Antibody-drug conjugates (ADCs) are among the most promising—and analytically demanding—modalities in biopharma today. By combining large, heterogeneous antibodies with chemically labile payloads and linkers, ADCs introduce a level of structural complexity that challenges conventional analytical workflows. It also poses the challenge that the very features you need to measure are often the easiest to lose during analysis.
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Unlike traditional monoclonal antibodies, ADCs combine an antibody backbone with linker chemistry and a cytotoxic payload. This multi-component architecture introduces overlapping layers of heterogeneity, including drug-to-antibody ratio (DAR) distributions, charge variants, post-translational modifications, and structural changes at both the intact and subunit levels. Across ADC development, these characteristics are considered critical quality attributes that must be characterized, understood, and monitored.
Antibody-drug conjugates (ADCs) have emerged as one of the fastest-growing classes of biotherapeutics, combining the targeting specificity of monoclonal antibodies with the potency of cytotoxic payloads. However, this unique architecture also introduces significant analytical complexity. From drug-to-antibody ratio (DAR) distributions and charge variants to conjugation sites and structural modifications, ADCs present multiple, interconnected sources of heterogeneity that must be understood to ensure product quality and performance.
As therapeutic pipelines continue to diversify, bioanalysis is being asked to do more than ever before. From small molecules to complex biologics, today’s scientists must generate high‑quality, reliable data across a growing range of molecule types and workflows, often under increasing time pressure.
Glycosylation is one of the more structurally diverse and biologically impactful PTMs in protein therapeutics. Both N‑linked and O‑linked glycans influence protein folding, stability, and biological activity. Given these effects on biotherapeutics, glycosylation is a closely monitored critical quality attribute (CQA). Comprehensive and site‑specific characterization of glycosylation is essential for informed decision‑making throughout drug discovery and development.
Explore why capillary electrophoresis remains essential for high resolution, confident analytics across modern biopharma modalities, from proteins to mRNA and gene therapies
Capillary electrophoresis (CE) is not confined to a single point in the drug development lifecycle. Its value comes from the ability to deliver high‑resolution, reproducible separations that remain relevant as analytical questions evolve, from early discovery through late‑stage development and lot release.
As an analytical strategy, middle-down mass spectrometry (MS) workflows characterize biotherapeutic proteins by analyzing large, digested protein fragments or defined subunits, rather than fully intact proteins (top-down) or digested peptides (bottom-up). A middle-down strategy combines the strengths of top-down and bottom-up approaches by delivering high sequence coverage and structural specificity while maintaining relatively simple sample preparation. In practice, middle-down analysis enables accurate mass measurement, rapid sequence confirmation, and localization of key post-translational modifications (PTMs) on protein subunits that are directly relevant to product quality.