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quality system A series of processes that are linked together and controlled centrally to increase assurance of product or manufacturing process quality. Term used by FDA, ICH, and ISO to define those systems that are created and maintained by QA to support GMP operations. Examples include documentation, facility, equipment, packaging, and labeling.

quaternary protein structure The defined organization of two or more macromolecules with tertiary structure such as a protein that are held together by hydrogen bonds and van der Waals and coulombic forces.

radiolabeled Covalently labeled with a radioactive isotope or substance.

R&D Research and development; discovering and developing new products; the department within a company that does so.

raw material Term with differing definitions in different documents; commonly means all materials that are used to manufacture a drug substance or drug product, and regulated by 21 CFR 84. (See also components, starting materials).

reanneal The process of renaturing complementary single-stranded DNA molecules to yield duplex molecules.

recall Product recall; the act of locating all units of a given lot of product that have been placed in the distribution chain for human use and "recalling" them, for cause. Recalls are classified based on a risk assessment. (See also withdrawal)

recombinant Refers to DNA (or the protein resulting from such DNA) that has been genetically engineered to contain genetic material from another organism. Genetically altered microorganisms are usually referred to as recombinant, whereas plants and animals so modified are called transgenic. (See also transgenics)

recovery Purifying a molecule of interest from the mix of biological components produced by a biotech manufacturing fermentation or cell culture process.

redox Equilibrium reaction of oxidation/reduction, for example, thioldisulfide exchange, a step used during refolding of recombinant proteins that contain Cys residues, in order to form correct pairing of sulfhydryl groups (–SH) and form stable disulfide (S–S) bonds.

reducing agent A molecule that donates an electron in an oxidation-reduction reaction, which is a chemical change in which one species is oxidized (loses electrons) and another species is reduced (gains electrons). Reducing agents such as active metals (sodium, magnesium, aluminum, and zinc) can be used to take the place of proteins and keep them from being oxidized.

regeneration (of a column) The act of stripping and cleaning a chromatographic resin of any bound product or contaminants, then stabilizing the surrounding environment in preparation for reuse, usually done by a sequence of various solvents or buffers.

regulatory affairs Drug companies must show that their products consistently meet standards set by government agencies and that manufacturing stays within approved boundaries defined in the license application. Regulatory affairs departments document those activities, submit proposals, and follow those proposals through completion or approval. RA provides regulatory strategy, and sets up meetings with regulatory bodies, and determines when formal notification or submissions to FDA and other regulatory bodies are required. RA is also involved during product recalls or withdrawals.

reproductive toxicology Studies of a drug substance in certain animal models to look for any impact on the test animals' reproductive function.

requirements The explicit or implicit needs or expectations of the patients or their surrogates (e.g., healthcare professionals, regulators and legislators); includes not only to statutory, legislative, or regulatory requirements, but also such needs and expectations. [From ICH Q9]

residue An amino acid when referred to as part of a polypeptide chain.

resin Any of several solid or semi-solid inflammable substances, of natural or synthetic organic origin; usually translucent polymers that do not conduct, that break like glass, and that are soluble in ether, alcohol, and essential oils but not in water. The word is used generically to describe chromatographic media, particularly polymer beads.

resolution A measure of the distinguishability of individual elements (the component parts of a mixture, for example). In chromatography, the quality of separation measured in terms of the purity of the resulting component fractions (higher resolution means greater purity).

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