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: Rituximab Biosimilars in AAV: What Six-Month Real-World Data Tell Monitoring Scientists

Rituximab Biosimilars in AAV: What Six-Month Real-World Data Tell Monitoring Scientists

The BRAVO multicenter cohort study found no statistically significant differences in remission rates, relapse rates, or serious adverse events between biosimilar and originator rituximab at six months in granulomatosis with polyangiitis and microscopic polyangiitis. For laboratories supporting drug-level and immunogenicity testing in biosimilar-treated AAV populations, the findings reinforce rather than reduce the case for structured pharmacokinetic and pharmacodynamic monitoring. B cell depletion kinetics, ANCA serology, serum drug levels, and anti-drug antibody assays each remain indispensable endpoints regardless of which rituximab formulation the patient receives.

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.

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