This article explores why immunogenicity testing matters, the limitations of current approaches, and how ex vivo human skin models are reshaping this field. Why is assessing drug immunogenicity key ...

Novo Nordisk petitions the FDA to exclude liraglutide from the 503B Bulks List, citing safety risks, lack of clinical need, ...

Assessment of immunogenicity is an important component of drug safety evaluation in preclinical, clinical and postmarketing studies. Biopharmaceuticals currently employed in the clinic exhibit ...

In September 2007, the EMEA organized a workshop on immunogenicity assessment, giving various stakeholders the opportunity to comment and critically discuss the European draft guideline 3.

The safety, immunogenicity and optimal dosing regimen ... the placebo-controlled and randomized double-blind study. The 140 ...

This study should encourage labs to explore the use of multiplexing immunogenicity assays to characterize anti-drug antibody responses quickly, with less repeat testing and reduced sample handling.

Robust and comparable immunogenicity was observed between adolescents and young adults who received 2- or 3-dose schedules of ...

Immunogenicity was assessed by hemagglutination-inhibition (HI) prevaccination and 28 days after each vaccination. Immunogenic non-inferiority QIV versus TIV for shared strains, and superiority ...

Immunogenicity bioanalysis follows an industry-standard tiered-testing approach, including assay screening (all samples), ...