Monoclonal antibodies and next-generation molecules such as antibody-drug conjugates (ADC) are being developed and moved into early-phase clinical testing. In this study, we detect Pre-Existing Antibodies (PEXA) using a homogenous MesoScale assay.
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A patient may have pre-existing antibodies (PEXA) to a therapeutic, which can impact the immune response to the drug in question. In this paper, we discuss the nature of PEXAs, how they can be detected and characterized, and how sponsors should proceed when they are present.
In this white paper, we show testing of two critical parameters for the method validation of Gyrolab: 1) carryover contamination and 2) after MRD (minimum required dilution) stability.
Gene therapy holds the promise to transform medicine and creates options for patients who are living with incurable diseases. The industry has been booming in the last 20 years. Before a gene therapy product can be used in humans, the product must be tested for safety and effectiveness. This webinar focuses on the introduction of three critical test methods: AUC, Infectivity and RCL assays. Newly released FDA draft guidance for Industry on human gene therapy products will also be discussed.