Bioterminology - - BioPharm International



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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)

Liquid formulations are most common for biopharmaceuticals.
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. [From ICH Q8]

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

Formic acid The simplest carboxylic acid, miscible with water and most polar organic solvents, and somewhat soluble in hydrocarbons. It is used in laboratories as a solvent modifier for HPLC separations of proteins and peptides, especially when the sample is being prepared for mass spectrometry analysis.

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 targeting mechanism needed to get the active ingredient to its site of action.

fraction A separate portion of a mixture, often used to describe the part that contains a particular molecular species.

fractionation range The range of molecular sizes that can fit (or diffuse) into the pores of a gel filtration chromatography medium particle.

free radicals Short-lived, highly reactive molecular fragments that are often capable of initiating/continuing chemical reactions by means of a chain reaction mechanism. They are usually formed by the splitting of molecular bonds, which requires energy input. Free radicals act as initiators or intermediates in oxidation, combustion, polymerization, and photolysis.

FT-IR Fourier transform infrared spectroscopy; an analytical method that measures the ability of a sample to absorb different wavelengths of infrared radiation: How much is absorbed at each wavelength indicates the types of chemical bonds present in the molecules of the sample. The Fourier-transformation is a mathematical method used to interpret the vibrations

of functional molecular groups and highly polar bonds. FT-IR produces a "fingerprint" illustrating the vibrational features of all sample components.

functional genomics A method of selecting among the thousands of drug leads that can come out of discovery efforts. Whereas genomics studies the genetic basis of organisms and their diseases, functional genomics challenges drug lead candidates derived from genomic studies with early development-style assays to build as much information as possible about the potential drug into the discovery process.

fusion partner When making a small protein or peptide in E. coli, it is often necessary to produce the protein fused to a larger protein to get high levels of stable expression. The resulting fusion protein must be cleaved (chemically or enzymatically) to yield the desired protein or peptide. The non-product fusion partner is left over and usually thrown away.

fusion protein A protein containing amino acid sequences from each of two distinct proteins. It is formed by expression of a recombinant gene in which two coding sequences have been joined together. Typically, this is accomplished by cloning a cDNA into an expression vector in frame with an existing gene.

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