogenomics is combination of two words “pharmacology” & “pharmaceutics”
which means that it is intersection of pharmaceutics and genetics
It is defined as “the branch of Pharmacology that deals with impact/effect of genetic variation
on patient’s response to drugs”.
Pharmacogenomics is a new field that combines Pharmacology (study of drugs) & genomics
(Study of genes & its functions) which is employed to manufacture safe and effective
medications and dosses that are fitted to an individual’s genetic makeup.
The use of this field limited currently but new studies are under trials. In future
pharmacogenomics can help in creating personalized drug with increased efficacy and safety
by understanding the genetic makeup of an individual. Many different genes effect the trait that
is responsible for a person’s response to drug (both positive & negative reactions are involved).
In past Scientists can’t predict about the response of a person to a drug without having all
knowledge about the gene that is involve in it because they found it difficult to develop gene
tests. But in present the scientists have discover that there is small variation in the DNA
nucleotide base, so the prediction for drug response can be done now.
Pharmacogenomics tests:
Human body has thousands of genes which are inherited from individual’s parents. These genes
control the individual’s characteristics like eye colour, blood type etc. among these genes some
genes control that how an individual body response to drugs. Pharmacogenomics tests are used
to make changes & to determine that whether these genes show effective response to drug or
show side effects.
For determining the best medication for a patient Pharmacogenomic testing is one tool that can
help health care provider. Along with these tests the other factors like age, gender, lifestyle &
medications already taking are also consider for correct treatment. Pharmacogenomic testing
is used to find that which medication is right for the patient. For this a small blood or saliva
sample is taken to determine that whether a medication is effective for patient, which dose is
effective for patient or patient have serious adverse effects from medication.
Each medication is linked with different pharmacogenomic test. Pharmacogenomic test are
only done once for one medication because the genetic makeup does not change with time, but
for another medication another pharmacogenomic test is done.

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 Some Pharmacogenomic Tests
Pharmacogenomic Tests Drugs Uses
VKORC1 and CYP2C9 Warfarin Anticoagulant
TPMT Thiopurines (azathioprine, Autoimmune/Childhood
mercaptopurine, and leukemia
thioguanine)
CYP2C19 Clopidogrel Cardiovascular diseases
UGT1A1 Irinotecan Anticancer
HLA-B*5701 Abacavir HIV
HLA-B*1502 Carbamazepine, phenytoin Epilepsy
CYP2D6, CYP2C9, Some antidepressants, some Psychiatric, Epilepsy
CYP2C19, CYP1A2, antiepileptics (e.g.,
SLC6A4,HTR2A/C phenytoin, phenobarbital,
carbamazepine, valproic
acid)
CYP2D6 Tamoxifen Anticancer

Importance:
Pharmacogenomics can give following benefits
1. More effective medicines
By using this technique Pharmaceutical companies will manufacture such drugs that are based
on enzymes, proteins and RNA molecules related to genes & diseases. This will help in
discovery of new drugs & creating targeted drug for specific disease. It will result in increase
in therapeutic effects and decrease in damage of surrounding healthy cells
2. More safer medicines
To prescribe the suitable drug to patient, physicians analyse the genetic profile of a patient
which is safer than the standard trial-and-error method. This will not only help in finding the
best drug, it will also increase the safety and speed up recovery time. It will also decrease the
chances of adverse effects.
3. Accurate drug dosages
Pharmacogenomics will replace the currently in use methods of dosage calculation that are
based on weight and age. In future it will be based on genetics of a patient that how body
process the drug. This results in increased therapy value & decrease chances of over dose.
4. Better vaccines
If the Vaccines are made from the genetic material (i.e. DNA or RNA) ensures all benefits of
currently available vaccines with minimum or no risks. The vaccines made by
pharmacogenomics technique will be more stable, less expensive, east to store & are more
effectively engineered with many pathogens’ strains at once

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 5. Enhancements in process of the drug discovery and approval
By using genome targets, Pharmaceutical companies will be able to discover more potential
therapies more easily. By using this technique, the cost of clinical trials will be reduced, as this
will target only those individuals that responds to a drug. The drug approval is also eased by
this technique as trials are targeted for specific genetic population groups resulting in greater
degrees of success.
6. Reduce overall healthcare cost
As this technique reduce the number of unsuccessful drug trials, decreases in the number of
occurring adverse drug reactions, reduction in the time/duration a drug takes to get a drug
approved, reduction in effects a disease produces (as it is early diagnosed), decrease in the
duration of patient’s treatment and the number of medications for effective treatment. This all
will result in reduced healthcare cost.

1.Enhancements
1.More effective 1.More safer 1.Accurate drug 1.Better in process of the 1.Reduce overall
medicines medicines dosages vaccines drug discovery healthcare cost
and approval

Gene Therapy

Gene Therapy And Nucleic Acid Therapeutics

TECHNIQUES USED IN PHARMACEUTICAL BIOTECHNOLOGY
There are many different techniques used in biotechnology but in pharmaceutical
biotechnology three techniques are mostly in use these are
1. Polymerase chain reaction (PCR)
2. DNA Sequencing
3. Affinity Protein Purification

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 Techniques Used In Pharmaceutical
Biotechnology

1.Polymerase chain reaction (PCR)

1.DNA Sequencing

Affinity Protein Purification

1. POLYMERASE CHAIN REACTION (PCR)

Polymerase chain reaction (PCR) is a method that is used to make many copies of a specific
segment/region of DNA quickly and accurately. This technique enables researcher to obtain
increase number of DNA which are required for different experiments & procedures done in
forensic analysis, molecular biology, medical diagnosis & treatment

.Requirements of PCR

TEMPLATE
PRIMERS FREE THERMAL
the purified, TAQ DNA CYCLER
double- short synthetic POLYMERASE NUCLEOTIDES
stranded piece DNA molecules the building a specialized
thermostable
of DNA we want that target a blocks of DNA machine that
enzyme used to
to copy specific DNA rapidly heats
copy DNA
sequence for and cools the
amplification samples.

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Taq Polymerase:

It is a heat stable DNA polymerase. In 1976 it is isolated from the thermophilic bacterium
“Thermus Aquaticus” and that’s why it is named so. It is also abbreviated as “Taq pol” or
simply “Taq”.

The use of taq pol gives following benefits in PCR:

 Enables PCR to run at high ~60 °C and above.

 Facilitates high specificity of the primers.
 Reduces the production of nonspecific products, such as primer dimer.
 Eliminates the need to add new enzyme to each round of thermocycling.

PCR Primer:

Primer is a short sequence of nucleotide that act as a starting point for DNA synthesis, Taq pol
also require a primer for making DNA. The DNA region to be copied by the primer is
determined by the experimenter. In each PCR reaction two primers are used, they are designed
so that they can copy the desired region. They are given such sequences that will make them
able to bind to opposite strands of DNA template, just at the edges of the region to be copied.
The primer binds to the template by complementary base pairing. When the primers are bound
to the template, they can be extended by the polymerase, and the region that lies between them
will get copied.

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STEPS OF PCR

The key ingredients of a PCR reaction are Taq polymerase, primers, template DNA, and
nucleotides (DNA building blocks). The ingredients are assembled in a tube, along with
cofactors needed by the enzyme, and are put through repeated cycles of heating and cooling
that allow DNA to be synthesized.

The basic steps are:

Denaturation Annealing 5OC Extension 72OC

96oC

1. Denaturation:

To separate the DNA, it is heated at high temperature, which denatures it and provide a single
stranded template for further steps.

2. Annealing:

The reaction is cooled, so that the primers will bind to their complementary sequences on the
DNA single-stranded template.

3. Extension:

After cooling, the temperature is again raised so that the Taq pol extends the primers and
synthesize new DNA strands.

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https://www.dictionary.com/browse/biotechnology
https://whatis.techtarget.com/definition/biotechnology
https://www.collinsdictionary.com/dictionary/english/genetics
https://www.who.int/genomics/geneticsVSgenomics/en/
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3299179/
https://ghr.nlm.nih.gov/primer/genomicresearch/pharmacogenomics
http://mayoresearch.mayo.edu/center-for-individualized-medicine/drug-gene-testing.asp
https://labtestsonline.org/tests/pharmacogenetic-tests
https://www.khanacademy.org/science/biology/biotech-dna-technology/dna-sequencing-pcr-
electrophoresis/a/polymerase-chain-reaction-pcr
https://en.wikipedia.org/wiki/Taq_polymerase

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