Lecture 01

Pharmaceutical Biotechnology
(PHA412) Lecture: 01
Topic: Basics of Biotechnology
Mohammad Abbas Gani

Lecturer, Department of Pharmacy, IUB
Biotechnology
• The term “biotechnology” was first used in 1917 by a Hungarian engineer, Karl
Ereky, to describe an integrated process for the large-scale production of pigs by
using sugar beets as the source of food.
• Biotechnology is the commercialization of cell and molecular biology. According to

United States National Science Academy, biotechnology is the “controlled use of
biological agents like cells or cellular components for beneficial use”.
• More generally, biotechnology can be defined as “the use of living organisms, cells
or cellular components for the production of compounds or precise genetic
improvement of living things for the benefit of man”.
• In general biotechnology implies the use of microorganisms, plants, and animals or

parts to produce useful compounds. Consequently, pharmaceutical biotechnology
should be considered as biotechnological manufacturing of pharmaceutical
products.
Biotechnology
• The new form of biotechnology, based on profound knowledge of the DNA molecule
and the availability of manipulation technologies of DNA, is frequently described as
“molecular biotechnology.”
• Most traditional pharmaceuticals are low molecular weight organic chemicals (e.g.,
paracetamol, Acyclovir, Misoprostol, Cimetidine).
• In pharmaceutical circles, ‘biologic’ generally refers to medicinal products derived

from blood, as well as vaccines, toxins and allergen products.
• The term ‘biopharmaceutical’ was first used in the 1980s and came to describe a
class of therapeutic proteins produced by modern biotechnological techniques,
specifically via genetic engineering or, in the case of monoclonal antibodies, by
hybridoma technology. Examples of biopharmaceuticals include vaccines, antibodies,
insulin, enzymes, gene therapy, interferons, etc.
Biotechnology
• Though there are no differences in the principles, the technological advancement of
utilizing living cells for the benefit of man differentiates between classical and modern
biotechnology.
• The process of fermentation for the preparation and manufacturing of products such as
alcohol, beer, wine, dairy products, various types of organic acids such as vinegar, citric
acid, amino acids, and vitamins can be called classical biotechnology or traditional
biotechnology. Fermentation is the process by which living organisms such as yeast or
bacteria are employed to produce useful compounds or products.
• Modern biotechnology is based on the ability of recombinant DNA and Hybridoma

technology to genetically alter the cells and organisms—microbes, plants, and animals—
and to use them for different purposes. For example, genetic engineering has allowed us to
transfer the property of a single gene from one organism to another.
Principles of Biotechnology
• Among many, the two core techniques that enabled birth of modern biotechnology
are :
(i) Genetic engineering : Techniques to alter the chemistry of genetic material

(DNA and RNA), to introduce these into host organisms and thus change the
phenotype of the host organism.
(ii) Bioprocess engineering: Maintenance of sterile (microbial contamination-

free) ambience in chemical engineering processes to enable growth of only the
desired microbe/eukaryotic cell in large quantities for the manufacture of
biotechnological products like antibiotics, vaccines, enzymes, etc.
Bioprocess Technology
• Large-scale production of proteins and enzymes can be carried out by applying
bioprocess technology in fermentation.
• Applying the principles of biology, chemistry, and engineering sciences, processes

are developed to create large quantities of chemicals, antibiotics, proteins, and
enzymes in an economical manner.
• Bioprocess technology includes media and buffer preparation, upstream

processing and downstream processing.
• Upstream processing provides the microorganism the media, substrate, and the
correct chemical environment to carry out the required biochemical reactions to
produce the product.
• Downstream processing is the separation method to harvest the pure product

from the fermentation medium.
Basis of Modern Biotechnology
• Modern biotechnology is mainly based on recombinant DNA (rDNA) and
hybridoma technology in addition to bioprocess technology.
• rDNA technology is the main tool used to produce genetically-modified

