AlpinaBioTech

Empowering Precision Diagnostics

Bringing ImmunoGuide ELISA technologies to Europe and beyond

Validated ELISA kits for therapeutic drug monitoring and anti-drug antibody detection, for clinical labs, research institutions, and biotech teams. For Research Use Only.

Bringing ImmunoGuide ELISA technologies to Europe and beyond

From our journal

Background on ELISA methods, therapeutic drug monitoring, anti-drug antibodies, and assay validation.

All articles
Schematic figure illustrating: Degevma's FDA Approval and a Market with More Than 20 Denosumab Biosimilars: What Immunogenicity Comparability Testing Actually Requires

Degevma's FDA Approval and a Market with More Than 20 Denosumab Biosimilars: What Immunogenicity Comparability Testing Actually Requires

The FDA's approval of denosumab-adet (Degevma) on September 28, 2026 brings the cumulative total of approved denosumab products to at least 20, raising a concrete methodological question: in a market this saturated, with interchangeability-driven pharmacy substitutions, what does a reported ADA incidence figure actually tell you? The answer depends entirely on whether the assay has solved the soluble RANKL interference problem, and the published literature shows that not every program has.

Schematic figure illustrating: LBA vs. Intact LC/HRAM for ADC Quantification: What Each Method Actually Measures

LBA vs. Intact LC/HRAM for ADC Quantification: What Each Method Actually Measures

Selecting a bioanalytical platform for antibody-drug conjugates is a structural decision: deconjugation and DAR shift mean the circulating analyte changes continuously after dosing. Two 2026 publications, an AAPS ADC Working Group white paper and a peer-reviewed PPD hybrid assay validation, sharpen the practical framework for LBA, intact LC/HRAM, and hybrid LBA-LC-MS approaches in regulated ADC studies.

Schematic figure illustrating: Immunogenicity Assessment for LNP-Based Therapeutics: Mapping the Assay Demands Across Innate and Adaptive Endpoints

Immunogenicity Assessment for LNP-Based Therapeutics: Mapping the Assay Demands Across Innate and Adaptive Endpoints

LNP-based therapeutics generate immunogenicity signals across at least two immune layers, involving carrier and cargo independently, against a background of pre-existing anti-PEG antibodies in a substantial fraction of patients. No finalized LNP-specific immunogenicity guidance exists, leaving bioanalytical scientists to build assay strategies from the LNP-specific evidence base up. This article maps the cytokine, complement, anti-PEG, and cellular endpoints that a fit-for-purpose panel must address.

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