Introduction
Biotechnology is part of science in which technology is involved in producing or developing biological products; it utilizes biological systems, living organisms, or parts of this to develop or create different products.
History of Terminology:
Hungarian agriculture engineer Károly Ereky (German: Karl Ereky; October 20, 1878 – June 17,
1952) was first coined the term
Biotechnology in the year 1919 in his book “Biotechnolologie der Flieich-,
Fett- und Milcherzeugung in landwirtschaftlichen Grossbetriebe” (Biotechnology
of Meat, Fat and Milk Production in an Agricultural Large-Scale Farm); He was regarded as the ‘Father of
Biotechnology’.
Later American microbiologist Daniel Nathans (October 30, 1928 – November 16, 1999) introduced the methods using enzymes on DNA double helix to profiled out the undiscovered secrets of DNA, in which double helix can be known to the world in future. Thus, addresses as the ‘Father of Modern Biotechnology’
Growth in Pharmaceuticals:
Biotechnology in its broadest sense refers to
the application of the biological organisms, systems, or processes to
manufacturing service industries. Advances in our understanding of
microorganisms and the techniques for manipulating them genetically has
resulted in advantages in quality and precision in the large-scale production
of pharmaceutical.
The low molecular weight
pharmaceuticals were developed based on the structures, whereas
biopharmaceuticals are developed based on the novelty of their action. In the
year 1995, approximately 770 novel drugs from biotechnology were in different
stages of development, and in 1996, the FDA approved 20 recombinant drugs and
vaccines which were released into the market. Example Antihemophilic Factor, Plasma/Albumin Free (MFG. by Wyeth
Pharmaceuticals, Inc); Coagulation Factor IX (Recombinant), Albumin Fusion
Protein (MFG by CSL Behring Recombinant Facility AG), etc.
Historical Perspective:
After 1940, with the industrial production of antibiotics, the fermentation industry underwent tremendous changes in its capabilities.
The situation after 1973 was dramatically changed, new techniques were evolved for recombinant DNA and molecular cloning; Including gene cloning, site-directed mutagenesis, rapid DNA sequencing, hybridoma technology, and monoclonal antibody production, protoplast fusion, and tissue culture techniques, etc.
In the year 1972, the first recombinant molecules were formed by using restriction enzyme digestion to generate DNA fragments and subsequent ligation of fragments by an enzyme ligase.
In 1975, Milstein and Kohler created hybridomas by the fusion of the myeloma cells with antibody-producing lymphocytes from an immunized animal resulting in the production of monoclonal antibodies (i.e. tumor imaging, predetermined specificity, immunodiagnostics, and cancer treatment.)
Use in
Pharmaceuticals:
Biotechnology is applied to the pharmaceutical industry for:
-
Production of proteins products using rDNA
techniques
To the production of monoclonal antibodies
Site-directed mutagenesis
Gene characterization
Hybridoma culture
Transgenic Plants
Scope in Pharmaceuticals:
Biotechnology
only involved in the areas for Prophylaxis includes vaccines and coagulation.
The advances in recombinant DNA technology has occurred in parallel with the development of genetic processes and biological variations. As the development of new technologies has resulted in the production of a large amount of biochemically defined proteins of medical significance and created an enormous potential for pharmaceutical industries. So there have enlightened so many scopes of Biotechnology in the pharmaceutical field; as follows:
- To produce an effective and safer production of both live and killed vaccines with increased response and high specificity through recombinant DNA technology.
- Analyzing in Viral genetics and DNA sequence.
- Identify those regions in the viral genome whose attractions can contribute to the attenuation of viral pathogenicity.
- The ability to directly alter viral structure at the molecular level enables to design of attenuated vaccines systematically rather than relying upon phenotypic selection.
- Identifying the protein component of virus or microbial pathogen, and production of antibodies having the capacity to neutralize infectivity.
Applications:
- Bioactive Molecules as
Pharmaceuticals
A hormone Erythropoietin (Epo) [produced by the kidney in response to hypoxia] is responsible for stimulating the growth and differentiation of RBC precursors in the bone marrow. As the amino acid sequence of Epo is known, The polypeptide produced from rDNA techniques ensuring the purity level in human blood clotting factors VIII and IX., which factors involve supplying proteins of the coagulation cascade to individuals.
The tumor necrosis factor and lymphotoxin are the polypeptides, responsible for properties such as identification and destruction of tumor cells.
Bioactive peptides, used as vaccines, are being produced for hepatitis B, malaria, herpes virus, influenza, and foot and mouth diseases, etc.
