Exploring The Need For Dose-Flexible Manufacturing

BY Logan Howell, Group Lead Multiparticulates Engineering, Lonza, and Kaylee Eyerly, Lead, Multiparticulate Engineer, Lonza

Regulatory expectations around dose optimization are intensifying, particularly in oncology. The FDA's Project Optimus initiative signals a broader shift: sponsors can no longer rely on maximum tolerated dose as a default endpoint, and manufacturing complexity is not considered an acceptable reason to limit dose levels in clinical trials.

For formulation and development teams, this creates real pressure to plan for dose flexibility early, before platform and technology decisions close off options. Written by multiparticulate engineering specialists Logan Howell and Kaylee Eyerly, this executive summary examines how different solid dosage technologies, including lipid multiparticulates, spray layered multiparticulates, and amorphous solid dispersions, compare in their ability to support flexible dosing across a range of clinical scenarios. A case study on encorafenib illustrates what happens when dose flexibility is not planned for from the start, and what a revised approach might look like.

Explore the analysis to see how formulation strategy and clinical design intersect.