Cell-based assays for immunogenicity and immunotoxicity In vivo animal models are not necessarily predictive for immune responses in humans due to species differences. In vitro immunogenicity and …

This guidance provides recommendations to facilitate industry’s development and validation of assays for assessment of the immunogenicity of therapeutic protein products during clinical trials.

Here, we review factors associated with immunogenicity of biopharmaceuticals, potential clinical ramifications, and current regulatory guidance for evaluating immunogenicity, and discuss methods …

Apr 25, 2025 · This article delineates the principles of immunogenicity, its mechanisms, detection strategies aligned with FDA/EMA/NMPA immunogenicity guidance, and analytical challenges in ADA …

Cell-Based Assays are essential tools for evaluating immunogenicity, as they assess immune responses by detecting activation, proliferation, or secretion functions of specific cell populations.

The development of adequate screening and confirmatory assays to measure immune responses against a therapeutic protein is the basis of the evaluation of immunogenicity.

In this article, bioanalytical methods expert Dr. Ron Bowsher of Millipore Corporation describes the evolution of immunogenicity testing standards over the decade, culminating in the 2009 formal draft …

Watch the webinar to learn about immunogenicity testing at the early phase of drug development. Find out how it can play a crucial role in avoiding possible clinical consequences of unwanted immune …

Immunogenicity assays provide a way to measure the potential immune responses of biologics and biosimilars. Often a single biologic will require a panel of assays to produce a thorough picture of …

Immunogenicity testing is a crucial part of biopharmaceutical development. More stringent regulations regarding immunogenicity assay performance necessitates the development of assays exhibiting …