A brief introduction and historical developments in pharmaceutical biotechnology and its application.

1. Dr. Mahesh Kumar Kataria
Professor, Seth G. L. Bihani S. D.
College of Technical Education, Sri
Ganganagar
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2. Pharmaceutical biotechnology consist of the combination of two
branches which are “PHARMACEUTICAL SCIENCE” and
“BIOTECHNOLOGY”.
DEFINITION:
•PHARMACEUTICAL SCIENCE: The branch of science deals with the
formulation, compounding and dispensing of drugs
•BIOTECHNOLOGY: The application of biological system, living
organisms, or their derivatives in making or modifying products or
processes for specific use.
•Biotechnology means the study (logos) of tools from living things
(Bios).
•The word "biotechnology“ was first used in 1917 by hungarian
agriculture engineer Karl Ereky (Father of Biotechnology) to describe
processes using living organisms to make a product or run a process,
such as industrial fermentations.
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3.  Biotechnology began when humans began to plant their own
crops, domesticate animals, ferment juice into wine, make
cheese, and leaven bread.
 PHARMACEUTICAL BIOTECHNOLOGY : Can simply be define
as the science that covers all technologies required for the
production, manufacturing and registration of biological drugs.
 The aim of this pharmaceutical biotechnology is to design,
produce drugs that are adapted to each persons genetic make up,
which can give the maximum therapeutic effect. Biotechnology
plays an important role in pharmaceutical science most
especially in the pharmaceutical industries by creation of
genetically modified organisms that can be used in industrial
production
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4. The definition of biotechnology can be further divided into
different areas known as red, green blue and white.
 Red biotechnology: This area includes medical procedures such
as utilizing organisms for the production of novel drugs or
employing stem cells to replace/regenerate injured tissues and
possibly regenerate whole organs. It could simply be called
medical biotechnology.
 Green biotechnology: Green biotechnology applies to agriculture
and involves such processes as the development of pest-resistant
grains and the accelerated evolution of disease-resistant animals.
 Blue biotechnology: Blue biotechnology encompasses processes
in the marine and aquatic environments, such as controlling the
proliferation of noxious water-borne organisms.
 White biotechnology: White (also called gray) biotechnology
involves industrial processes such as the production of new
chemicals or the development of new fuels for vehicles.
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5. A distinction is made between ‘non-gene biotechnology’
and ‘gene biotechnology’:
 Non-gene biotechnology: Non-gene biotechnology
works with whole cells, tissues or even individual
organisms. Non-gene biotechnology is the more
popular practice, involving plant tissue culture, hybrid
seed production, microbial fermentation, production
of hybridoma antibodies and immunochemistry.
 Gene biotechnology: Gene biotechnology deals with
genes, the transfer of genes from one organism to
another and genetic engineering
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6. Stages of Biotechnology
 Ancient Biotechnology:
Early history as related to food and shelter, including domestication
 Classical Biotechnology:
Built on ancient biotechnology
Fermentation promoted food production
Medicine
 Modern Biotechnology
Manipulates genetic information in organism
Genetic engineering
 Cell biology: Structure, organization and reproduction
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7. Modern Biotechnology
 Biochemistry: Synthesis of organic compounds, Cell extracts for
fermentation (enzymes versus whole cells)
 Genetics: Resurrection of Gregor Mendel’s findings in 1866
In 1900s: Theory of Inheritance (ratios dependent on traits of parents)
Theory of Transmission factors
In 1902 W.H. Sutton: Chromosomes = inheritance factors
T.H. Morgan –Drosophila melanogaster
 Molecular Biotechnology
Beadle and Tatum (Neurospora crassa): One gene one enzyme
hypothesis.
Charles Yanofsky: colinearity between mutations in genes and amino
acid sequence (E.coli), Genes determine structure of proteins
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8. Hershey and Chase –1952: T2 bacteriophage –32P DNA, not 35S protein
is the material that encodes genetic information
Watson, Crick, Franklin and Wilkins(1953): X-ray crystallography, 1962
–Nobel Prize awarded to three men, Chargaff –DNA base ratios,
Structural model of DNA developed
Scientific foundation of modern biotechnology: based on knowledge of
DNA, its replication, repair and use of enzymes to carry out in vitro
splicing DNA fragments.
 Organismic biotechnology: Uses intact organisms and does not alter
genetic material.
 Molecular Biotechnology: Alters genetic makeup to achieve specific
goals, Transgenic organism: an organism with artificially altered
genetic material.
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9. Applications of Biotechnology
 Production of new and improved crops/foods, industrial chemicals,
pharmaceuticals (Fermentative production of Antibiotics, Amino acids,
Vitamins, Alcohol etc.)
 Diagnostics for detecting genetic diseases
 Production of Monoclonal Antibodies by hybridoma technology.
 Gene therapy
 Vaccine development (recombinant vaccines): bacterial and Viral
Vaccines.
 Enzyme immobilization and their applications in industry, analysis
(biosensors, ELISA etc.)and therapeutics (Artificial Organs)
 Drug Delivery
 Environmental restoration
 Protection of endangered species
 Conservation biology
 Forensic applications: Polymerase chain reaction, finger printing
 Food processing (cheese, beer)
 Transgenic animals
 Transgenic Plants
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10. References:
 Vyas S. P. and Dixit V.K., Pharmaceutical Biotechnology, First Edition,
2005 (reprint), C.B. S. Publishers and Distributors, New Delhi.
 Patil A.S. et al., A Text Book of Pharmaceutical Biotechnology, First
Edition, 2019, S. Vikas and Company, Jalandhar.
 Rajesh Gollapudi and Sujitha Paladugu, Concise course in
Pharmaceutical Biotechnology, First Edition, 2020, S. Vikas and
Company, Jalandhar.
 Bhatia Saurabh and Goli Divakar, Introduction to Pharmaceutical
Biotechnology-Basic Techniques and Concepts, Volume I, July 2018
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11. Important Questions
 What is pharmaceutical biotechnology?
 Discuss various applications of pharmaceutical
biotechnology.
 Who is the father of biotechnology?
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