Bill Hartzel
Catalent Pharma Solutions, USA
Title: Addressing the market demands of parenterals through innovation and risk mitigation that drives reliable supply
Biography
Biography: Bill Hartzel
Abstract
This presentation will focus on the use of the advanced aseptic fi lling techniques utilized in blow/fi ll/seal technology torncreate a glass-free injectable platform for biologics. It will provide details on how the principles of QbD are leveraged inrnthe equipment and process design to dramatically reduce the risk profi le and particulate contamination in parenteral fi llingrnthrough control and automation. In addition, the presentation will provide a case study of a model mAb and its compatibilityrnwith the BFS vial compared to glass.