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