Super Refined excipients for immunology biologics

Supporting mAb stability through informed surfactant selection. Immunology biologics can encounter agitation, interfacial stress and excipient-related impurities during manufacture, transport, storage and administration. These stresses can contribute to protein unfolding, aggregation and loss of the native protein population. Surfactants are widely used to protect monoclonal antibodies from these destabilising effects. However, performance can vary depending on surfactant chemistry and purity grade, as well as the characteristics of the protein being formulated. Through application studies with adalimumab and ustekinumab, Croda Pharma demonstrates how informed excipient selection can support mAb formulation stability across the development of innovator molecules and biosimilars for immunology.