The use of proteins, antibodies and Fc-fusion proteins to address clinical needs such as targeted treatments and treatment longevity has been a major success story in biotherapeutics. But with all great new leaps forward come new challenges. In order to address the safety of these newer biotherapeutics the FDA and other regulatory bodies require immunogenicity assessment as part of the submission packet.
Getting the immunogenicity program right is critical. AIT Bioscience has experience with both plate and cell-based antidrug antibody (ADA) and neutraling antibody (nAb) detection. We also understand the challenges and intricacies of identifying the source domain of immune response in higher complexity biotherapeutics such as fusion proteins. Learn more about how AITB was able to partner for success with a biotherapeutic client whose FDA response to its original ADA work had halted its clinical studies. See how AITB’s expertise helped the client get its studies back on the right track in our case study, “Addressing the Complexities of Working with a Fusion Protein.”