Innate Immune Response Modulating Impurities Testing as a component of immunogenicity risk assessments
Daniela Verthelyi
Chief of the Immunology Lab in the Office of Pharmaceutical Quality Research, CDER, FDA
The talk will describe key concepts in the use of in vitro tools to assess potential differences in product and process related impurities of follow-on peptides, proteins, and oligonucleotides that may result in increased risk of product immunogenicity or reactogenicity. Specifically we will discuss strategies to ensure the assays are fit for purpose and approaches for data analysis using case studies.
Daniela Verthelyi, Ph.D., currently heads the Laboratory of Innate Immunity and the Center for Excellence in Infectious Diseases and Inflammation in CDER, FDA. She directs a lab focused on developing tools to monitor and control innate immune and inflammatory responses including potential impurities in therapeutic products that may foster unwanted immune responses therapeutic proteins reducing their life-saving potential. She has been a driving force in developing new strategies and tools to perform immunogenicity risk evaluation and mitigation for therapeutic proteins, peptides and oligonucleotides. She has chaired the FDA-NIH Immunology Interest Group, the NIH-FDA Cytokine Interest Group, and served on the Advisory Boards for the NIH Human Immunology Group and has contributed to writing multiple FDA Guidance for Industry documents related to immunogenicity. She has authored over 100 scientific papers, holds multiple patents, and has received FDA's, CBER’s, and CDER’s “Excellence in Laboratory Sciences” awards, among other honors.