organisms, including plants, animals, and microbes. In fact, modern biotechnology
began when recombinant human insulin was produced and marketed in the United
States in 1982. The effort leading up to this landmark event began in the early 1970s
when research scientists developed protocols to construct vectors by cutting out
and pasting pieces of DNA together to create a new piece of DNA (recombinant
DNA) that could be inserted into the bacterium, E. coli (transformation). If one
of the pieces of the new DNA includes a gene for insulin or any other therapeutic
protein or enzyme, the bacterium would be able to produce that protein or enzyme
in large quantities by applying bioprocess technology.
rDNA Technology
Basis of Modern Biotechnology
• Another way of preparing human therapeutic proteins, vaccines, and diagnostic
proteins is by hybridoma technology. The first hybridoma experiments were
carried out in 1975. In hybridoma technology, a B-lymphocyte secreting antibody
against a specific antigen is fused with a myeloma cell. The resulting (a cancerous B-
lymphocyte) cell, if injected into a mouse’s abdomen or if cultured in a bioreactor by
applying bioprocess technology, will grow and divide indefinitely, producing large
quantities of the antibody, which can then be harvested. The resulting proteins are
called monoclonal antibodies (MAb) and are most often used in diagnostic kits.
The most famous MAb-containing diagnostic kit is the pregnancy test. In agriculture,
rDNA technology can be used to produce new varieties of crop plants with improved
agricultural and nutritive qualities. Transgenic plants, which are resistant to biotic
and abiotic stresses such as salinity, drought, and disease, have been produced.
Hybridoma
Technology
Role of Biotechnology in Drug and Medicine
• The use of biotechnology in medicine is growing rapidly and is providing us with
opportunities to develop new, more effective drugs and other therapeutics. Studying
the genetics of humans is allowing us to understand what happens when genes go
wrong in inherited diseases, or cancers, and to start to develop new therapies that
treat the genetic cause, not the symptoms. By studying the genetics of viruses, fungi
or bacteria, we can understand how they cause disease and develop better drugs and
antibiotics that target them more specifically.
• Safer, Cheaper Medicines from Biotechnology: Many medicines have

traditionally been extracted from plants, microorganisms, or animals. However, in
many cases, it is not possible to produce the medicines in large enough amounts,
safely, or cheaply enough to treat large numbers of people. Biotechnology offers ways
to produce valuable medicines in larger amounts by ‘cell culture,’ or using genetic
modification to increase the amounts produced, or to make entirely new medicines.
• Medicines from ‘Cultured’ Cells: Many different types of plant, animal, and
human cells can be grown ‘in culture,’ that is, as a suspension of cells in a large
fermentor vessel of liquid that contains all of the nutrients they need, just as
though they were yeasts or other microorganisms. These cells can be treated in
various ways to make them produce large amounts of valuable compounds:
microorganisms grown in this way can produce antibiotics. Plant cells grown in this
way have been used to produce the anti-leukemia drugs vinblastine and
vincristine: these are natural products of the pink periwinkle. Sedatives and heart
drugs (e.g., digoxin from foxglove) have also been produced in plant culture.
• Genetic Modification for Medicine Production: Organisms can be genetically
modified either to increase the amount of medically useful products, such as
antibiotics that they produce, or to produce entirely new medicines.
Microorganisms and plants are both being genetically modified to produce large
amounts of medicines safely and cheaply: genetically-modified microorganisms
containing the gene for human insulin produce a safe and plentiful supply of insulin
for diabetics; while genetically-modified plants are starting to be used to produce
vaccines for a variety of human and animal diseases.

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Pharmaceutical Biotechnology

Mohammad Abbas Gani

• Biotechnology is the commercialization of cell and molecular biology. According to

• In general biotechnology implies the use of microorganisms, plants, and animals or

• In pharmaceutical circles, ‘biologic’ generally refers to medicinal products derived

• Modern biotechnology is based on the ability of recombinant DNA and Hybridoma

(i) Genetic engineering : Techniques to alter the chemistry of genetic material

(ii) Bioprocess engineering: Maintenance of sterile (microbial contamination-

• Applying the principles of biology, chemistry, and engineering sciences, processes

• Bioprocess technology includes media and buffer preparation, upstream

• Downstream processing is the separation method to harvest the pure product

• rDNA technology is the main tool used to produce genetically-modified

• Safer, Cheaper Medicines from Biotechnology: Many medicines have

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