By Nilini Ranbaduge, Ying Qing Yu
Monoclonal antibodies remain one of the most important classes of biotherapeutics in development. Some of the product attributes are critical to potency, efficacy, and safety of the molecule – these are termed critical quality attributes (CQAs). Control and monitoring of PQAs and CQAs throughout the product life cycle ensures high quality mAbs that meet regulatory expectations and target product profile requirements.
Additionally, a quality by design (QbD) approach that focuses on establishing the relationship of various manufacturing processes to achieve this target profile benefits directly from the high information content of MAM based analysis. Establishing QbD design space throughout biotherapeutic manufacturing involves implementation of analytical methods that can efficiently monitor these quality attributes across larger sample sets.
Here we demonstrate an end-to-end analytical workflow developed for peptide-based multi-attribute method (MAM). The waters_connect informatics platform provided a compliant-ready environment for automated data acquisition, processing, and reporting of product quality attributes (PQA) for a monoclonal antibody (mAb) standard. The peptide MAM workflow application coordinates a seamless transition between waters_connect apps to track and quantify product quality attributes arising from protein bioproduction and degradation. In this study, these include modifications such as oxidation, deamidation, succinimide modification, glycosylation, C- and N- terminal modifications, and isomerization. Expanding the assay to support purity assessment, the Peptide MAM App also provided new peak detection (NPD) capabilities
against a designated reference sample.