Guide to BioTerminology 2nd edition - - BioPharm International


Guide to BioTerminology 2nd edition

BioPharm International

Coomassie blue dye A sensitive stain for proteins used to visualize the bands in SDS-PAGE; also Coomassie brilliant blue.

COS, CV-1 African green monkey kidney cells, an established cell line that is commonly used for biotechnology.

cosmid An artificially constructed plasmid vector that contains a specific bacteriophage gene, which allows it to carry up to 45,000 base pairs of desired DNA.

cost of goods (COGS) Also referred to as cost of goods sold. A determination of the direct and indirect cost of manufacturing a drug product (or drug substance) including materials, labor, contract services, and overhead. The COGS is used to determine the commercial viability of a product in relation to it's profit, or margin.

cot1/2 DNA A curve that measures genome complexity by determining the time taken for half the DNA in a sample to reanneal (renature); it is measured for any new genome and compared to a standard such as the E. coli genome.

covalent bond Chemical bond in which two atoms share one or more electron(s).

Cp Process capability; a statistical measurement of the relation between the observed variability of a process and the specifications or requirements for individual lots. Computed by dividing the range by the process variability (sigma); a larger number indicates a more capable process.

CPMP Committee for Proprietary Medicinal Products; the EMEA committee responsible for regulating human medical products in the European Union.

Creutzfeld-Jacob disease A rare, progressive, fatal brain disease in humans believed to be caused by a prion; also classical or sporadic CJD.

Contract research organizations may perform the full gamut of research work, from preclinical testing (above) through clinical studies.
critical micellar concentration (CMC) The concentration of detergent at which micelles begin to form; from a practical point of view, the CMC defines the minimum concentration of free detergent that must be present to keep membrane proteins in solution. CMC values are affected by temperature, ionic strength, pH, and buffer composition. The CMC is important in determining whether a detergent can be removed by dialysis. For example, a free detergent molecule may pass through the membrane but the largest micelle will not. (Compare to CMC: chemistry manufacturing, and controls.)

critical process parameter An input parameter (process setpoint) to a unit operation that must be tightly controlled by the operator, either manually or automatically, and which must be kept within a specified range in order to produce output of acceptable quality within specifications. These parameters are identified during process development.

critical quality attribute A quality characteristic that must be controlled within defined limits to ensure acceptable product quality and performance.

CRO Contract research organization or clinical research organization; a company contracted by a sponsor to perform preclinical or clinical pharmaceutical research.

cryoconcentration When a solution is frozen, water freezes as pure ice crystals. The remaining liquid therefore has a higher solute concentration than the original solution.

cryogranulation Use of a stream of liquid nitrogen to quickly create frozen, discrete pellets of a solution such as bulk or final drug formulation.

cryopreservation Maintenance of frozen cells, usually in liquid nitrogen.

C-terminal Carboxyl-terminal; the carboxyl terminus of a protein chain, with a free carboxyl group.

cuvette A transparent or translucent box-shaped container with precisely measured dimensions for holding liquid samples to be put into a spectrophotometer; also such a container with optical surfaces used to mold samples so that their light-absorbing properties can be measured.

Cys Cysteine, one of over 20 naturally occurring amino acids.

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