Mike Brown is the Senior Director of Immuno-analytical and the Bioanalytical Site Lead at IQVIA Laboratories. In this episode, he describes the considerations for pharmacokinetic and immunogenicity assays in the development of biologics. He lays out the types of analysis that are needed along with the associated challenges, such as detecting the concentration of a specific antibody therapeutic present at 100 picograms/ml in an antibody background of up to 20 billion picograms/ml. He suggests that sponsors think about the reagents that will be essential for the assays that need to be performed.
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