Leachable compounds are currently only evaluated on the toxicological risk they pose to the patient. The effects that leachable compounds have on the quality and safety of pharmaceutical drug products, especially protein drug products, is often overlooked. Interactions of reactive leachable compounds with protein drug products can lead to a loss of efficiency, decrease of stability and increased immunogenicity in the patient population at risk. This webinar describes reactive leachable compounds, the scientific basis to predict leachable-protein interactions and a proof of concept.
