Modern Techniques: Biotechnology in Pharmaceutical Industry

DEFINITION:

Biotechnology, or biotech, is the use of biological research techniques to develop products and
processes derived from living organisms. Biotechnology techniques are applied at the molecular level
and include DNA typing and cloning, genetic manipulation, and gene transfer of plants, animals, and
microorganisms. Biotech products, sometimes called biologics, are products that are created using
recombinant DNA technology. According to the FDA, “biological products can be composed of sugars,
proteins, or nucleic acids, or a combination of these substances. They may also be living entities, such as
cells and tissues.”

SCOPE:

Biotechnology utilizes cellular and biomolecular processes to create technologies and products that help
improve our lives and the nature. By making useful food, such as bread and cheese, and preserving dairy
products, we have done these for many years by now. Recent biotechnology develops breakthrough
products and technologies to fight diseases, reduce our environmental harm, feed the hungry, use less
and cleaner energy, and have safer, cleaner and more efficient industrial manufacturing processes.

So far, more than 250 biotechnology health care products and vaccines have been made available to
patients, many for previously untreatable diseases. More than 13.3 million farmers around the world
use agricultural biotechnology to increase yields, prevent damage from insects and pests and reduce
damage done on environment due to farming. And more than 50 biorefineries are being built across
North America to test and refine technologies to produce biofuels and chemicals from renewable
biomass, which can help reduce greenhouse gas emissions.

1 GENERAL TECHNIQUE, DESCRIPTION, ITS RESEARCH AND DEVELOPMENT

USAGE: Recombinant DNA Technology (Genetic Engineering)

Genetic engineering deals with synthesis of artificial gene, repair of gene, combining of DNA from two
organism (recombinant DNA) and manipulating the artificial gene together with the recombinant DNA
for the improvement of microbes, plants, animals & human being.

Historical Developments

The term genetic engineering initially referred to various techniques used for the modification or
manipulation of organisms through the processes of heredity and reproduction. As such, the term
embraced both artificial selection and all the interventions of biomedical techniques, among them
artificial insemination, in vitro fertilization (e.g., “test-tube” babies), cloning, and gene manipulation. In
the latter part of the 20th century, however, the term came to refer more specifically to methods of
recombinant DNA technology (or gene cloning), in which DNA molecules from two or more sources are
combined either within cells or in vitro and are then inserted into host organisms in which they are able
to propagate.

The possibility for recombinant DNA technology emerged with the discovery of restriction enzymes in
1968 by Swiss microbiologist Werner Arber. The following year American microbiologist Hamilton O.
Smith purified so-called type II restriction enzymes, which were found to be essential to genetic
engineering for their ability to cleave a specific site within the DNA (as opposed to type I restriction
enzymes, which cleave DNA at random sites). Drawing on Smith’s work, American molecular biologist
Daniel Nathans helped advance the technique of DNA recombination in 1970–71 and demonstrated that
type II enzymes could be useful in genetic studies. Genetic engineering based on recombination was
pioneered in 1973 by American biochemists Stanley N. Cohen and Herbert W. Boyer, who were among
the first to cut DNA into fragments, rejoin different fragments, and insert the new genes into E. coli
bacteria, which then reproduced.

Process and Techniques

Most recombinant DNA technology involves the insertion of foreign genes into the plasmids of common
laboratory strains of bacteria. Plasmids are small rings of DNA; they are not part of the bacterium’s
chromosome (the main repository of the organism’s genetic information). Nonetheless, they are capable
of directing protein synthesis, and, like chromosomal DNA, they are reproduced and passed on to the
bacterium’s progeny. Thus, by incorporating foreign DNA (for example, a mammalian gene) into a
bacterium, researchers can obtain an almost limitless number of copies of the inserted gene.
Furthermore, if the inserted gene is operative (i.e., if it directs protein synthesis), the modified
bacterium will produce the protein specified by the foreign DNA.

A subsequent generation of genetic engineering techniques that emerged in the early 21st century
centred on gene editing. Gene editing, based on a technology known as CRISPR-Cas9, allows researchers
to customize a living organism’s genetic sequence by making very specific changes to its DNA. Gene
editing has a wide array of applications, being used for the genetic modification of crop plants and
livestock and of laboratory model organisms (e.g., mice). The correction of genetic errors associated
with disease in animals suggests that gene editing has potential applications in gene therapy for
humans.

