Glossary

Abbreviated drug approval process The process through which a new drug can be approved by the FDA. This process is abbreviated if the drug is proven to be comparable to a drug already on the market (i.e. it is a generic drug) because some of the safety and effectiveness testing that is necessary for a new drug is no longer required.
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Agricultural biotechnology Biotechnology applied to agriculture, combining plant science and genetic technologies to produce transgenic plants. Agricultural biotechnology, as used here, relates more specifically to the production of agriculturally useful products from plants including products for animal health and food manufacturing.
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Apolipoprotein AI (Apo AI) The most abundantly present protein in an HDL particle. Includes the native form of the protein found in most people and the Apo AIMilanovariant.
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Apolipoprotein AIMilano A naturally occurring rare variant form of apolipoprotein AI.
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Aquaculture The farming of aquatic organisms where some form of human intervention enhances the productive output of the population.
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Biopharmaceutical Protein drug, a product candidate which can only be marketed in the U.S. after completion of clinical trials and approval by the FDA.
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Botaneco Botaneco Specialty Ingredients Inc. is a subsidiary of SemBioSys that specializes in the use of non-transgenic oilbodies for personal care products.
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Cardiovascular disease A class of diseases that affect the heart and blood vessels. Cardiovascular diseases consist of a variety of disorders including heart attack, stroke, coronary artery disease, atherosclerosis, arrhythmia (irregular heartbeat) and chronic heart failure.
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Cell-based assay An assay which is performed using cells that are grown outside a living organism.
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Cholesterol A soft, waxy substance found in the fats in the bloodstream and cells of the body. Cholesterol is important for several functions in the body including the formation of cell membranes and some hormones. However, a high level of cholesterol in the blood is a major risk factor for atherosclerosis and heart attack.
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Chymosin A milk-coagulating enzyme found especially in the gastric juice of the fourth stomach of young calves and other ruminants, used in making cheeses and junkets.
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Clinical trials A series of experiments where a drug is given to humans to test the drug’s short-term and long-term safety and effectiveness. Clinical trials are required to obtain approval for new drug products.
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Diabetes Diabetes consists of a number of disorders including Type I and Type II diabetes and gestational diabetes (during pregnancy). Type I diabetes is characterized by insufficient production of insulin by the body. Type II diabetes is characterized by a reduced sensitivity of the body’s cells to the blood sugar lowering effects of insulin and has been linked to obesity.
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Docosahexaenoic acid (DHA) A polyunsaturated omega-3 fatty acid which is found naturally in fish, organ meats, human breast milk and some microalgae.
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Food and Drug Administration (FDA) The U.S. regulatory body that oversees the drug development process. Most drugs cannot be marketed in the U.S. without the approval of the FDA.
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Gamma linolenic acid (GLA) A polyunsaturated omega-6 fatty acid essential in nutrition. GLA serves as a precursor for a number of molecules vital to the maintenance of cell membrane structure and signaling.
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Generic drug A drug product that is comparable to a drug product that is already on the market. A generic drug is equivalent to the marketed drug product in dosage form, strength, route of administration, quality, performance and intended use.
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Genetic engineering A process used to modify an organism through the introduction of foreign genetic material.
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Heart attack A heart attack occurs when blood flow to a portion of the heart muscle is blocked. This is often due to plaque build-up in the coronary arteries. The blockage can result in damage to the heart muscle due to lack of oxygen.
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High density lipoprotein (HDL) A naturally occurring particle that serves to transport cholesterol from the bloodstream to various tissues. Increased levels of HDL have been correlated with decreased risk of atherosclerosis.
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ImmunoSphere™ An immunostimulatory protein feed additive for the aquaculture industry aimed at improving the economics of aquaculture production.
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IND Investigational New Drug Application – the documentation submitted to the FDA to obtain approval to test drugs in patients.
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Industrial Enzymes A number of industries are using enzymes for their processes. These include detergents, textiles, dairy, food and beverage, feed and other industries.
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Insulin A hormone produced by specialized cells in the pancreas (the Islets of Langerhans). Insulin causes most cells in the body to take up and store sugar (glucose) from the bloodstream. Decreased natural production of insulin or increased resistance to the effects of insulin in the body can result in diabetes.
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Nutritional oils Vegetable and fish oils that contain nutritionally beneficial fats (or fatty acids). More specifically, nutritional oils include omega-3 and / or omega-6 polyunsaturated fatty acids that have been shown to have positive health benefits. Omega-3 fatty acids include docosahexanoic acid (DHA) and omega-6 fatty acids include gamma linolenic acid (GLA).
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Oilbody / Oilbodies Naturally occurring spherically shaped particles found within plant seed cells which serve to store the plant cell’s oil fraction.
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OTC Over the counter. Drugs that are available without a prescription.
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Personal care products A group of products that include cosmetics, fragrances, skin and hair care products, oral care products, nutritional supplements and some over-the-counter medications.
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Pharmaceutical products / protein A product candidate which can only be marketed in the U.S. after completion of clinical trials and approval by the FDA.
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Plaque Plaque is a build up of fatty material on the inside walls of arteries of the body. Over time a plaque can rupture resulting in the formation of a blood clot on the plaque. The blood clot can become large enough to block blood flow to the heart, causing a heart attack, or move through the arteries and block blood flow to the brain, causing a stroke.
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Preclinical work A stage in the development of a new drug where data relating to the drug’s safety (or toxicity) and effectiveness is collected before the drug is tested in humans (clinical trials).
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Safflower A thistle like plant widely grown for its seeds that yield valuable oil; SemBioSys’ development and commercial production crop.
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Stroke A stroke occurs when blood flow to a section of the brain becomes blocked. This is often due to plaque build-up in the arteries of the brain. The blockage can result in damage to the brain due to lack of oxygen.
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Therapeutic proteins Proteins that confer a therapeutic effect when introduced into humans or animals.
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Transgenic An organism that has been altered by incorporation of foreign genetic material.
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