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.
Featured ELISA kits
Drug-level and anti-drug antibody assays across TNF-alpha, VEGF, EGFR, HER2, and more.
ADALIMUMAB ELISA
Analyte: Adalimumab
View kitADALIMUMAB ELISA (MAB-BASED)
Analyte: Adalimumab
View kitAFLIBERCEPT ELISA
Analyte: Aflibercept
View kitANTIBODY TO ADALIMUMAB ELISA
Analyte: Adalimumab
View kitANTIBODY TO BEVACIZUMAB ELISA
Analyte: Bevacizumab
View kitANTIBODY TO CERTOLIZUMAB PEGOL ELISA
Analyte: Certolizumab Pegol
View kitFrom our journal
Background on ELISA methods, therapeutic drug monitoring, anti-drug antibodies, and assay validation.
Pembrolizumab Biosimilars Are Entering Clinical Review: What the PK-Only Pathway Means for Immunogenicity Assay Scientists
The FDA accepted the first publicly announced pembrolizumab biosimilar BLA for review in October 2026, using a pharmacokinetic-only pivotal strategy that skips a comparative Phase 3 efficacy trial. For immunogenicity assay scientists, this regulatory pivot reframes how ADA comparability must be designed, validated, and interpreted in a drug class with low but clinically consequential reference product immunogenicity.
When PK and ADA Assays Become the Whole Argument: Biosimilar Regulatory Reform and What It Demands from Bioanalytical Scientists
Regulatory agencies in the US, EU, and Canada moved in 2025 and 2026 to reduce or eliminate comparative efficacy studies for biosimilar approval, placing pharmacokinetic and anti-drug antibody assays at the center of the evidentiary dossier. This article examines the three converging guidance documents, the validation demands they create, and the platform-level design principles scientists need to build biosimilar bioanalytical programs that can carry that evidentiary weight.
Vaccine Immunogenicity LBAs Have No Dedicated Validation Guidance: A Three-Part WRIB Series Sets Out to Change That
Ligand binding assays are the primary quantitative tool for vaccine immunogenicity studies, yet no dedicated regulatory framework has governed their development, validation, or lifecycle management. A three-part WRIB white paper series, now fully published in Bioanalysis, provides the first consensus-based guidance covering all three domains specifically for vaccine immunogenicity LBAs.