Applications

Genetic engineering has advanced the understanding of many theoretical and practical aspects of gene
function and organization. Through recombinant DNA techniques, bacteria have been created that are
capable of synthesizing human insulin, human growth hormone, alpha interferon, a hepatitis B vaccine,
and other medically useful substances. Plants may be genetically adjusted to enable them to fix
nitrogen, and genetic diseases can possibly be corrected by replacing dysfunctional genes with normally
functioning genes. Nevertheless, special concern has been focused on such achievements for fear that
they might result in the introduction of unfavourable and possibly dangerous traits into microorganisms
that were previously free of them—e.g., resistance to antibiotics, production of toxins, or a tendency to
cause disease. Likewise, the application of gene editing in humans has raised ethical concerns,
particularly regarding its potential use to alter traits such as intelligence and beauty.

Controversy

In 1980 the “new” microorganisms created by recombinant DNA research were deemed patentable, and
in 1986 the U.S. Department of Agriculture approved the sale of the first living genetically altered
organism—a virus, used as a pseudorabies vaccine, from which a single gene had been cut. Since then
several hundred patents have been awarded for genetically altered bacteria and plants. Patents on
genetically engineered and genetically modified organisms, particularly crops and other foods, however,
were a contentious issue, and they remained so into the first part of the 21st century.
RESEARCH ARTICLE:

Role of Recombinant DNA Technology to Improve Life

ABSTRACT

In the past century, the recombinant DNA technology was just an imagination that desirable
characteristics can be improved in the living bodies by controlling the expressions of target genes.
However, in recent era, this field has demonstrated unique impacts in bringing advancement in human
life. By virtue of this technology, crucial proteins required for health problems and dietary purposes can
be produced safely, affordably, and sufficiently. This technology has multidisciplinary applications and
potential to deal with important aspects of life, for instance, improving health, enhancing food
resources, and resistance to divergent adverse environmental effects. Particularly in agriculture, the
genetically modified plants have augmented resistance to harmful agents, enhanced product yield, and
shown increased adaptability for better survival. Moreover, recombinant pharmaceuticals are now being
used confidently and rapidly attaining commercial approvals. Techniques of recombinant DNA
technology, gene therapy, and genetic modifications are also widely used for the purpose of
bioremediation and treating serious diseases. Due to tremendous advancement and broad range of
application in the field of recombinant DNA technology, this review article mainly focuses on its
importance and the possible applications in daily life.

Synthesis:
Human life is greatly affected by three factors: deficiency of food, health problems, and
environmental issues. Food and health are basic human requirements beside a clean and safe
environment. The advent of recombinant DNA technology revolutionized the development in biology
and led to a series of dramatic changes. It offered new opportunities for innovations to produce a wide
range of therapeutic products with immediate effect in the medical genetics and biomedicine by
modifying microorganisms, animals, and plants to yield medically useful substances. Most biotechnology
pharmaceuticals are recombinant in nature which plays a key role against human lethal diseases.

In pharmaceuticals, especially, there are serious issues to produce good quality products as the
change brought into a gene is not accepted by the body. Moreover, in case of increasing product it is not
always positive because different factors may interfere to prevent it from being successful. Considering
health issues, the recombinant technology is helping in treating several diseases which cannot be
treated in normal conditions, although the immune responses hinder achieving good results.
References:

Genetic engineering. The Editors of Encyclopaedia Britannica. Retrieved from

Khan, S., et. al. 2016. Role of Recombinant DNA Technology to Improve Life. International Journal of
Genomics. Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5178364/ last
November 17, 2019.

Pharmaceuticals and Biotechnology. 2019. Vault. Retrieved from https://www.vault.com/industries

Scope of Biotechnology, Its Importance and Impacts. Atlas Biotechnology. Retrieved from
http://www.atlasbiyo.com/en/sayfa_31_scope-of-biotechnology-its-importance-and
impacts.html last November 16, 2019.