ADA References

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 [...]

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 [...]

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 [...]

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a systematic search of four electronic databases through 6 January 2025, supplemented by trial registry searches for unpublished trials.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 [...]

Immunogenicity assessment is critical in the development of biotherapeutics. Conventionally, this evaluation has been facilitated by employing ligand binding assays (LBAs). However, the development of immunogenicity assays by LBA can present certain challenges in some cases, and alternative assay platforms can be advantageous. In this study, liquid chromatography with tandem mass spectrometry (LC-MS/MS) was employed [...]

The immunogenicity of therapeutic proteins remains a key challenge, leading to early and late-stage clinical failures, posing a significant hurdle in the development of safe and efficacious biopharmaceuticals. This review highlights the main categories of factors influencing the immune response-mediated impacts of biotherapeutics: 1) patient-related factors, 2) product-related factors, and 3) administration-related factors. It provides [...]

Ulcerative colitis (UC) and Crohn's disease (CD), pose a substantial burden, necessitating effective therapies. Etrolizumab, a unique monoclonal antibody targeting integrins, initially showed promise but was terminated due to lack of efficacy in PhIII studies. The immune responses elicited by patients towards etrolizumab make it a compelling subject for further in-depth investigation. This study delves [...]

All biotherapeutics have the potential to induce an immunogenic response and generate anti-drug antibodies (ADAs), especially when administered as multiple doses over prolonged periods. However, a clinically meaningful effect of ADAs can be difficult to identify to communicate the impact of immunogenicity on drug exposure, safety and efficacy outcomes in product labels in a way [...]

An immunogenicity risk assessment (IRA) is a relatively new expectation of health authorities that is increasingly incorporated into the drug development process across the pharmaceutical/biotech industry. The guiding principle for an IRA includes a comprehensive evaluation of product- and patient-related factors that may influence the immunogenic potential of a biotherapeutic drug and a potential action [...]

Peptides are gaining remarkable popularity in clinical diagnosis and treatment due to their high selectivity and minimal side effects. Over 11% of all new pharmaceutical chemical entities authorised by the FDA between 2016 and 2024 were synthetically manufactured peptides. A critical factor that can potentially limit the efficacy and safety of peptide-based therapeutics or biologics [...]