- Immunomodulators
In the treatment of cancer, to improve the responsiveness of the immune system, cloned proteins (i.e. immunomodulators) have been employed. Nowadays the genes for many important receptors have been cloned and Structure/function studies of these receptors may lead to the designing of important pharmaceuticals.
- Monoclonal Antibodies
Monoclonal antibodies produced in vitro by hybridoma technology had a tremendous impact on medicine. In the preparation of immunodiagnostic kits or for prophylactic exploitation, monoclonal antibodies have generated enormous potential in different disciplines in a wide range of applications.
- Hybrid Antibodies
Immunotoxins can be produced by elucidating and constructing a single-chain antibody toxin fusion protein in E.Coli, which are specific and more cytotoxic in nature. Presently it has become possible to create active recombinant immunotoxins with a number of other antibodies. Such immunotoxins are used in the treatment of disease involving interleukin-II receptor-positive cells in the treatment of allograft rejection and as a therapeutic agent in the treatment of AIDS.
- Hybrid Antibiotics
Interspecific cloning of genes for antibiotic production makes it possible to express in the same cell two biosynthetic pathways, which normally operate in different organisms, thus producing a hybrid structure different from those produced by eighter parent organisms.
- DNA Probes
For identification of a particular DNA sequence in the clinical material specificity of nucleic acid, hybridization makes possible. Small sequences can able to detect genes or fragments diagnostic of a particular condition or specific agents. DNA probes can be used to identify specific resistant genes in clinical isolation of bacteria, viruses that may be difficult to cultivate routine laboratory identification of pathogens in tissues or body fluids, and diagnosis of genetic diseases.
- Gene Diagnosis and Therapy
Early as the year of
1979, several attempts at gene therapy in human was unsuccessful. But As
failure is the pillar of success, after lots of progress with the developing technologies
for efficient transfer of recombinant genes into cells of humans or experimental
animals. The several disorders can be treated by ‘Gene Therapy’ as follows:
(i)
Immune deficiency
(ii)
Hereditary anemias
(iii)
Organic acidemias
(iv)
Urea cycle defects
(v)
Metabolic defects
(vi)
Disorders of circulating proteins
(vii)
Deficiency of peptide hormone
(viii)
Phenylketonuria, and other inborn errors of amino acid metabolism
(ix) Therapy of cancer
- Microbial Strain Improvement
Protoplast fusion technique has resulted in either enhanced production of antibiotics or in the formation of new hybrid antibiotics. Enhanced yield has also been achieved through genetic manipulation leading to the reduction of feedstock inhibition biosynthetic pathway. More recently, the specific rate of limiting enzyme is genetically engineered to either become desensitized to metabolic inhibition.
- Biosensors
Advantages The advantages or applications are specificities, precision, to analyses concentrations of harmful substances and therapeutic agents present in the body fluids. The combination of biologically active material displaying characteristic specificity with chemical or electronic sensor converts the responses into an electrical signal [i.e. Glucose electrodes]
- Plants and Plant Cell Culture
More than 90 percent of health worlds half million plant species have been never tested for their pharmacological value, only 120 prescription drugs worldwide are based on extracted plant products. There is more efficient way to produce natural plants drugs in large quantities would be by using recombinant DNA techniques.
- Animals and Mammalian Cell Culture
Genetically modification of animal genomes, genetic manipulation, genetically engineered animal, whole organism s must be regenerated from cloned cells. For the production of transgenic experimental animals in animal scale with a short duration of time intervals Genetically modification techniques are used.
- Enzymes
A large number of enzymes have been cloned and expressed for biochemical characterization and at a more remote reasonable and accessible target sides derived from cloned DNAs are subjected to clone an enzyme so that the host produces a novel enzyme. Controlled changes in the polypeptides can be made by chemically synthesizing new, altered genes or by sited directed mutagenesis.
- Drug Delivery
With the exception of monoclonal antibodies, most of the new delivery vehicles are synthetic. Some new drug delivery systems are:
- Bioerodable non-toxic synthetic polymer and microphage: These polymers of 5 to 300 microns have been sued to deliver a drug transdermally.
- Transdermal applications: Nitroglycerine for treating angina and scopolamine for combitating motion sickness have been administered through TDDS.
- Liposomes: Liposomes intercalcated drug formulations using amphotericin B (for treatment of fungal infections), doxorubicin hydrochlorides (anti-tumor, anti-cancer drugs), rifampicin (for treatment of tuberculosis), etc. are, already used.
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