Bill Hartzel
Catalent Pharma Solutions, USA
Title: Mitigating the risk of aseptic filling of biologics
Biography
Biography: Bill Hartzel
Abstract
This presentation will focus on the use of the advanced aseptic filling techniques utilized in blow/fill/seal technology to create a glass free injectables platform for biologics. It will provide details on how the principles of QbD are leveraged in the equipment and process design to dramatically reduce the risk profile and particulate contamination in parenteral filling through control and automation. In addition, the presentation will provide a case study of a model mAb and its compatibility with the BFS vial compared to glass.