Why glycan characterization is critical in biopharmaceutical development 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...
Read time: 2 minutes When molecules evolve, analytical certainty must keep up Biopharma development has changed dramatically over the past decade. Molecules are larger, more complex, and more diverse than ever, from highly engineered proteins and conjugates to long...
Read time: 4 minutes 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...
Read time: 6 minutes 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...
Read time: 4 minutes In biopharmaceutical development, sequence variants (SV) are considered an inherent risk of producing complex proteins in living systems. Sequence variants are unintended changes to the amino acid sequence of a biotherapeutic and can be caused by...
CE‑SDS remains a cornerstone assay for characterizing fragmentation, aggregation, and product‑related impurities in therapeutic proteins. UV detection has been the long‑standing standard. However, it frequently struggles with baseline noise, limited sensitivity for...
Read time: 3 minutes A familiar assay with a new way to see more. In monoclonal antibody (mAb) development, assessment of purity and integrity of the protein in question is critical. CE‑SDS is the gold standard assay and is routinely run from analytical development...
Read time: 5 minutes Monitoring product quality attributes (PQAs) throughout monoclonal antibody (mAb) development is vital to ensuring drug safety and efficacy. By adopting orthogonal analytical techniques and integrating new technologies that have the potential to...
Read time: 5minutes What better to learn how a new technology like icIEF-UV/MS is advancing drug development than hearing from the labs that are using it? Kristen Nields, Senior Scientist at The Janssen Pharmaceutical Companies of Johnson & Johnson sat down with...