Degradation of surfactants produce free fatty acids that can be monitored and identified using Total Holographic Characterization (THC). Control samples of the free fatty acids oleic acid is compared with enzymatic degradation of polysorbate 80 (PS80) to identify the breakdown products of the surfactant using THC. When PS80 is degraded in the presence of IgG protein aggregate formation is observed. Using THC protein aggregates are distinguished from other contaminants that are found in pharmaceutical manufacturing, including silicon oil emulsion droplets, and breakdown products of PS80 in the sub-visible particle size range of 0.5 μm – 10 μm. THC requires 25-35 L of sample per measurement and measurements can be performed in a matter of minutes. In addition, THC meets all of the requirements for 21 CFR Part 11.
Learning Objectives:
Upon completion, the audience will have better understanding of the role of PS80 degradation on the formation of protein aggregates from experiments conducted in model biologics.
Upon completion, the audience will understand the underlying physics that enables the detection, identification and quantification of protein aggregates, oleic acid and silicone oil contaminants in model biologics.
Upon completion, the audience will understand how total holographic characterization provides structural information about particulate contaminants.
