169. full validation Establishment of all validation parameters for a method pertaining to particular analyte(s) in a given matrix in accordance with health authority regulations and industry guidelines.
170. functional neutralizing antibody assay A neutralizing antibody binds to distinct functional domains of a therapeutic protein and blocks its activity or function. A functional neutralizing antibody assay detects if neutralizes the drug activity.
the antidrug antibody
171. gas chromatography (GC) Chromatographic technique using a carrier gas, typically helium or hydrogen, as mobile phase, where the injected liquid sample is typically immediately vaporized in the injection port. The walls of the column are coated with a thin viscous liquid layer, the stationary phase, on an inert solid support.
172. gene editing The insertion or deletion of sequences of DNA in a genome.
