Biologics Characterization & CMC Analytics · Industry updates
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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.
FDA announced final guidance on potency assurance for cellular and gene therapies on November 2. Its recommendations integrate manufacturing-process design, material and process controls, in-process testing, and lot-release potency assays. The agency emphasizes product-specific, risk-based strategies across development and commercialization; this is final guidance, not approval of any individual therapy.
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.
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.
