Polysorbate degradation is discussed being oxidatively and hydrolytically, via lipolytic activity of enzymes (Lipases) in HCP. We developed an analytical assay to detect and measure lipolytic activity in biopharmaceutical partly purified DS, drug substance (DS) and drug product (DP). The assay was optimized by variation of key parameters. The assay can support the optimization of the downstream purification process in order to remove HCPs with lipolytic activity. Furthermore it can be used to measure lipolytic activity in DS / DP samples and support root cause investigations related to polysorbate degradation.
Apply a method to measure lipolytic activity in drug product and drug substance.
Understand the importance to control host cell proteins with lipolytic activity.
Get insight into the root cause for polysorbate degradation in Biologics drug substance and drug product.