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%.
Rybacek
L
L
Process Development and Improvement Department, Interferon Sciences, Inc., New Brunswick, NJ 08901.
D'Andrea
M
M
Tarnowski
S J
SJ
D002846:Chromatography, Affinity; D004591:Electrophoresis, Polyacrylamide Gel; D004926:Escherichia coli / Q000235:genetics; D006801:Humans; D007163:Immunosorbent Techniques; D007370:Interferon Type I / Q000032:analysis* / Q000494:pharmacology; D007962:Leukocytes / Q000032:analysis*; D011994:Recombinant Proteins / Q000032:analysis; D012441:Saccharomyces cerevisiae / Q000235:genetics; D012967:Sodium Dodecyl Sulfate; D012996:Solutions
D007370:Interferon Type I; D011994:Recombinant Proteins; D012996:Solutions; D012967:Sodium Dodecyl Sulfate