Catalent Pharma Solutions, USA
Dipesh Shah is a Senior Development Engineer at Catalent Pharma Solutions,USA. He received his PhD in Pharmaceutical Sciences from University of Missouri-Kansas City in 1998. He has seventeen years of experience in development of parenteral and oral formulations and supported global CMC regulatory submissions and commercial launch of globally approved products.
The purpose of this study was to compare he compatibility of a model monoclonal antibody (mAb) formulation in glass and in AdvaseptTM BFS stoppered plastic vials. Th e biotechnology industry has expressed a strong interest in the use of plastic vials to reduce or eliminate problems associated with glass vials such as protein-surface interactions, vial breakage and glass delamination. In addition, the use of plastics can enable drug manufacturers to produce flexible primary container designs and leverage BFS automated advanced aseptic filling techniques. However, the selection of an appropriate BFS-derived plastic vial compatible with protein therapeutics requires knowledge of the vial’s component chemistry, BFS process and its impact on protein safety and efficacy. This study evaluated the compatibility of a model mAb formulation in glass and compared it to AdvaseptTM vials incorporating uncoated stoppers. The studies evaluated protein potency (UV, activity), protein stability (SEC, SDS-PAGE, cIEF, NTA and Peptide Mapping) and leachables (GC-MS, GC-FID, HPLC-UV and ICP-MS) in glass and in AdvaseptTM vials over long-term storage under refrigerated conditions (5°C). Results indicate that the mAb’s stability was comparable in both primary container systems.
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