Integrated Product & Process Development

During drug product development, science-based design of formulation and manufacturing process is essential for achieving and assuring consistent quality products. This presentation discusses rational product development based on the integrated product and process knowledge. It addresses the importance of fundamental understanding of physicochemical, mechanical and biopharmaceutical characteristics of API, formulation, process and their interactions during product design, development, scale-up and commercial manufacturing with case studies in ensuring consistent quality, robust drug delivery performance and process.