By: Micah Tuttle, Technical Manager, Development Operations, Process & Product Development

In this talk, we demonstrate how intentional, forward-looking drug product design from day one can dramatically accelerate clinical development—eliminating the need for costly, time-consuming reformulations and bridging studies. By embedding flexibility and scalability into the initial design, programs can move rapidly through early clinical phases while preserving a clear path to commercialization.

Leveraging scalable parameters grounded in material properties—and informed by deep formulation expertise—we show how bench-scale methodologies and platform approaches enable rapid development and seamless scale-up of spray dried dispersion (SDD) tablets.

Through a case study, we illustrate how material-sparing strategies and rational design principles enabled efficient clinical entry with the dose flexibility required for early-phase studies, without compromising the robustness expected of a commercial product. We then demonstrate how bench-derived, scalable process parameters support confident scale-up and a truly advanceable product—from first-in-human through commercial launch.

Key takeaways:

• Design for Advancement from Day One
  Embedding flexibility and scalability into early drug product design enables rapid clinical progression while minimizing the risk of reformulation and bridging studies later.
• Bench-Scale Data Can Predict Commercial Success
  Material-property-driven, scalable parameters established at bench scale can confidently guide process scale-up from FIH through commercial manufacturing.
• Platform and Material-Sparing Strategies Accelerate Timelines
  Leveraging platform formulations and rational, resource-efficient approaches enables fast clinical entry with dose flexibility—without sacrificing robustness or commercial readiness.

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Micah Tuttle is a Senior Engineer in the Product and Process Development group at Serán Bioscience. He leads a team of engineers and scientists in formulating and manufacturing tablets – first for in vitro testing, then scaling to demonstrate process robustness and product stability, transferring knowledge for GMP operations, and supporting the manufacture of FIH and later-stage clinical supplies.  His deep knowledge around material properties and behaviors gives him a unique perspective on pharmaceutical powder processing and applying that to the development of dozens of NCEs has made him a subject-matter expert on manufacturing processes including powder blending, dry granulation, and tablet compression. Micah holds Bachelor’s (Materials Engineering) and Master’s degrees (Materials Science) from Arizona State University and has over a decade of experience in industrial process development, high-tech manufacturing, and failure analysis across a range of industries including automotive, semiconductor equipment, and energy storage.