While it is widely acknowledged that comprehending the impact of material attributes on drug product processes is crucial for designing resilient products and processes, the systematic identification of critical process parameters is well-established and understood. However, the identification of critical material attributes poses a persistent challenge across different levels. This chapter delves into the complexities associated with material attributes throughout drug product process development, process modification, and life cycle management. The nature of these challenges varies depending on the stage of the product life cycle.
In the early stages of development, the primary challenge revolves around the limited quantity and representativeness of raw materials. Conversely, during life cycle management, the predominant challenge lies in the variability from batch to batch or source to source. To address each challenge, the chapter presents fit-for-purpose solutions, drawing on industrial case studies. The overarching theme throughout the chapter underscores that material science should not be confined to the development phase alone but should actively contribute throughout the entire life of a product. This ongoing involvement is crucial for ensuring process robustness, thereby enhancing product quality and maintaining uninterrupted supply chains to meet the needs of patients.