Erik Jerks
The pharmaceutical industry is in a race to treat and prevent COVID-19 from impacting more human lives. This has led to many alternative approaches, but regulated Bioanalytical is not an area where short cuts should be taken. We will discuss current approaches available for therapeutic and vaccine Bioanalytical assessments and regulatory requirements in clinical research.
As an alternative to the current gold standard of conventional virus neutralization tests, we will highlight a simple and rapid validated SARS-CoV-2 surrogate virus neutralization test (sVNT) that is amenable to high-throughput testing and/or fully automated by detecting total immunodominant neutralizing antibodies that can be rapidly conducted without requiring a biosafety level 3 containment.
Learning Objectives: