Rapid dual-column chromatographic assay for recombinant leukocyte interferon alpha-2

A rapid dual-column chromatographic assay for determining recombinant leukocyte interferon alpha-2 in complex mixtures is described. The assay relies on the use of a high-performance monoclonal antibody affinity column connected in tandem with a reversed-phase column. The high specificity and selectivity of these columns permits the quantitation of subcomponent species, such as interferon oligomers that may be present in assay samples. The assay has a limit of sensitivity equal to 1 microgram/g over a range of 1-20 micrograms/g. The precision of the assay was estimated to be about 5%.