Guide to BioTerminology 2nd edition - - BioPharm International


Guide to BioTerminology 2nd edition

BioPharm International

Analytical results (above) are just the tip of the documentation iceberg a biopharmaceutical company must keep in sight. Specifications and SOPs, protocols and production batch records all are required by the regulatory inspectors who will come calling when a BLA is filed.
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 21CFR 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 transgenics).

record Any and all batch or lot-specific information that is recorded, whether on a form, batch record, laboratory notebook or computerized system. GMP records are required to be retained, protected from loss or damage, and made available during inspections.

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., health care 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.

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