Dosage Form Scale-Up: Balancing Speed And Efficiency In Later-Stage Development

By Markus Weigandt, Global Head R&D Drug Products

Moving from Phase 1 to Phase 2 marks a critical turning point in oral drug product development. As patient populations expand and clinical programs become more complex, formulation strategies must evolve beyond short-term flexibility toward long-term manufacturability, scalability, and commercial readiness.

Successful progression requires more than simply increasing batch sizes. Developers must align drug substance and drug product teams, establish robust tablet formulations, and make early decisions that support large-scale manufacturing and global regulatory requirements. Strategic use of platform formulations, proactive formulation development during Phase 1, and careful consideration of stability and packaging can help reduce risk and accelerate timelines.

The choices made during early development, including API characterization, salt selection, and solid-form assessment, often have lasting consequences. Investing in these foundational activities can prevent costly reformulations, scale-up challenges, and delays later in development. Learn how thoughtful planning and formulation design can help create a smoother path from early clinical success to commercial supply.