• Overview of LAIs and their benefits as drug delivery system
• Analytical methods development and challenges with high through put and fit for purpose approach for assay and degradation monitoring during LAI technology scouting and in-vitro studies
• Case study of formulation development during selection/screening of LAI technology
• Lessons learned and prospects of LAIs

Long acting injectables have the potential benefits of patience convenience/compliance and improved safety and efficacy. During formulation development for technology selection/screening for in vitro studies, many samples were generated in different matrixes. High through put and complex sample matrix created challenges for analytical method development and in vitro release profiling. In this presentation we will discuss how fast UPLC method and at line UV monitoring using the Lunatic technique were applied to the LAI development of an oncology drug. In vitro release profiles were used to select technology for in vivo studies in animals of various formulations. Take home message: Fast and fit-for-purpose analytical methodology are key to efficient support of early formulation and technology selection/screening of LAI development of pharmaceuticals.

Jason  Huang 

Associate Scientific Director

Bristol-Myers Squibb Company