Enabling Broader Adoption of MAM: Comparison of MAM vs. Conventional Methods

Over the past few years, the mass spectrometry-based Multi-Attribute Method (MAM) has gained traction due to its potential to streamline lab work and decrease development time. However, several barriers to adoption remain, one of which is evaluating performance of MAM vs. conventional methods.  

To evaluate the performance of MAM vs conventional methods, adalimumab and etanercept were procured from multiple sources, and subjected to forced degradation to generate a range of modifications. Samples were analyzed using both conventional and MAM approaches to evaluate size variants, charge variants, glycosylation, sialic acid content, and other molecular variants like oxidation, deamidation, and glycation.

The ability of each technique to detect differences between nominally similar products and forced degradation-induced changes was evaluated. Physiochemical differences were compared to functional and structural changes detected using cell-based assays, binding assays, and circular dichroism. The knowledge base from this study can help lower the barrier to adoption of MAM, enabling greater efficiency and reducing costs.  

Presented by Diane McCarthy, Senior Director, Science and Standards, Global Biologics Department at US Pharmacopeia.

Dr. McCarthy is Senior Director, Science and Standards in the Global Biologics Department at the US Pharmacopeia. She leads development and maintenance of standards and tools to support quality of medicines and oversees the USP biologics laboratories in the US and India. Her team supports a diverse range of biological therapies, including monoclonal antibodies and other protein therapeutics, vaccines, peptides, and cell and gene therapy. Prior to joining USP, Diane worked for several small CROs that focused on the use of mass spectrometry for characterization of biologics, host cell proteins, and biomarkers. Dr. McCarthy earned her Ph.D. in Biochemistry from the University of Texas at Austin.