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: Platform Choice at the Core of ADC Bioanalysis: What the Gyrolab-vs-Plate Debate Actually Requires Scientists to Decide

Platform Choice at the Core of ADC Bioanalysis: What the Gyrolab-vs-Plate Debate Actually Requires Scientists to Decide

Selecting between Gyrolab microfluidic and conventional plate-based immunoassay platforms for antibody-drug conjugate bioanalysis is not a single decision but a structured one made analyte by analyte. A sponsored interview published October 13, 2026, on Bioanalysis Zone, combined with the July 2026 AAPS ADC Working Group white paper in AAPS Journal, provides the clearest current framework for making those choices across total antibody, conjugated antibody, free payload, and immunogenicity assays. All assay content discussed is for Research Use Only.

Schematic figure illustrating: When PK Studies Slim Down, Immunogenicity Assays Carry More Weight: What FDA's 2026 Biosimilar Guidance Means for Bioanalytical Scientists

When PK Studies Slim Down, Immunogenicity Assays Carry More Weight: What FDA's 2026 Biosimilar Guidance Means for Bioanalytical Scientists

FDA's March 2026 draft guidance removes the default requirement for comparative PK bridging studies in biosimilar development, building on a prior October 2025 draft that proposed eliminating routine efficacy trials. Both actions shift evidentiary weight onto immunogenicity assays, raising the bar for ADA assay design, drug tolerance, and neutralizing antibody assessment before any clinical samples are collected.

Schematic figure illustrating: When ADA Positivity Is Not the Answer: Rethinking the Three-Tier Immunogenicity Paradigm

When ADA Positivity Is Not the Answer: Rethinking the Three-Tier Immunogenicity Paradigm

The standard three-tier ADA testing paradigm has governed biologic immunogenicity assessment for more than two decades, but a growing body of evidence questions whether it consistently delivers clinically meaningful data. New publications from Immunologix Laboratories, the European Bioanalysis Forum, and IQVIA Laboratories converge on a fit-for-purpose, context-of-use-driven alternative that treats immunogenicity as a continuous biomarker endpoint rather than a binary classification.

Need a specific assay or a quote?

Request a quote