Biopharma

ADC analytics FAQs: Answering the most common questions about ADC characterization

by Roxana McCloskey | Aug 14, 2026 | Biopharma, Blogs

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.

Bioanalysis across modalities: Advancing confident decisions with modern LC‑MS strategies

by Kirsten Craven | Jul 22, 2026 | Biopharma, Blogs, Pharma

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.

Confident glycan characterization with EAD‑enabled LC‑MS workflows

by Roxana McCloskey | Jun 30, 2026 | Biopharma, Blogs

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.

Why capillary electrophoresis still matters in modern biopharma

by Roxana McCloskey | Jun 9, 2026 | Biopharma, Blogs, CE

Explore why capillary electrophoresis remains essential for high resolution, confident analytics across modern biopharma modalities, from proteins to mRNA and gene therapies

Where does capillary electrophoresis fit across drug development?

by Roxana McCloskey | Jun 9, 2026 | Biopharma, Blogs, CE

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.

Why middle‑down and subunit MS analyses powered by EAD are transforming biopharmaceutical characterization

by Roxana McCloskey | May 15, 2026 | Biopharma, Blogs

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.

Why electron-activated dissociation (EAD) improves sequence variant analysis in biopharma LC/MS workflows

by Roxana McCloskey | Apr 29, 2026 | Biopharma, Blogs

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 errors in transcription or translation in the host cell, or cell culture and process conditions. Detailed analysis of SVs is important in process and product development to ensure the drug’s safety and efficacy. Even low‑level sequence variants can have significant implications for product quality, safety, and efficacy, making their accurate detection and characterization a critical requirement across development, process optimization, and regulatory submission.

How NFD improves impurity detection and peak integration in CE SDS workflows

by Roxana McCloskey | Apr 28, 2026 | Biopharma, BioPhase 8800 system, Blogs

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 minor fragments, and subjective integration.

CE‑SDS in monoclonal antibody therapeutic development

by Roxana McCloskey | Mar 31, 2026 | Biopharma, BioPhase 8800 system, Blogs

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 through QC and lot release. It’s trusted because it consistently delivers quantitative, size‑based insight into purity and fragmentation, and it fits naturally into regulated environments.

Predictable uptime starts with a predictable service strategy

by Andrea Mueller | Mar 18, 2026 | Biopharma, Blogs, Clinical, Environmental / Industrial, Food / Beverage, Forensic, Life Science Research, Pharma, Service, Support, Technology

In analytical laboratories, performance is not optional. Whether supporting regulated pharmaceutical workflows, high-throughput CRO operations, clinical reporting, or food and environmental testing, your mass spectrometry and capillary electrophoresis systems are critical to productivity, compliance, and scientific confidence.

Biologics characterization pose many challenges due to the diversity of the biomolecules. Learn about the many powerful tools that allow researchers to fully characterize and quantify their biologic drugs, using mass spectrometry and capillary electrophoresis instrumentation.

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