Application of QbD Principles to Late-Stage Formulation Development for Biological Liquid Products

  title={Application of QbD Principles to Late-Stage Formulation Development for Biological Liquid Products},
  author={Alavattam Sreedhara and Rita L. Wong and Yvonne K. Lentz and Karin Schoenhammer and Christopher Stark},
Quality by Design (QbD) is a science- and risk-based approach to drug product development. While many of the same principles have been historically used during development, this knowledge was not always formally documented or proactively submitted to regulators. In recent years, the US Food and Drug Administration has launched an initiative for pharmaceutical quality for the twenty-first century to modernize pharmaceutical manufacturing and improve product quality. In the biopharmaceutical… 
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