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: 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.

Schematic figure illustrating: Four Analytes, One Plasma Sample: The Assay Science Behind Multi-Biomarker Alzheimer's Testing

Four Analytes, One Plasma Sample: The Assay Science Behind Multi-Biomarker Alzheimer's Testing

Four blood-based Alzheimer's disease biomarker tests were cleared by the FDA within fifteen months, and a five-analyte algorithmic panel is under 510(k) review. For immunoassay scientists deploying these panels, the analytical challenges of femtomolar sensitivity, cross-reactivity between tau isoforms, preanalytical instability of Aβ42, and cross-platform harmonization are the least-settled problems in making multi-biomarker results hold up outside a research cohort.

Schematic figure illustrating: CPS1 Serum Immunoassay: What a Mitochondrial Enzyme Biomarker Tells You That ALT Cannot

CPS1 Serum Immunoassay: What a Mitochondrial Enzyme Biomarker Tells You That ALT Cannot

Carbamoyl phosphate synthetase 1 (CPS1) is a hepatocyte-selective mitochondrial enzyme with a serum half-life of roughly 126 minutes, making it a near-real-time indicator of injury trajectory rather than injury presence. A 2026 Gut review synthesizes a decade of mechanistic and clinical work, including ELISA data from 764 serial samples across 270 acute liver failure patients, establishing CPS1 as a prognostically informative complement to standard aminotransferase panels. All AlpinaBioTech CPS1 immunoassay products are for Research Use Only.

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