Manufacturing & Analytical Characterization
Amruta Mhashilkar, MD, PhD, MBA
Associate Director, Formulation & Process Development
Catalent
St. Petersburg, Florida
Description: Lipid-based formulations offer proven strategies for enhancing solubility, permeability, and overall bioavailability of challenging drug molecules. Yet, translating a promising lipid formulation from early lab work to clinical implementation requires more than technical feasibility; it demands strategic alignment of formulation science, manufacturing scale-up, and clinical objectives. This session will explore how early-phase formulation refinement, guided by excipient compatibility and physicochemical characterization, lays the groundwork for robust clinical trial material. Attendees will gain insight into practical considerations for scaling lipid systems, managing process variability, and designing formulations that maintain performance through development transitions. Real-world examples will illustrate how lipid-based technologies can accelerate Phase I/II readiness, minimize the risk of costly reformulations, and create a strong foundation for downstream commercialization.