As programmes progress into Phase 2b and Phase 3, oral solid dose development faces increased pressure. Batch sizes grow, processes become more sensitive and regulatory expectations tighten. This creates a need for stronger process understanding and a clearer view of how early laboratory decisions influence late phase performance.
This presentation explores the scale sensitive steps that underpin consistent product quality, including blending, granulation, compression and coating. The speakers will outline how data generated at laboratory scale can be translated into robust processes that hold up under greater mechanical, material and environmental demands. Approaches using QbD and DoE will be highlighted to show how data driven frameworks support process design and control.
Attention will also be given to planning for late phase requirements earlier in development. Practical insights from real projects will show how development and manufacturing teams can work together to reduce variability, anticipate risk and build processes that are ready for validation and commercial readiness. This will be particularly valuable for organisations preparing to move from early clinical work into late phase manufacture or refining their current scale up strategy.
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