Immunogenicity Assessment

Immunogenicity refers to the ability of an antigen to induce an immune response. Proteins and antibodies are likely to be antigenic.

SBH Sciences is offering in-vitro models to predict the potential immunogenicity of proteins, antibodies and other biologic. SBH Sciences has the expertise to develop and validate methods to study the immunogenicity of your novel compounds. This also includes evaluation of the immune response in preclinical models and clinical samples.

The assay is based on exposure of human T-cells to the potential drug and the measurement of T-cell activation (by ELISA, Luminex and FACS analysis of CD69, CD25, CD4 and CD8). We are using peripheral blood Leukopak [Stemexpress] and performing the enrichment of the T-Cells by negative selection using the STEMCELL EasySep Human T-Cell Enrichment Kit.

Alternative, we are testing the Jurkat E6-1 cells and stimulate them by anti-CD3 and anti-CD28.




Anti-Drug Antibodies (ADA)

SBH Sciences can develop, qualified and validate the Anti-Drug Antibodies (ADA) method. We have developed this method for several recombinant protein (one project is currently in phase III).

We also had been involved in Adeno-associated virus (AAV) project the measurement the background level of anti-AAV prior to key efficacy study.

In addition to the traditional ELISA-Based, we can develop cell-based assay to detect Neutralizing Anti-Drug Antibodies (NABs). We would determine the effect of the human serum on the assay and will test for the NABs in patient serum samples. We would optimize the assay to ensure high sensitivity and reproducibility.

SBH Sciences is the world's leading provider of cytokine cell-based assays currently with over 300 assays. This provide us the tools for a rapid and very effective project time-line.

Please contact us so we can discuss your specific needs, and ways in which SBH Sciences might be able to work with you. We will be happy to assist you. Our expertise is your competitive edge!