Guide to BioTerminology 2nd edition - - BioPharm International


Guide to BioTerminology 2nd edition

BioPharm International

endoplasmic reticulum A highly specialized and complex network of branching, interconnecting tubules (surrounded by membranes) found in the cytoplasm of most animal and plant cells. The rough endoplasmic reticulum is where ribosomes make proteins. It appears "rough" because it is covered with ribosomes. The smooth endoplasmic reticulum is the site for synthesis and metabolism of lipids, and it is involved in detoxifying chemicals such as drugs and pesticides.

endotoxin A poison in the form of a a fat/sugar complex (lipopolysaccharide) that forms a part of the cell wall of some types of bacteria. It is released only when the cell is ruptured and can cause septic shock and tissue damage. Pharmaceuticals are tested routinely for endotoxins.

engineering batch A batch run at the defined cGMP production scale for the purpose of evaluating the performance of any or all of the unit operations prior to initiating cGMP manufacturing. It is not intended to be released as a fully compliant cGMP batch. An engineering batch may be executed using a batch record, but need not comply with all instructions and requirements.

enthalpy Heat content; enthalpy change of a chemical reaction equals the difference between the heat put into breaking bonds and the heat released by new bond formation.

Very large fermentors are used in bioprocessing to make antibiotics, biopharmaceuticals, and even beer.
environmental monitoring A documented series of sampling and testing performed on controlled environments in order to assure compliance with room classifications. Testing typically includes monitoring of viables and non-viables via standard-ized sampling methods performed at established time intervals.

enzymes Proteins that catalyze biochemical reactions by causing or speeding up reactions without being changed in the process themselves.

EPA Environmental Protection Agency

epithelium (epithelial) The layer(s) of cells between an organism or its tissues or organs and their surrounding environment (skin cells, inner linings of lungs or digestive organs, outer linings of kidneys, and so on).

epitope A molecular region on the surface of an antigen that elicits an immune response and can combine with the specific antibody produced by such a response; also called a determinant or an antigenic determinant.

equivalence Two lots of product are equivalent if, within experimental error, they are essentially equal in purity/impurity, potency, identity, and safety. A more stringent requirement than comparability. (See comparable)

Escherichia coli Bacteria normally found in the intestinal tract and widely used in biochemical and genetic studies and genetic engineering. E. coli is often used as a vehicle for combining a segment of DNA with an unrelated segment, creating continuous DNA that does not occur naturally (recombinant DNA).

eukaryotes Complex organisms, often multicellular, whose cells contain nuclei.

exception A deviation from approved GMP procedure; an out-of-specifications result or unexpected or out of trend result; a customer complaint. Exceptions must be detected, investigated, and managed using quality systems such as CAPA (corrective and preventive action).

excipient A type of raw material that is present in the drug product and thus has direct patient contact; includes inert materials such as bulking agents, stabilizing agents, preservatives, salts, solvents or waters. An excipient must be evaluated for safety in animals, unless it has been approved as GRAS or is on a list of approved excipients.

exclusion limit In size-exclusion (or gel filtration) chromatography, the smallest size or dimension of molecule that is too large to enter the pores on gel particles.

exogenous Developing from outside, originating externally. Exogenous factors can be external factors such as food and light that affect an organism.

express To translate a cell's genetic information, stored in its DNA (gene), into a specific protein.

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