Evaluating immunogenicity risk of complex peptide products

Generic peptide therapeutics enable the increased access to low cost and high-quality medicines. Current regulatory guidelines allow for the filing of highly purified synthetic generic peptides based on data from in vitro immunogenicity risk assessment and on the characterization of impurity profiles as compared with the approved reference drug. Here we highlight current methods for assessing both adaptive and innate immunogenicity risks as they have been adapted to support these filings.

Andrew earned his PhD in molecular biology from the University at Albany under the direction of Professor Robert Osuna, identifying and characterizing post translational modifications of the transcription factor DksA in E. coli. He joined ProImmune in 2019 after completing his doctorate and currently works on providing innovative solutions for clients that deeply improve our understanding of both desired and unwanted immune responses.