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The Therapeutics of Biopharmaceutical Substances

BY: Gayathri Raghavan | Category: Biotechnology-products | Submitted: 2013-03-03 05:05:13
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Article Summary: "The last decade could be rightly called as the 'Age of Biopharmaceuticals' because of the impact biomedical research has had on the molecular mechanisms. Biomedical research started way back in the 1950s when scientists pointed out host of proteins, with therapeutic applications, that were produced in the body naturally..."


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Abstract

The last decade could be rightly called as the "Age of Biopharmaceuticals" because of the impact biomedical research has had on the molecular mechanisms. Biomedical research started way back in the 1950s when scientists pointed out host of proteins, with therapeutic applications, that were produced in the body naturally. The proteins include interleukins and interferon that regulate the immune system and erythropoietin that stimulates the production of RBCs. The advent of genetic engineering and hybridoma technology overcame many obstacles in medical applications marking the beginning of the age of pharmaceutical science. Some of the problems overcome by genetic engineering include availability, engineered therapeutic proteins, product safety, and an alternate to direct extraction of proteins.

Pharmaceutical Substances from Animal Sources

Some of the traditional pharmaceutical medicines are extracted from animal sources where majority are protein-based. Some of the non-protein pharmaceuticals isolated from animals sources are steroid hormones, prostaglandins, and corticosteroids. Examples include insulin, derived from bovine pancreatic tissue, used in treating diabetes mellitus and infertility; prostaglandins, derived from tissues, acts as uterine stimulators ; and glucagon, derived porcine pancreatic tissue, used in treating hypoglycemia to name a few.

Steroid hormones are used in medical application to treat reproductive dysfunctions and are classified into three main types namely androgens, oestrogens, and progesterone.

Pharmaceutical Substances from Plant Sources

Majority of the ancient medicines are plant-derived. According to sources, around 3 billion people across the globe use traditional plant medicines for their healthcare. Nearly thirty percent of the prescribed drugs that are sold in North America contain substances that are extracted from plants. Plants produce a wide range of bioactive substances through metabolic pathways. Further, when treated chemically, these bioactive substances yield a wide array of drugs that have additional therapeutic applications. Examples include aspirin, derived from the white willow tree, acts as an analgesic; caffeine, derived from

Camellia sinensis, increases mental alertness; and vincristine, derived from Catharanthus roseus, used in treating leukemia. Most plant-derived drugs fall under certain chemical families including steroids, glycosides, flavonoids, salicylates, and coumarins.

Pharmaceutical Substances from Microbial Sources

Like plants and animals, microorganisms also produce many secondary metabolites that display strong therapeutic applications. Antibiotics isolated from microorganisms, in the past and present, have had a great impact on human healthcare. The most notable example is the penicillin derived from Penicillium notatum. Today, there are around 100 known microorganism-derived antibiotics worldwide used for various medical applications.

Examples include streptomycin, derived from Streptomyces griseus; gentamycin, derived from Micromonospora purpurea; and Neomycin, derived from Streptomyces spp.

Pharmaceutical Substances from Transgenic Plants

Over the last decade, pharmaceutical substances extracted from transgenic plants have gained a good reputation. Transgenic plants are considered as effective recombinant protein producers for many reasons including, plant cultivation cost is comparatively low; uses inexpensive harvesting equipment; well-established methodologies; and easy scale- up. Examples of proteins extracted from transgenic plants include hirudin, human serum albumin, hepatitis B surface antigen, and interferon α and β.

Drug Discovery Process

Numerous strategies are followed by the pharmaceutical industry to identify and produce new drugs. First, the drug is identified and then subjected to in vitro and in animal testing to characterize the effectiveness and safety of the drug in treating its intended target. Once the pre-clinical trials are completed, the drug developing company applies for regulatory approval from the appropriate government agency to commence clinical trials on humans.

Clinical trials on humans usually take 5 or more years to complete. Once the clinical phase is complete, the drug developing company compiles the clinical data into a report and submits it to the manufacturing/manufacturing authorities. After the clinical report is reviewed by the authorities, the product goes on sale. Also, the regulatory body conducts post-marketing surveillance to check the success of the drug.

Blood Proteins Substances

When talking about traditional biologics, blood proteins play an important role in therapeutic applications. Blood protein-based substances, produced by genetic engineering, are derived from blood products including red blood cells, albumin, hemoglobin, platelet concentrate, and the whole blood.

Vaccines

Certain cell culture systems used in the production of vaccines, (viral, bacterial, and pathogens), includes the Bacillus Calmette-Guérin (BCG), derived from attenuated bacteria, used in immunization against tuberculosis; cholera vaccine, derived from Vibrio cholerae, used in immunization against cholera; anthrax vaccines, derived from Bacillus anthracis, used in immunization against anthrax to name a few.

Advances in genomics have substantially improved biopharmaceutical drug delivery and biopharmaceutical drug development.

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