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: Fortrea Acquires Worldwide Clinical Trials' Bioanalytical Lab: What the $45 Million CRO Deal Means for Assay Scientists

Fortrea Acquires Worldwide Clinical Trials' Bioanalytical Lab: What the $45 Million CRO Deal Means for Assay Scientists

On September 2, 2026, Fortrea announced a $45 million all-cash acquisition of Worldwide Clinical Trials' Early Phase Services division, bringing a 60,000-square-foot GLP bioanalytical laboratory and a 200-bed GCP clinical pharmacology unit under one operational roof. For assay scientists running PK and immunogenicity programs, the deal changes the vendor map by eliminating inter-organization hand-offs between sample collection and bioanalytical processing. Broader CRO consolidation and pending FDA biosimilar guidance shifts make integrated bioanalytical infrastructure increasingly valuable for early-phase biologic programs.

Schematic figure illustrating: Adalimumab Biosimilar Switches in Pediatric IBD: What the Trough Level Drop Means for Your Monitoring Protocol

Adalimumab Biosimilar Switches in Pediatric IBD: What the Trough Level Drop Means for Your Monitoring Protocol

Two 2026 multicenter studies confirm that nonmedical adalimumab biosimilar switches in children with IBD generally maintain disease control, but trough levels fell significantly post-switch in one cohort, and neither study included systematic TDM or ADA testing. This article examines what that measurement gap means for laboratory monitoring protocols around pediatric biosimilar switches.

Schematic figure illustrating: When ADA Incidence Misleads: Interpreting Highly Sensitive Immunogenicity Assays in Biosimilar Programs

When ADA Incidence Misleads: Interpreting Highly Sensitive Immunogenicity Assays in Biosimilar Programs

A biosimilar immunogenicity report showing a 42 percent ADA rate against a reference biologic's labeled 6 percent is not automatically a safety signal. The number is shaped as much by assay sensitivity, drug tolerance, and platform architecture as by the patient's immune response. This article explains how to interpret highly sensitive ADA data in biosimilar programs and what clinical switching data reveal about the stakes of getting it wrong.

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