Dr. Jeff Patrick answers questions on how BioAgilytix translated a diagnostic virus neutralization method to a quantitative relative potency assay for an anti-viral antibody.
On May 7, we'll be hosting webinar highlighting the importance of streamlining the time & cost of bioanalytical testing to support therapeutic development for viral infections such as COVID19 and influenza. We share a sneak peek of the content here.
We discuss the need to put phase-appropriate methods in place to identify and quantify both process- and host-cell related impurities throughout the drug development process.
In our blog discussing the use of cellular assays for neutralizing antibody (NAb) detection, we touched on the value that bioassays offer through their ability to closely mimic the effects that a biotherapeutic drug product will have on the body without the use of animals in the study. This is what makes cell-based potency assays the choice for measuring and validating the therapeutic activity of a drug product within prescribed ranges of safety, purity, and strength (potency), which is a requirement for regulatory submission and both clinical and commercial lot…
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