QbD Approach to Small-Scale Studies to Enable Rapid Spray Drying Scale-Up
Summary: Drug development is a complex journey that requires efficient manufacturing processes across different production volumes. Drug sponsors often face challenges like limited API quantities and tight development timelines, which can hinder the drug development process. In the quest to streamline the drug development process, the industry has increasingly adopted Quality by Design (QbD) principles to enhance efficiency and ensure quality.
In this webinar, industry experts will discuss how QbD strategies can be applied in the systematic evaluation of small batches of spray-dried solid dispersions for oral delivery. By adopting the QbD framework, drug sponsors can gain a deeper understanding of the formulation and process variables, ensuring that the developed spray-dried drug products meet predefined criteria for efficacy and safety. During the webinar, experts will also explain how this strategy has demonstrated its value by maximizing screening efficiency using limited API quantities within a shortened development timeline, effectively bridging the gap between early development and commercial-scale production of poorly soluble drugs. By attending this webinar, attendees will explore how the integration of QbD principles into small-scale spray drying studies can enable the rapid scale-up of spray drying processes.