Compatibility Assessment Of Antibody Formulation In BFS Delivery Formats
Authors: Dipesh Shah, Gregory Bleck and Ian J. Collins
Summary: The purpose of this study was to evaluate the compatibility of a model monoclonal antibody (mAb) formulation in glass and BFS stoppered plastic Advasept™ Vials. The biotechnology industry has expressed a strong interest in plastic Advasept™ Vials to reduce surface interaction of the protein, reduce breakage concerns and eliminate the delamination issues with glass vials. In addition, the use of plastics can enable manufacturers to produce flexible designs and leverage advanced aseptic filling techniques utilizing the BFS technology.
However, the selection of an appropriate plastic vial format compatible with protein therapeutics requires knowledge of the vial component chemistry and its impact on protein safety and efficacy. This study evaluated the compatibility of a model monoclonal antibody (mAb) formulation in glass and compared it to the Advasept™ Vials containing uncoated stoppers. The studies evaluated protein potency (UV, activity), stability (SEC, SDS-PAGE, cIEF and Peptide Mapping) in glass and Advasept™ Vials over long-term storage under refrigerated conditions.