Assoc. Prof. Jennifer McManus SSPC A way to approach Biopharmaceutical Stability and Formulation

Jennifer McManus is Associate Professor in the School of Physics at the University of Bristol and a Visiting Associate Professor in Chemical and Bioprocess Engineering at University College Dublin. Formulation of proteins and other biotherapeutics represents a significant challenge. The analytical burden associated with assessing stability and the technical challenges associated with characterisation of both drug substance and drug product requires more time and different expertise than for small molecules. I will discuss how the physico-chemical characteristics of a protein can influence formulation and stability. I will also discuss the challenges associated with development and analysis of high concentration formulations. Formulation of proteins and other biotherapeutics represents a significant challenge. The analytical burden associated with assessing stability and the technical challenges associated with characterisation of both drug substance and drug product requires more time and different expertise than for small molecules. Jennifer McManus, University of Bristol, will discuss how the physico-chemical characteristics of a protein can influence formulation and stability. Also discussing the challenges associated with development and analysis of high concentration formulations.