Abstract

Immunotoxicity assessment in the realm of biopharmaceuticals is a critical endeavor, given their intricate mechanisms of action and potential to elicit unique immune responses. Traditional methods for evaluating immunotoxicity may not adequately capture the complexities associated with these innovative therapies. This article explores novel strategies that are emerging to address the challenges of immunotoxicity assessment in biopharmaceuticals. From in silico models to high-throughput screening, organ-on-a-chip systems, and biomarker identification, these approaches promise to enhance our understanding of immune reactions to biopharmaceuticals and contribute to safer drug development. Regulatory considerations play a pivotal role in the adoption of these strategies, ensuring their integration into the evolving landscape of biopharmaceutical evaluation.