Guide to BioTerminology 2nd edition - - BioPharm International


Guide to BioTerminology 2nd edition

BioPharm International

FDAMA FDA Modernization Act; enacted in November 1997, this amends the FD&C Act to improve (facilitate) the regulation of food, drugs, devices, and biological products.

feedstock Also feed or feed stream; most often the raw broth containing particles to be removed that is placed into a laboratory or manufacturing appliance such as a centrifuge or chromatography column.

feed stream Also feed or feedstock; most often the solution fed into a reaction or separation/ purification process.

fermentation Large-scale cultivation of microorganisms or single-celled creatures for industrial purposes, such as to produce therapeutic molecules or specialty foods and beverages.

fermentor A large bioreactor used to grow bacteria or fungi in liquid culture.

fibrinogen A soluble glycoprotein cleaved by thrombin at the site of a wound to yield fibrin (the protein that makes up a blood clot).

fill-and-finish The part of a manufacturing process concerned with packaging a product in its final form.

filter Porous material through which a liquid or gas is passed so that particulates and impurities are held in suspension and removed from the feed stream. Some impurities may pass through.

filtrate The part of a mixture that passes through a filter, also called permeate.

filtration Separation of solid particles from a fluid by passing the mixture through a porous, fibrous, or granular substance.

FISH Fluorescence in situ hybridization; an analytical method in which specific sequences of DNA are labeled with fluorescent molecules, hybridized (amplified), and then detected with a fluorescence microscope.

floc A fluffy aggregate that resembles a woolly cloud.

flocculant A precipitate (floc), sometimes a flaky or fluffy aggregate that resembles a woolly cloud; the aggregation (flocculation) of initially separate cells that form flocs.

flux Usually, the rate of flow. A lower flux means slower flow, usually caused by clogging.

fMet N-formyl methionine, a variant of the amino acid methionine that many bacterial cells can produce. In mammals, fMet results in a strong adverse reaction by the body.

FMEA Failure modes evaluation and analysis. A method used to perform risk assessment and risk mitigation. A unit operation is analyzed, and all the potential modes by which it might fail are mapped out. Then a control strategy is defined to reduce the probability that a given mode of failure will occur. Used in the aerospace and other industries with much success. (See also HACCP)

folding A process in which a protein spontaneously forms into its correct, knotted tertiary structure that is held in place by chemical bonds and by attractive forces between atoms.

follow-on biologic Another term for biosimilar or biogeneric.

for-cause inspection An FDA facility inspection carried out because of specific information such as the results of a sample analysis, observations made during previous inspections, product recall or market withdrawal, consumer or employee complaint, adverse reaction report, or suspicion of fraud. Also, a similar inspection of a clinic or an IRB.

formal experimental design A structured, organized method for determining the relationship between factors affecting a process and the output of that process. Also known as design of experiments. [ICH Q8]

formamide A colorless, oily, hygroscopic liquid used to denature nucleic acids and as a solvent, softener, or chemical intermediate.

formulation The method and process of selecting the components of a mixture; the product of such a process; the form in which a drug is given to patients (tablets or injections, for example); developed in concert with a drug delivery system and tar-geting mechanism needed to get the active ingredient to its site of action.

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