Immunogenicity assays measure a species specific antibody response to specific therapeutic macromolecules. TGA Sciences, Inc. specializes in the development and validation of immunogenicity immunoassays for the detection of anti-drug antibodies (ADAs) for a wide range of purposes from R&D and GLP animal studies to GLP human clinical trials and cGMP vaccine stability programs.
These types of assays can be qualitative for total antibody (titer) or can be used to evaluate changes in antibody responses during a clinical trial from each patients’ baseline. Various formats can be attempted during development and depending upon the clients access to therapeutic specific positive serum, assay appropriate references, etc. can be generated for use in the routine running of the assay and to measure assay performance.
Positive responses from sample evaluations typically then are again tested for specificity in either a competitive assay format or in a neutralization assay format. TGA Sciences, Inc. has been developing these very specific assays for their clients since 1998 and has undergone multiple FDA and EU inspections for this purpose. Please see the latest inspection reports under the Accreditations page of this website.