Immunogenicity refers to the ability of an antigen to induce an immune response. Proteins and antibodies, due to their structure and function, are often antigenic. This is particularly important for biotherapeutics as they are more likely to be recognized as foreign by the immune system, leading to the production of anti-drug antibodies (ADAs). SBH Sciences navigates the complexities of immunogenicity at all stages of the drug-discovery process by providing comprehensive immunogenicity testing services.
Our services include in-vitro models designed to predict the potential immunogenicity of proteins, antibodies, and other novel biologics, helping to anticipate how a new therapeutic may interact with the immune system. Additionally, we provide evaluation of immune response conducted in pre-clinical models as well as clinical samples to assess how the immune system responds to a particular therapeutic, which is critical in understanding the safety and efficacy of biologics before moving into clinical trials.
This assay measures human T-cell activation following exposure to a potential drug. For this assay SBH uses PBMC from StemExpress, isolating the T-cells through negative selection using STEMCELL EasyStep Human T-Cell Enrichment Kit. In addition to using T-cells isolated from PBMCs, SBH has also used Jurkat E6-1 cells.
Activation markers such as CD69, CD25, CD4, and CD8 are analyzed using multiple platforms, including ELISA, Luminex and flow cytometry. See the data below of T-Cell Activation by CD3 and CD23 antibodies.
SBH Sciences has the expertise to develop, qualify, and validate anti-drug antibody (ADA) methodologies. We have successfully developed ADA assays for several recombinant proteins, customized to our clients’ needs.
In addition to traditional ELISA-based assays, we offer advanced cell-based assays to detect neutralizing anti-drug antibodies (NAbs). We develop direct and indirect assays, optimizing them based on the mechanism of action of the drug and leveraging our experience with target-specific cell-based assays. Our testing services also include the detection of NAbs in patient serum or plasma samples.
To ensure the highest sensitivity and reproducibility, we optimize each assay to deliver reliable and precise results.
As the world’s leading provider of cytokine cell-based assays, with over 350 assays currently available, SBH Sciences offers the necessary tools for a rapid and effective project timeline.
Please contact us so we can discuss your specific needs and how we can support your immunogenicity goals.