An efficient and specific liquid chromatography (LC)-based assay was developed to monitor the production of recombinant HIV-1 trimeric envelope glycoprotein (HIV Env trimer), a candidate vaccine for HIV-1 infection, in cell culture media to support scale-up process development. In this method, titer measurement was achieved by coupling a weak anion exchange chromatography (IEC) column with a size exclusion chromatography (SEC) column. This assay was specific, accurate, precise, and has been qualified for its intended purpose, with a limit of quantification (LOQ) of 10 µg/mL. This tandem separation strategy offered a reliable and timely analytical support to directly monitor the titer of HIV Env trimer during cell growth, without any extra sample purification steps.
Keywords: Cell culture; HIV-1; HPLC; Quantification; Tandem chromatography; Titer; Vaccine.
Published by Elsevier Ltd.