Associate Director-Protein Therapeutics in Research and Development EpiVax, Inc. Providence, Rhode Island
Presentation Description: Recent evaluation of the immunogenicity of Salmon Calcitonin and synthesis-related impurities revealed several factors can impact immunogenicity assays. SCT, promotes calcium reabsorption and is used to treat Paget’s disease, shares only 50% sequence homology with Human Calcitonin leads to anti-drug antibodies in 40-70% of patients. T cell assays evaluating synthetic SCT and the SCT drug product Miacalcin® revealed that components of the drug product formulation may impact the results of T cell studies: 40% of donors responded to synthetic SCT, whereas only 10% responded to Miacalcin®. Miacalcin® contains acetic acid, which is known to impact energy metabolism in cell culture and could be causing the unexpectedly low response rate in T cell assays. Additionally, we provide an example in which immunogenic impurities did not increase the immunogenicity of a foreign peptide. Several factors are involved in the immunogenicity of synthetic peptide drugs and must be considered when designing immunogenicity studies.
understand the contribution of peptide sequence and formulation to immunogenicity
understand key considerations important to the design of immunogenicity screening assays
understand the contribution of peptide impurities to product immunogenicity