contaminant A foreign agent or material that is not introduced as part of processing, such as airborne particulates or adventitious organisms.
continuous process verification An alternative approach to process validation in which manufacturing process performance is continuously monitored and evaluated.
[From ICH Q8]
Columns for bioseparations are available in a wide variety of dimensions, chemistries, and pore sizes to best meet separation
control group The group of subjects in a controlled study that receives no treatment, a standard treatment, or a placebo.
controlled delivery Drug delivery in which the duration (sustained delivery) and/or the site (targeted delivery) of drug release, action, and
bioavailability are controlled through various physicochemical means designed to provide well-defined pharmacokinetic profiles.
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.
cotl/2DNA A curve that measures genome complexity by determining the time taken for half the DNA in a sample to rean-neal (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).
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
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.
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.
Carboxyl-terminal; the carboxyl terminus of a protein chain, with a free carboxyl group.
culture medium A complex mixture of organic and inorganic materials used as a nutrient system for the cultivation of cells.
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.
Cysteine; one of more than 20 naturally occurring amino acids.
cytokine A protein that acts as a chemical messenger to stimulate cell migration, usually toward where the protein was released. Interleukins,
lymphokines, and interferons are the most common.
cytopathic Damaging to cells, causing them to exhibit signs of disease.
cytoplasm The protoplasm of a cell outside the nucleus (inside the nucleus is the nucleoplasm). Protoplasm is a semifluid, viscous,
translucent mixture of water, proteins, lipids, carbohydrates, and inorganic salts found in all plant and animal cells.
cytostat Something that retards cellular activity and production. This can refer to cytostatic agents or to machinery, such as those
that would freeze cells.
cytotoxic Causing cell death.