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: Atypical Carry-Over in a Gyrolab ADA Assay: Lessons from a Rituximab Biosimilar Case Study

Atypical Carry-Over in a Gyrolab ADA Assay: Lessons from a Rituximab Biosimilar Case Study

A published case study targeting MabionCD20, a rituximab biosimilar, identified wave-like signal fluctuations in Gyrolab-based ADA assays caused by neutralization buffer chemistry and fluorophore-induced isoelectric point shifts. The investigation offers transferable troubleshooting principles for any laboratory running Gyrolab-based immunogenicity programs, particularly around drug tolerance and repeatability.

Schematic figure illustrating: What "Highly Similar" Actually Requires: Analytical Methods for mAb Biosimilar Characterization

What "Highly Similar" Actually Requires: Analytical Methods for mAb Biosimilar Characterization

Regulatory approval of mAb biosimilars now depends less on replicating clinical trial results and more on high-resolution analytical characterization. A 2026 BioDrugs review of successful US and EU dossiers maps the assay strategies that matter, while the FDA's September 2025 waiver of a clinical efficacy study for a ustekinumab biosimilar makes the principle concrete for immunoassay and TDM scientists.

Schematic figure illustrating: Measuring the Pathogen, Not the Host: A High-Sensitivity ESAT-6 Blood Assay Distinguishes Active TB Across the Infection Spectrum

Measuring the Pathogen, Not the Host: A High-Sensitivity ESAT-6 Blood Assay Distinguishes Active TB Across the Infection Spectrum

A high-sensitivity biosensor for circulating ESAT-6 protein, a direct secretory product of Mycobacterium tuberculosis, produced a stepwise quantitative signal across the full TB infection spectrum in a 217-patient cohort presented at ADLM 2026. Unlike IGRAs, which measure host immune response, this antigen-direct approach distinguished active disease from latent infection and uninfected contacts with an AUC of 0.976, as reported in conference coverage pending peer-reviewed publication. Full analytical validation and prospective clinical data remain outstanding.

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