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.
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 culture on the smallest scale uses petri dishes.
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, ali-quoting, and storing cells at a defined passage and homogeneity for particular uses.
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.
cell lines When cells from the first culture (taken from the organism) are used to make subsequent cultures, a cell line is established.
Thanks to genetic or other manipulations, immortal cell lines can replicate indefinitely.
cellulose A fibrous polysaccharide material, the main ingredient of plant cell walls.
centrifugation Spinning samples at high speeds, using centrifugal force (up to 500,000 times the force of gravity) to separate substances
with very small differences in density or weight.
centrifuge A laboratory or industrial apparatus that separates mixed samples of differing density by spinning them at high speed.
certificate of analysis (COA) A batch-specific document that is used to list test methods and results, including applicable specifications, and a final
Code of Federal Regulations; the US regulations that directly apply to biopharmaceutical development are in Title 21 parts 58, 210, 211, and 600. Parts
50, 56, and 312 apply to clinical trials.
Colony forming units; a measurement of the number of microorganisms present derived from the number of colonies that form in a test culture.
cC MP Current good manufacturing practice; see GMR
change control A system by which changes to facilities, equipment, and processes are documented and approved. The change control system ensures
that changes are evaluated and approved prior to implementation to maintain the facilities, equipment, and processes in a
chaotropic Disrupting the structure of water, macromolecules, or living systems to promote activities that would have been inhibited
by the water, molecules, or systems.
characterization Precisely deciphering and describing an entity's properties (physical and chemical properties in the case of a molecular entity;
genetic and stability properties in the case of a cell line).
charge The electrical state of an atom or molecule, whether positive, negative, or neutral, according to the difference of protons
(positively charged) to electrons (negatively charged).
chelation The binding or holding of a metal ion (such as copper, zinc, cadmium, nickel, or cobalt) by another molecule or by another
part of the same molecule; used in a form of affinity chromatography called "metal chelate chromatography."
chelator A molecule used to bind a metal ion with more than one organic group to form a highly stable structure.
chemical synthesis Anon-biotech method of manufacturing chemicals, including drugs.