2Department of Pharmaceutics, St. John Institute of Pharmacy & Research, Palghar, India
Keywords: Recombinant DNA; Gene therapy; Antibodies; Applications
It is basically the controlled use of biological agents, such as microorganisms or cellular components for human beneficial use. It is the integrated use of biochemistry, microbiology and engineering sciences in order to exploit microorganisms, cultured tissues/cells, to their best [1,2]. Man has continued his quest for improving the natural capabilities of microorganisms and making them capable of novel processes and to create them for highly valuable cause, for human welfare. Years ago, people exploited micro-organisms for making bread, brewing alcohol and cheese production, although the phenomenon of fermentation was not understood thoroughly. Now, the extent of biotechnological application is more sophisticated. Researchers can manipulate living organisms and transfer genetic material between organisms, generating transgenics (plants/animals). The current applications of biotechnology are predominantly practiced in the field of agriculture and medicine. Modern techniques allow production of new and improved foods. Insect resistant crops have been developed using recent advances in biotechnology [3,4,5]. In the field of medicine, it has resulted in development of newer antibiotics, vaccines for various diseases such as cancer, AIDS, hereditary diseases such as Huntington’s chorea etc. Biotechnology is also being applied in the area of pollution control, mining and energy production (biofuel production). Genetically engineered micro-organism and plants are used to clean up toxic wastes from industrial effluents and oil spills.
The spectacular progress and enormous understanding over the past two decades in biological processes at both molecular and cellular level is revolutionized by the advent of recombinant DNA technology or Genetic engineering. This field of science is broadly spawned under modern biotechnology, which is precisely the usage of living organisms to produce improved and valuable products for human consumption .
The idea of recombinant DNA was first proposed by Peter Lobban, a graduate student of Prof. Dale Kaiser in the Biochemistry Department at Stanford University Medical School . The first publications describing the successful production and intracellular replication of recombinant DNA appeared in 1972 and 1973. Stanford University applied for a US patent on recombinant DNA in 1974, listing the inventors as Stanley N. Cohen and Herbert W. Boyer; this patent was awarded in 1980. The first licensed drug generated using recombinant DNA technology was human insulin, developed by Genentech and Licensed by Eli Lilly and Company Recombinant DNA (rDNA) molecules are DNA molecules formed by laboratory methods of genetic recombination (such as molecular cloning) to bring together genetic material from multiple sources, creating sequences that would not otherwise be found in biological organisms. Recombinant DNA is possible because DNA molecules from all organisms share the same chemical structure [8,9,10].
Germ line gene therapy: Germ cells (sperm or eggs) are modified by the introduction of functional genes. Therefore, the change is heritable and will be passed on to the later generations. This is theoretically highly effective in treating genetic disorders but this option is not considered at present for application in human beings for a variety of ethical reasons.
Somatic gene therapy: The gene is introduced only in somatic cells but it is not herited as germline is not involved. Somatic gene therapy is further divided into two groups: The first one where the functional gene is introduced in addition to the defective gene endogenously that is the modified cell contains both the defective as well as the normal (introduced) copies of the gene. This is called as augmentation therapy. The second is targeted gene transfer, which uses homologous recombination to replace the endogenous gene with the introduced functional gene 
A vast majority of applications of environmental biotechnology use naturally occurring microorganisms (bacteria, fungi, etc.) to identify and filter manufacturing waste before it is introduced into the environment. Bioremediation program involving the use of microorganisms are currently in progress to clean up contaminated air, tracks of land, lakes and waterways. Recombinant technology helps in improving the efficacy of these processes so that their basic biological processes are more efficient and can degrade more complex chemicals and higher volumes of waste materials. Recombinant DNA technology also is being used in development of bioindicators where bacteria have been genetically modified as ‘bioluminescors’ that give off light in response to several chemical pollutants. These are being used to measure the presence of some hazardous chemicals in the environment. Other genetic sensors that can be used to detect various chemical contaminants are also undergoing trials and include sensors that can be used to track how pollutants are naturally degrading in ground water. For example when gene such as the mercury resistance gene (mer) or the toluene degradation (tol) gene is linked to genes that code for bioluminescence within living bacterial cells, the biosensor cells can signal extremely low levels of inorganic mercury or toluene that are present in contaminated waters and soils by emitting visible light, which can be measured with fiber-optic fluorometers .
Recent advances in biotechnology have created many legal issues, particularly under the patent system. Patent represents one of several types of intellectual properties; their ownership confers the right to exclude others from benefitting from the tangible products of a proprietary subject matter. The discovery and initial characterization of any rDNA product of potential therapeutics application are followed by its patenting. The normal duration of a patent is 20 years, which starts from the date of filing. Thus the timing assumes importance in terms of the duration for marketing of a product. If the patent is filed too early, the window of opportunity to market the product as well as the size of the market will be smaller. The Biotech Industry Guide would be useful for industrial approval, regulatory clearance to rDNA product and bio safety aspects [17,18,19]. It would also provide help to scientists in obtaining patents on their inventions in India.
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