The strategic use of advanced analytics is an essential element in today’s early-stage product selection and development. This is particularly true for more complex biologics and emerging modalities such as gene therapy, gene editing, and structurally complex conjugated and fusion biologic products.
Establishing critical attribute monitoring methods early in a biologic’s development lifecycle can improve product development, manufacturing, and clinical outcomes. Advantages range from mitigating the risk of manufacturing or process delays, product failures, and negative clinical outcomes to addressing the evolving expectations of the regulatory environment to include appropriate use of available and increasingly advanced analytical methodologies.