FUJIFILM Biotechnologies offers Biologics biochemical and biophysical characterization, potency and GMP testing. This is the analytical service business of an integrated CRO/CDMO.
Profile review: 2026-11-05 · Fields retain their individual source dates. Undisclosed values are not zero; early or historical events do not establish the latest financing. Awards and acquisitions are distinguished from equity rounds.
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Biologics biochemical and biophysical characterization, potency and GMP testing
Integrated CRO/CDMO analytical services
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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.
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