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Anti-drug antibody (ADA) assays are an important element in the suite of bioanalytical methods required for assessment of the safety and efficacy of recombinant-protein therapeutics. As such, and following extensive optimization, there is an expectation that clinical ADA assays be fully validated for multiple performance parameters, including sensitivity, specificity, reagent stability, and robustness. Among critical [...]

AIMS: Immunogenicity testing is a key component of protein drug development, with ADA bridging assays recognized as the gold standard method. These assays employ labeled therapeutic drugs for capture and detection, with the substrate playing a critical role in generating a detectable signal to differentiate the presence of anti-drug antibodies (ADAs) from nonspecific binding. This [...]

Significant progress in the application of immune checkpoint blockade for the treatment of multiple types of cancers has been achieved, but its overall response rate and therapeutic efficacy remain unsatisfactory. To address these limitations, the identification of a combinational approach to enhance the therapeutic efficacy of immune checkpoint blockade is needed. The activation of cyclic [...]

INTRODUCTION: This systematic review and meta-analysis aimed to compare the efficacy, safety, and immunogenicity of biosimilars and reference biologics (adalimumab, etanercept, infliximab) in the treatment of ankylosing spondylitis (AS). METHODS: We conducted a systematic search of four electronic databases through 6 January 2025, supplemented by trial registry searches for unpublished trials. We included head-to-head randomized [...]