Guide to BioTerminology 2nd edition - - BioPharm International


Guide to BioTerminology 2nd edition

BioPharm International

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).

cavitation Formation of gas bubbles in a liquid, caused by low pressure.

CBE 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. (See PAS)

CBE-30 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)

CBER Center for Biologics 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).

CCD 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

CD 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.

CDC 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.

CDER Center for Drug Evaluation and Research. The largest of FDA's six centers, CDER regulates prescription and over-the-counter drugs. Following a transfer of responsibility for biologics that began in June 2003, CDER now also regulates therapeutic proteins and monoclonal antibodies for in vivo use, which were formerly regulated by CBER.

CDRH Center for Devices and Radiological Health; the division of FDA responsible for enforcing regulations of medical devices (such as transdermal delivery systems) and diagnostics.

CE Capillary zone electrophoresis; an analytical method in which a mixture is fractionated using charge; analytes are detected using optical density, mass, or other physical properties. Also called CZE.

cell bank A defined population of cells, such as an immortalized cell line, grown by a defined process and cryopreserved in a defined process and within a defined passage number range. The assumption is that each vial from a cell bank is comparable, and when thawed and added to a manufacturing vessel (or an analytical assay), will perform in a consistent way. (See master cell bank, working cell bank)

cell banking Developing, reproducing, aliquoting, and storing cells at a defined passage and homogeneity for particular uses.

Cell culture on the smallest scale uses petri dishes.
cell culture Cells taken from a living organism and grown in the lab (in "culture"). Methods used to grow animal cells in the lab are usually different from those used to grow microorganisms such as bacteria.

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