Expert view: The future of biologics quality – multiple attribute methodology
Characterisation and quality control of proteinbased biotherapeutics has historically been a lengthy and challenging process due to their complexity and inherent heterogeneity.
Sean McCarthy discusses how multiple attribute methodology (MAM) is gaining traction as a novel approach for biologics characterisation.
As analytical approaches and methods have advanced they have been applied with great effect to increase the understanding of product quality attributes (PQAs) and ultimately critical quality attributes (CQAs) to ensure high-quality products that are safe and efficacious. Until recently, mass spectrometry (MS) has been widely used for characterisation efforts; however, as molecules progress through the development and commercialisation process, orthogonal assays have been developed using bridging studies to correlate mass spectrometric results with these assays.