U.S. flag An official website of the United States government

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

U.S. Food and Drug Administration
  1. Home
  2. Science & Research
  3. About Science & Research at FDA
  4. The FDA Science Forum
  5. Development of cell-based assay to characterize product aggregate attributes associated with innate immune activation
  1. The FDA Science Forum

2021 FDA Science Forum

Development of cell-based assay to characterize product aggregate attributes associated with innate immune activation

Download the Poster (PDF; 1.58 MB)
Authors:
Poster Author(s)
Her, Cheng; Thacker Seth; Baker, Logan; Verthelyi, D.
Center:
Contributing Office
Center for Drug Evaluation and Research

Abstract

Poster Abstract

Biologics, whether recombinant, synthetic or naturally-derived have the potential to induce an immune response in the host that can impact on the safety and efficacy of the product. Assessing the immunogenicity risk of a product and the potential clinical consequences of the immune responses to the product is difficult but can help streamline clinical trials and hasten availability of therapeutic products. Many proteins and peptides form some level of aggregation at release or during storage. Product aggregation is considered a risk factor for product immunogenicity, partly because they can induce an inflammatory response at the site of inoculation that facilitates the induction of an immune response. However, the characteristics of the aggregates that make them more or less immunogenic remain unclear. Using a combination of biophysical analytics and innate immune response assays we explore the response induced by different types of peptides and aggregates in an effort to correlate aggregate type, size, and shape with innate immune activation in vitro. Results show that not all product aggregates increase the immunogenicity risk.

Poster Image
Preview image of the scientific poster. For more information, please refer to the abstract or download the PDF version of the poster.

Download the Poster (PDF; 1.58 MB)

Back to Top