Head Forensic Chemistry Lonza Group Ltd Basel, Basel-Stadt, Switzerland
Presentation Description: Polysorbates are excipients in biopharmaceutical formulations that protect the therapeutic proteins from interfacial stress. The biopharmaceutical industry currently phases a problem due to observed degradation - oxidatively and hydrolytically - of polysorbate in drug product formulations, leading to increased formation of sub-visible and visible particles and to a potential loss of protecting propensity of the surfactant. Interestingly, mitigation of the effects observed in drug product often can be provided already during drug substance manufacturing and compounding. However, a proper analytical toolbox is necessary to spot polysorbate degradation at an early stage and to differentiate the degradation mechanisms. We present an optimized analytical toolbox to control polysorbate quantity and quality (FMA, ELSD, CAD, free fatty acid analysis, peroxide assay, etc.). Additionally we present analytical strategies to be applied for root cause investigations once polysorbate degradation is observed (particle analysis by spectroscopy, fatty acid analysis, assay for detecting lipolytic activity).
...choose the proper analytical methods used for polysorbate analysis.
...understand the difference of analytical methods used to measure the content versus the stability of polysorbate.
...design root cause analyses once polysorbate degradation is observed.