Explore analytical evidence for structure, heterogeneity, potency, and comparability.
Distinguish research methods, product-specific results, and regulatory requirements. Method suitability needs molecule-specific evaluation.
Sources, selection, and corrections →The first six companies in this field’s editorial order, not a separate selection or capability ranking. The full directory uses the same data and order.
Manage field companies & order →
Crystal Bio Solutions offers Biologics mass spectrometry, CMC analytics, PK, immunogenicity and biomarkers. Services should be matched to the intended study and assay requirements.
Pharmaron offers Biologics characterization, PK/TK, immunogenicity and biomarkers. This is the analytical service business of an integrated CRO/CDMO.
Lonza offers Biologics analytical development, characterization and GMP testing. This is the analytical service business of an integrated CRO/CDMO.
Solvias offers Biologics characterization, impurities, potency and CMC quality testing. Services should be matched to the intended study and assay requirements.
WuXi Biologics offers Biologics structure, higher-order structure, potency, release and stability. This is the analytical service business of an integrated CRO/CDMO.
ProtaGene offers Protein structure, impurities, potency and analytical comparability. Services should be matched to the intended study and assay requirements.
Original online dates are retained. Guides use accessible articles or abstracts and do not replace reading the paper.
This industry perspective examines native mass spectrometry as a complement to established biopharmaceutical characterization methods. It discusses intact assemblies, binding, stoichiometry, and heterogeneity, while identifying throughput, sensitivity, automation, and access limitations. The authors emphasize integration with analytical workflows rather than universal replacement of existing methods.
Elizabeth Hecht; Esther Martin; Idlir Liko; Andrew Mahan; Aniruddha Sahasrabuddhe; Nastaran N Tajoddin; Iain D G Campuzano
DOI: 10.1080/19420862.2026.2699078
Manually selected historical and recent original announcements, not presented as today’s news. Source dates, including historical dates, are retained.
BioAgilytix reviewed its earlier analytical investment in Morrisville and Hamburg, describing infrastructure for GMP QC, characterization, bioassays, release, and stability programs. This is a May 2026 company update about previously expanded capabilities, not a newly announced November facility opening or independent quality certification.
Original announcement ↗