Applications of correlative analysis for chemistry, manufacturing and controls in cell and gene therapy.

Correlative analysis is widely used in drug product development and manufacturing to explore the potential associations between attributes of interest. The manufacturing and control of cell and gene therapy (CGT) products are often affected by multiple factors, such as limited knowledge of product characteristics, variable starting materials, complex manufacturing and limited manufacturing experience. Understanding of correlations among process, product and clinical outcome parameters can support process optimization and improve product quality. In this paper, we review the applications of correlative analysis and discuss their implications in CGT product development and manufacturing. We also discuss the unique challenges associated with performing correlative analysis in CGT. Finally, we provide a summary of statistical techniques commonly used to identify associations among attributes related to Chemistry, Manufacturing and Controls (CMC) and clinical outcome. This review aims to provide insights into the effective use of correlative analysis to enhance the development and manufacturing of CGT products.