cake The solid sediment that has been compacted in a centrifuge after removal of as much liquid as possible; or the remaining solid
after completion of a lyophilization.
calorimetry Analytical method that measures heat loss or gain resulting from physical or chemical changes in a sample. Differential scanning
calorimetry compares the results of heating a sample to those for heating a reference material—for example, to measure the
temperature at which the sample crystallizes, changes phase, or decomposes.
campaigned production Continuous production of successive batches of the same product.
Corrective and preventive action; a quality system defined by 21CFR820.100; the policies, procedures, and support systems that enable a firm to assure that exceptions are followed up with appropriate
actions to correct the situation, and with continuous improvement tasks to prevent recurrence and eliminate the cause of potential
nonconforming product and other quality problems. [From FDAQSG]
capillary electrophoresis The miniaturized instrumental version of traditional electrophoresis using capillary column technology (that is, tiny fused-silica
tubes with 20 to 100 μm inner diameters) and light-absorbance or fluorescence detection.
capsid The outer protein shell of a virus particle (virion).
carbohydrates Molecules consisting of sugars. The basic carbohydrate units are called monosaccharides, such as glucose, galactose, and fructose.
Monosaccharides can be linked together into what are called polysaccharides (or oligosaccharides) in almost limitless ways.
Oligosaccharides contain a small number (typically three to 10) of component sugars.
carbonyl bond An oxygen atom double-bonded to a carbon atom; the carbon atom then has two additional bonds to attach to the rest of the
carcinogenic Cancer-causing; many agents that are carcinogenic are mutagens (agents that increase the occurrence of mutation).
cascade effects A series of events that result from one initial cause.
catabolites Waste products of catabolism, by which organisms convert substances into excreted compounds.
cation A positively charged ion (having fewer electrons than protons).
Changes being effected; a regulatory submission sent to FDA to notify them of minor changes in a manufacturing process or its control. The sponsor
is permitted to make the changes without waiting for FDA response, and the changes become part of the existing licensed process.
Changes being effected within 30 days; a regulatory submission sent to FDA to request minor changes in a manufacturing process or its control. FDA has 30 days in
which to respond, after which the change is considered approved and the part of the existing licensed process. (See PAS)
Center for Biologies Evaluation and Research at the FDA; CBER regulates vaccines, gene therapy, cellular products, allergenic extracts, antitoxins, antivenins, venoms, and blood and
blood products (clotting factors and plasma derived products).
Charge-coupled device; semiconductors connected so that the output of one serves as the input for the next (digital cameras, video cameras, and optical
scanners all use CCD arrays); a light-sensitive integrated circuit that stores and displays the data for an image.
Rotationally average collision cross-section; The CCS of an ion is used to calculate the area of an ion in the gas phase and expressed in Omega (see also Omega). Omega
can be calculated empirically through the measurement of an ion's drift time as it passes through a gas filled drift tube
or travelling wave ion guide (see also TWIG).
Circular dichroism; the absorption of left and right circularly polarized light, a property of molecules that are optically active. CD spectroscopy
is a form of light-absorption spectroscopy that measures the difference in left and right circularly polarized light absorbed
by a substance. The spectra can be analyzed to learn the different secondary structural types in a protein: alpha helix, parallel
and antiparallel beta sheet, turn, and so on.
Centers for Disease Control and Prevention (Atlanta, GA) an agency of the Department of Health and Human Services. CDC develops and applies disease prevention and control, promotes
environmental health, and provides health education.