Title : Capillary electrophoresis for adjuvanted multivalent recombinant vaccine purity determination
Abstract:
Gardasil® and Gardasil®9 are multivalent recombinant vaccines consisting of adjuvanted virus-like particles (VLP) assembled from monomers of the main structural protein (L1) of the human papilloma virus (HPV) expressed in Saccharomyces cerevisiae yeast. The critical quality attributes of purity and L1 intact monomer are currently measured for release and stability by SDS-PAGE for multiple process intermediates varying widely in protein concentration, ionic strength, and matrix composition. The goal was to explore capillary gel electrophoresis (CE-SDS) as an alternative purity method given that the platform has become well-established in the manufacturing space for other large molecules. The complex nature of vaccine samples posed a challenge for CE injection and quantitation which necessitated sample pre-treatment—namely the adjuvanted drug substance which required dissolution. CE-SDS shows good alignment with the SDS-PAGE % purity and % intact monomer values across all HPV genotypes.
