Scott Berger

As a result of the pharmaceutical cGMP for the 21st century and quality by design (QbD) initiatives championed by regulators, the biopharmaceutical industry has been looking for ways to introduce more automated and higher information content analyses into manufacturing, late-development, and quality control (QC). Mass spectrometry (MS-) based attribute monitoring assays have been proposed as key tools to provide the sensitivity, throughput, selectivity, and flexibility required for monitoring critical product and process attributes for biopharmaceutical production and release. Two analytical workflows, subunit multi-attribute monitoring (MAM) and peptide MAM, have emerged to dominate this discussion, and this article is intended to reflect on the active debates over the needs, challenges, and practical limitations for adopting MS-based attribute monitoring for late-development and QC.