Challenges and Solutions in Drug Product Process Development from a Material Science Perspective

While it is common that understanding the impact of material attributes on drug product processes is key for designing robust products and processes, the identification of critical process parameters is indeed systematically performed and well understood, but the identification of critical material attributes remains a challenge at various levels. This chapter addresses the challenges associated with material attributes during drug product process development, process modification, and life cycle management. The type of challenges depends on the stage of the product life cycle. In early develpment stages, the main challenge is the limited amount and representativity of raw materials. During life cycle management, the challenge is mainly the batch-to-batch or source-to-source variability. For each of the challenges, a fit-for-purpose solution is presented using industrial case studies. As seen throughout the chapter, material science should not only be considered at development level but also should play an active role during the entire life of a product to ensure process robustness and therefore an improved product quality and undisturbed supply chains to meet patients’ needs.