Quality-By-Design Led Approaches for Manufacturing & Formulation of Phage Therapeutics

Time: 9:10 am
day: Day Two


  • Benefits of using on-line and at-line process analytics for better process monitoring, process optimization and control
  • Utilizing nanoparticle characterization tools coupled with design-of experiments methodology to optimize liquid formulations
  • Mapping QbD elements for phage manufacture focusing on Quality Target Product Profile (QTPP), Critical Quality Attributes (CQAs) of the
    drug substance, and identifying Critical Process Parameters (CPPs) that link to CQAs