Guide to BioTerminology 2nd edition - - BioPharm International


Guide to BioTerminology 2nd edition

BioPharm International

chromatography A technique used to separate molecules based on how they tend to bind to various solids, liquids, and gases; based on the differential distribution of the substances between a stationary phase (sticky material such as silica gel or silicic acid, usually contained in a column, tube, or capillary) and a gaseous or liquid mobile phase (a medium that carries the sample through the stationary phase). This very effective technique can separate substances that are nearly identical.

chromophore A molecule that absorbs UV or visible light.

chromosome A long and complex DNA chain containing the genetic information (genes) of a cell. Prokaryotes contain only a single chromosome; eukaryotes have more than one, made up of a complex of DNA, RNA, and protein. The exact number of chromosomes is species-specific. Humans have 23 pairs.

chymotrypsin A digestive enzyme that can cleave peptide bonds.

CIP Clean-in-place; a way to clean large vessels (tanks, piping, and associated equipment) without moving them or taking them apart, using a high-pressure rinsing treatment, sometimes followed by steam-in-place (SIP) sanitization. Chemically cleaning and sterilizing equipment or systems without removing them from their installed location.

clarify To clear liquid of suspended particles through filtration, extraction/precipitation, or centrifugation.

classical pharmaceuticals Small- molecule, nonbiotech drugs produced by chemical synthesis.

clean room A room in which the concentration of airborne particulate matter is controlled at specific limits to facilitate the manufacture of sterile and high-purity products. Clean rooms are classified according to the number of particles per volume of air to meet standards of cleanliness. Contaminants on surfaces and people entering and exiting the room also are controlled.

clearance Demonstrated removal of an impurity or potential contaminant from a product.

clinical development The phases of drug development during which a drug is tested in human subjects, also referred to as clinical trials.

clinical endpoint An indicator (such as blood pressure) measured in a human subject to assess the safety, efficacy, or other objective of a clinical trial.

clinical hold Temporary cessation of a clinical trial by FDA if the agency is concerned about a drug or study protocol. The trial may resume when the problem is solved.

clone To duplicate exactly, whether a gene or a whole organism; or an organism that is a genetically identical copy of another organism.

cloning vectors Methods of transferring desired genes to organisms that will be used to express them. Cloning vectors are used to make recombinant organisms.

CM Carboxymethylcellulose; a weak ion-exchanger that is often coupled to a resin used in charge based separation chromatography. It is a cation exchange resin.

CMC Chemistry, manufacturing, and controls; the section of a BLA, NDA, or IND describing the composition, manufacture, and specifications of a drug product and its ingredients.

CMO Contract manufacturing organization; a company contracted to perform development and/or manufacturing services.

coacervation The process of forming a coacervate (a mass of small particles bound together by electrostatic attraction) by the partial mixing of two or more liquids.

codon A sequence of three nucleotide bases that codes for a specific amino acid.

colorimetry The measurement and definition of unknown colors in terms of standard colors; techniques may be visual, photoelectric, or spectrophotometric; colorimetry is useful in determining the concentration of a chemical with color in a solution by measuring the intensity of the color and relating that intensity to the concentration of the solution.

column A vertical, cylindrical container or vessel often used in separation processes such as extraction, distillation, and chromatography.

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