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RESEARCH / LITERATURE

Research Literature

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Biologics Characterization & CMC Analytics 2

Duplicate DOIs are merged. This is a selected collection, not an exhaustive bibliography.

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Methods
Communications Chemistry

Direct-infusion method accelerates antibody peptide mapping in a peer-reviewed study

Austin Z. Salome; Marcel Morgenstern; Alexander S. Hebert; Craig D. Wenger; Pavel Sinitcyn; Benton J. Anderson; John S. Chlystek; Lia R. Serrano; Keaton L. Mertz; Ian J. Miller; Erik Miller-Galow; Malika P. Godamudunage; Michael Batt; Bhavin R. Patel; Gihoon Lee; Lloyd M. Smith; Scott T. Quarmby; Alayna M. George Thompson; Joomi Ahn; Harsha P. Gunawardena; Joshua J. Coon

A Communications Chemistry study reports RaPiD-mAb-MS, combining plate-based preparation with direct-infusion mass spectrometry for antibody peptide mapping. The original abstract describes analysis of 96 samples in about 1.5–2 hours, routinely exceeding 95% sequence coverage, across 28 antibodies and more than 2,000 samples. The reported comparisons cover several modifications and sequence variants; broader method suitability still requires evaluation.

Biologics Characterization & CMC Analytics
Read guide →Original paper ↗

DOI: 10.1038/s42004-026-02260-8

Reviews & perspectives
mAbs

Setting expectations for current and future directions of native mass spectrometry in the biopharmaceutical industry

Elizabeth Hecht; Esther Martin; Idlir Liko; Andrew Mahan; Aniruddha Sahasrabuddhe; Nastaran N Tajoddin; Iain D G Campuzano

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.

Biologics Characterization & CMC Analytics
Read guide →Original paper ↗

DOI: 10.1080/19420862.2026.2699078

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