Mikart Capabilities Update August 2026: Oral Solid Dose Formulation

Successful oral solid dose development depends on making formulation decisions with commercialization in mind from the outset. This presentation explores how a molecule-focused, phase-appropriate development strategy can reduce scale-up risks and improve the path to market. Key topics include API characterization, quality target product profiles (QTPP), excipient selection, analytical method development, Quality by Design (QbD) studies, and feasibility-scale manufacturing.

The session highlights the importance of integrating formulation, analytical, manufacturing, quality, packaging, and regulatory planning early in development to ensure smooth technology transfer and process validation. Attendees will gain insight into identifying critical material attributes and process parameters, conducting risk assessments, and designing scalable processes that remain robust across equipment, personnel, and commercial production environments. The presentation also examines common scale-up challenges and outlines practical questions sponsors should ask when selecting a development and manufacturing partner.

Ultimately, the webinar demonstrates how building with the end goal in mind can accelerate successful commercialization.