Guide to BioTerminology 2nd edition - - BioPharm International


Guide to BioTerminology 2nd edition

BioPharm International

NIST National Institutes of Standards and Technology; a federal agency that develops and certifies standard reference materials for use in various US industry applications

NMR spectroscopy Nuclear magnetic resonance spectroscopy; an analytical method that generates a spectrum (based on the electromagnetic environment surrounding the nucleus of each atom in a molecule) that serves as the chemical signature of each molecule and aids in structure determination.

nonconformity A deficiency in a characteristic, product specification, process parameter, record, or procedure that renders the quality of a product unacceptable, indeterminate or not according to specified requirements. [FDA QSDG]

Eukaryotic cells have more numerous and more complex organelles than do prokaryotic cells.
norleucine An amino acid, not produced by mammalian cells, but may be produced by many bacteria, especially under conditions of nutrient-poor media. NorLeu may be substituted for Leu when a mammalian protein is expressed in bacterial cells, creating new product variants that may be of safety concern.

N-terminal Amino-terminal or amine terminus; the amine terminus of a protein chain (with a free α-amino group).

nucleic acids DNA or RNA: chainlike molecules composed of nucleotides.

nucleotides Molecules composed of a nitrogen-rich base, phosphoric acid, and a sugar. The bases can be adenine (A), cytosine (C), guanine (G), thymine (T), or uracil (U).

nucleus The largest organelle, an ovoid or sphere that contains all the cell's genetic material and a nucleolus that builds ribosomes.


oncogene A gene that, when expressed, can lead cells to become cancerous, usually by removing the normal constraints on their growth.

OOS Out-of-specifications result. A result that is outside the range of an approved specification. An OOS result must be investigated to determine whether it is due to laboratory error, operator error, or process error; and a judgment made whether the result itself is valid (accurate estimate of the true value of the analyte) or invalid. Usually, confirming an OOS result as valid results in affected lot(s) of product being rejected.

OOT Out of tolerance; refers to equipment or instrument which, when its calibration is checked, is outside of a defined range and requires adjustment or repair. 2. Out of trend; a test result that is unexpected or outside of its historical or statistical trends but within specifications; and must be investigated as a type of exception. The investigation is very similar to an OOS investigation, with the difference that product disposition may not be affected by a confirmed out of trend result.

operon A group of functionally related, adjacent genes that operate as a unit to synthesize functionally related proteins (enzymes). An operon group includes an operator region, a regulator gene, and structural genes equivalent to the number of enzymes in the system.

optimization Determining and implementing process operation at the best possible and most affordable efficiency.

OQ Operational Qualification; Documented verification that all aspects of a facility, utility or equipment that can affect product quality operate to Intended throughout all anticipated ranges.

organelle A structurally discrete component that performs a certain function inside a eukaryotic cell.

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