Presented by Prof. Jennifer McManus – University of Bristol
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 discusses how the physico-chemical characteristics of a protein can influence formulation and stability. And also, discusses the challenges associated with development and analysis of high concentration formulations
