Controlling Lipid Impurities from Raw Materials Through Final Drug Product

• Characterize incoming lipid quality using tandem mass spec and HPLC, identify critical impurities, establish acceptance criteria
• Track impurity profiles through formulation process, understand degradation pathways, implement stability-indicating methods
• Demonstrate component stability in final drug product, meet regulatory expectations, ensure product consistency

Speakers:

Meredith Packer

Director, Analytical Development,

Nava Therapeutics