AlpinaBioTech Digest - July 2026

This month's articles cover three areas with direct implications for laboratories running immunogenicity and therapeutic drug monitoring assays. All content is published for Research Use Only.

The most technically detailed piece addresses a specific and consequential interference problem in anti-drug antibody bridging assays for denosumab biosimilars. Standard acid dissociation pretreatment, when applied in this context, can drive false-positive ADA rates as high as 96 to 98%, a consequence of soluble RANKL accumulation following dosing. The article describes how adding osteoprotegerin as a specificity tier brings observed false-positive incidence down to 3.9% or below, and reviews supporting immunogenicity data from ten FDA-approved biosimilar programs. Alongside that, a narrative review from Bioanalysis proposes a closed-loop, AI-augmented framework for immunogenicity assessment that connects known assay failure points, including gaps between ADA measurement and clinical prediction, to real-world evidence feedback and emerging deep learning tools for epitope prediction and pharmacovigilance.

The third article covers the business development news with the most near-term operational relevance for assay scientists: Merck KGaA's agreement to acquire Bio-Techne for US$11.3 billion. Because the deal places R&D Systems, Ella/Simple Plex, and a large catalog of immunoassay reagents under new ownership ahead of an anticipated close in late 2026 or early 2027, scientists running validated ELISA, multiplexed, and TDM workflows should review their current lot documentation and monitor catalog changes now rather than after the transition.