Joe Fredette | Authors

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.

Mass spectrometry (MS) is emerging as a critical tool in biopharmaceutical late stage development, manufacturing, and quality control (QC) environments. The rapid growth of biologics in development, the increasing demand for more robust analytical technologies to directly monitor the critical quality attributes (CQAs) of these new drugs, and longer term industry initiatives aimed at improving quality and productivity, such as quality by design (QbD) regulatory submissions and continuous manufacturing, are all fueling a greater need for mass monitoring with MS.