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| Biosynthesis | The production, by biological synthesis or degradation, of compounds by a living organism (e.g. amino acid synthesis, nucleotide synthesis) |
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| Biotechnology | An industry that creates, develops, and markets a variety of techniques that use living organisms, or substances from those organisms, to make or modify a product by microbial and biochemical processes. A common misconception is that biotechnology refers only to recombinant DNA or gene splicing work. Recombinant DNA is only one of the many techniques used to derive products for organisms, plants, and parts of both for the biotechnology industry. A list of areas covered by the term biotechnology would more properly include: plant tissue culture, cell fusion techniques (especially for the production of monoclonal antibodies), enzyme systems, plant breeding, meristem culture, fermentation, and others. |
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| Biotechnology (ii) | A process of applying genetic engineering (recombinant DNA), hybrid (monoclonal antibody), hybridization (gene probes), bioelectric, etc. to commercial applications in pharmaceutical, chemical, medical diagnostic device, food, animal and plant industries. |
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| Biotechnology (iii) |
Products Large molecules that are not manufactured by means of chemical synthesis but rather produced by means of fermentation and/or recovery, sourced from genetically engineered products |
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| Biowaste Inactivation | The inactivation or "killing" of biological organisms using heat or chemicals. This step is done at the end of the processing to ensure that there are no living organisms remaining in the effluent that is sent to the sanitary sewer system. Heat is usually applied at 130ºC (266ºF) for mammalian cells. Chemicals used include caustic or acid. |
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| BLA (Biologics License Application) | The required application for marketing a biologic product in the United States. Most biopharmaceuticals are biologics. |
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| Blank | A preliminary analysis omitting only the sample to provide an unbiased reference point or baseline for comparison. It is important to minimize extraneous contamination that could be confused with constituents in the sample itself. |
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| Blind Weld | A "blind weld" is defined as a pipe or tube joint welded automatically in which there is no physical way to inspect the weld either visually or with a borescope. Blinding Clinical trial technique in which, to eliminate bias in a research study, subjects and/or clinical investigators remain unaware of which investigational product is provided. |
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| Blood Corpuscle | A cell that circulates in the blood. |
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| Blood Plasma | Blood from which all blood corpuscles, with the exception of platelet cells, have been removed (e.g. by centrifugation) resulting in a clear, straw-colored fluid, which clots as easily as whole blood |
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| Blood Platelets | Small, disc-shaped, metabolically active cells circulating in the blood. They are essential in the blood clotting process since they aggregate to form a plug on the injured surface of the blood vessel. |
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| Blood Serum | The liquid expressed from clotted blood or clotted blood plasma |
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| Blood-Borne Pathogens | Infectious microorganisms that are carried in the blood of infected humans or animals and that can be transmitted through contact with infected blood, body fluids, tissues, or organs. Blood-borne pathogens are implicated in diseases such as malaria, syphilis, brucellosis, tuberculosis, hepatitis B, and AIDS (Acquired Immunodeficiency Syndrome). Workplace transmission of a blood-borne pathogen can occur via accidental inoculation with a contaminated "sharp" exposure through open cuts, skin abrasions, and mucous membranes of eyes and mouth indirect transmission (e.g., touching mouth, eyes, nose or open cuts with contaminated hands). |
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| Blow (Form) Fill, Seal | Refers to machines that combine formation of a plastic container by blow molding, aseptic filling of a liquid product and sealing of the final package. In the U.S., a major company is ALP, or Automatic Liquid Packaging (Weiler Engineering) and in Europe, Rommilog. |
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| Blowdown | The bleeding-off of fixed quantities of accumulated feed water to reduce concentrated impurities. If these impurities are permitted to accumulate, they may pass through the distillation process and contaminate the distillate or foul the distillation system. |
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| Blowdown (ii) | The withdrawal of water from an evaporating water system to maintain a solids balance within specified limits of concentration of those solids. |
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| BME (Basic Medium Eagles) | One of the most common tissue culture media composed of isotonic salts, carbohydrates and vitamins. When combined with animal serum. BME is a good medium for cell proliferation. |
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| BOD (Biochemical Oxygen Demand) | The amount of oxygen required to oxidize the dissolved organic matter in a water sample by aerobic (bacterial) decay. A measure of the oxygen depletion that would result from discharging organic impurities into a waterway. |
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| BOD (Biological Oxygen Demand) | The oxygen used in meeting the metabolic needs of aerobic organisms in water containing organic compounds. |
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| BPC (Bulk Pharmaceutical Chemical) | A pharmaceutical product derived by chemical synthesis, in bulk form, for later dispensing, formulation or compounding, and filling in a pharmaceutical finishing facility. Breakthrough Passage of a substance through a bed, filter, or process designed to eliminate it. For ion exchange processes, the first signs are leakage of ions (in mixed beds, usually Silica) and the resultant increase in conductivity. For organic removal beds, usually small, volatile compounds (Trihalomethanes (THMs) are common in activated carbon). |
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Glossary V2.0 |
