Magdalena Tary-Lehmann
Case Western Reserve University School of Medicine, USA
Title: Challenges and successes of measuring antigen-specific immune responses
Biography
Biography: Magdalena Tary-Lehmann
Abstract
Assessing immunogenicity is a challenge in the biopharmaceutical industry, as an increasing number of new drugs and vaccines aim to elicit a response from the cellular components of the immune system. Antigen specific responses for white blood cells such as T, B, NK and others, is of paramount importance throughout the drug/vaccine development cycle in both the preclinical and clinical phases. It is often the case that cell responses are studied based upon population levels that presume outcomes, but do not clearly enumerate the products individual cells have released. Lack of sensitivity in these assays can lead to misinterpretation of results. Therefore, it may be of key importance to employ an assay that produces high sensitivity based upon single cell responses. For this reason, assays such as ELISA and flow cytometry should be complemented with a single cell assay such as ELISPOT. Measurements of antibodies in bodily fluids (e.g., by ELISA) have provided robust and reproducible results for decades and such assays have been validated for monitoring of B cell immunity. While T cells play a critical role, reliable measurements of antigen specific T cell responses ex vivo remain seemingly problematic, as typically, T cells occur in very low frequencies in test samples, such as peripheral blood with the need to test live cells in functional assays ex vivo. Early considerations to the standardization of specimen processing, cryopreservation, sample management and assay systems are vital steps for the successful design and execution of pre-clinical and clinical trials that deliver consistent and regulatory acceptable immune monitoring data. Examples of such successful T cell monitoring in vaccine evaluations will be presented.