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Pharmaceutical Biotechnology - Production of Proteins and Biopharming
The use of biotechnology in both medicine and pharmaceutical industries is the most influential developments in the world of technology in this 21st century. In the effort to comprehend biology, to eradicate diseases and maintain a health and vigor, biotechnology has gone a notch higher in surmounting extreme in search of knowledge and manipulation of life. In order to achieve what biotechnology holds for pharmaceutical industries, tools necessary for identification of molecular structures, creation of active molecules and development of novel comprehensive therapies like immunotherapy and cellular or organismal therapy with genetically engineered cells. However, the huge amounts of data and information alone are not sufficient to lead to new molecular entities and novel therapies, since synthesizing millions of compounds will neither fill the universe of potential molecular structures nor allow identification of those three-dimensional structures specifically interacting with targets.

Biotechnology is central in almost all the pharmaceutical processes. It is widely applied to manipulate different biological chemicals to either actively or passively act as therapies to different kinds of conditions. Modern biotechnology is often associated with the use of genetically modified microorganisms such as Escherichia coli or yeast for the production of substances like antibiotics and synthetic insulin. It can also refer to transgenic animals or transgenic plants, such as Bt corn. Certain pharmaceutical products are also manufactured from genetically altered mammalian cells, such as Chinese Hamster Ovary cells (CHO). Another promising new biotechnology application is the development of plant-made pharmaceuticals. In fact biotechnology has made landmark discoveries in the field of diagnostics in the medical industry. For instance, women suffering from breast cancer whose cancer cells express the protein HER2 use Herceptin, the first drug approved for use with a matching diagnostic test.

Production of proteins
In addition to the classical production of naturally occurring proteins, such as insulin, growth hormones, blood-clotting factors, IFNs and growth factors, the new application of techniques in molecular biotechnology has enabled the synthesis of superior proteins through production of artificial genes or through directed evolution.

Insulin production
Production of genetically engineered human insulin was one of the first breakthroughs of biotechnology in the pharmaceutical industry. Insulin was first produced in Escherichia coli through recombinant DNA technology in 1978. This was done by producing artificial genes for each of the two protein chains that comprise the insulin molecule and inserting them into a plasmid. These exogenous insulin genes were then activated by lactose which were then inserted into Escherichia coli bacteria that rapidly produced insulin. It is widely used today as a therapeutic mechanism against patients suffering from diabetes mellitus (DM). More recently, researchers have succeeded in introducing the gene for human insulin into plants and in producing insulin in them, to be specific safflower. This technique is anticipated to reduce production costs thus affordable to patients.

Production of Human Blood Clotting Factors
Initially, blood clotting factors were produced from donated blood that was partially screened of HIV. However, with approval from FDA, production of human clotting factors was enhanced through Recombinant DNA technology. Human clotting factor ix was the first to be produced through recombinant DNA technology using transgenic Chinese hamster ovary cells in 1986. Plasmids containing the Factor IX gene, along with plasmids with a gene that codes for resistance to methotrexate, were inserted into Chinese hamster ovary cells via transfection. As the development in recombinant DNA technology advanced, FDA approved production human blood clotting Factor VIII using transgenic Chinese hamster ovary cells, the first such blood clotting factor produced using recombinant DNA technology.

Production of Antibiotics
Antibiotics are agents that kill bacteria, fungi and other compounds. In the previous years, the search for antibiotics has been largely restricted to well-known compound classes active against a standard set of drug tests. Although many effective compounds have been discovered, insufficient chemical variability (and lack of novel targets and target mechanisms) has been generated to prevent a serious escalation in clinical resistance. Recent advances in genomics have provided an opportunity to expand the range of potential drug targets and have facilitated a fundamental shift from direct antimicrobial screening programs toward rational target-based strategies.

The application of genome-based Technologies such as expression profiling and proteomics will lead to further changes in the drug discovery paradigm by combining the strengths and advantages of both screening strategies in a single program. With these advances in medicinal chemistry, most of today's antibiotics chemically are semi-synthetic modifications of various natural compounds.

Production of Human Growth Hormone.
Production of human growth hormone was first done in 1979 in Genentech using recombinant DNA technology. These scientists produced human growth hormone by inserting DNA coding for human growth hormone into a plasmid that was implanted in Escherichia coli bacteria. This gene that was inserted into the plasmid was created by reverse transcription of the mRNA found in pituitary glands to complementary DNA. Prior to this development, human growth hormone was extracted from the pituitary glands of cadavers, as animal growth hormones have no therapeutic value in humans.

The term molecular pharming or simply pharming refers to the use of genetic engineering to insert genes that code for useful pharmaceuticals into host animals or plants that would otherwise not express those genes, thus creating a genetically modified organism (GMO). This method has also been used to produce useful products in the pharmaceutical industries to produce a number of therapies to different diseases. Unlike the usual genetic engineering processes, this method is considered less demanding in terms of infrastructure and costs. In the 21st century, Proof of concept has been established for the production of many therapeutic proteins, including antibodies, blood products, cytokines, growth factors, hormones, recombinant enzymes and human and veterinary vaccines through pharming. In February 2009 the United States FDA granted marketing approval for the first drug to be produced in genetically modified livestock. The drug is called ATryn, which is an antithrombin protein purified from the milk of genetically modified goats. Additionally, a most recent treatment for Gaucher’s disease has been approved. This drug is produced in cultured transgenic carrots and tobacco cells.
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Biopharming involves the use of genetically modified plants or plant cells to produce proteins of therapeutic value. Plant cell cultures have also been used to produce a vaccine against Newcastle disease virus.Plant cell based approaches include using moss and algae grown in contained bioreactors. Biopharmaceuticals, including PMPs(Plant-made Pharmaceuticals), made using cell culture are subject to EU regulations on medicinal products and contained use.

Researchers have also developed whole plant based production systems for biopharmaceuticals. Plants have been a source of drugs and useful molecules for millennia but only since the advent of biotechnology has it been possible to use plants to produce proteins that are found elsewhere in nature. The first pharmaceutical protein made in plants was human growth hormone.

One of the main challenges of synthesising complex biotechnology derived proteins is producing them on a large scale at a low cost. Plant cell cultures can be used to produce complex human proteins and are often cheaper to maintain than mammalian cells because they require less sophisticated growth media. Both plant and mammalian cell culture systems are limited by the capacity of bioreactors, which are less suitable for large scale production of biopharmaceuticals.

The low cost of a plant-based system makes this technology particularly applicable to developing countries. The issue of how to deliver perishable drugs and vaccines requiring refrigeration to remote areas with poor roads and storage systems is a major obstacle to the treatment of many diseases associated with developing countries.

Despite the benefits of PMPs there are a number of challenges that have so far hindered their commercialisation in Europe. The establishment of good manufacturing procedures and risk assessment within an appropriate regulatory framework is essential to reduce the risks associated with their production. Such risks include contamination of the food chain and the transfer of genes to related plants.
Sasa Milosevic
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Biotechnology is the science which combines biology with technology that is being used rampantly in pharmaceutical sector. This science has proved to be a boon especially in manufacturing of vaccinations and genetic testing.
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