Laboratory Considerations for Clinical Trials
Covid Vaccine Testing
In this episode, Dr. Robert Bailer, Senior Director for Vaccines at Q2 Solutions, describes the processes for testing vaccines against the novel coronavirus, SARS-CoV-2. He covers both ELISA and virus neutralization assays.
Q2 Solutions has developed an ELISA assay to evaluate multiple different antigens at the same time. Looking primarily at the spike protein, it is dissected into different parts: S1, S2, S1 plus S2, and the receptor binding domain. The nucleocapsid protein is being evaluated as well.
We are taking a 2 pronged approach to the viral neutralization assays, working in collaborations with academic institutions to deliver a cutting edge approach.
The first, in collaboration with the laboratory Dr. Pei-Yong Shi at the University of Texas Medical Branch in Galveston, involves viral-like particles (VLPs) where the structural genes of wild type SARS-CoV-2 virus are removed and replaced with a reporter gene. In this particular case, it's a GFP or green fluorescent protein gene along with a neomycin resistance gene.
The second approach is a SARS Co-V 2 surrogate neutralization assay used under a license agreement with the Albert Einstein College of Medicine. This is the vesicular stomatitis pseudovirion process, commonly used for viral neutralization assays. It’s a different way of expressing an artificial virus. It involves taking the vesicular stomatitis virus genome, replacing some of the genes for VSV by inserting the SARS-CoV-2 spike genes, plus a reporter gene. Expressing that produces a virus-like particle or a pseudovirion that can be utilized. This approach has been used over the years in a wide variety of different applications at Q2 Solutions for example in Ebola.
The vaccine operation at Q2 Solutions has the infrastructure, the capabilities and support to have a three shift operation. We anticipate doing this 24/7, which is exactly what’s needed in the context of a pandemic. Further, our center for vaccine excellence located in Beijing, China will evaluate clinical trial samples coming to us there with the same repertoire of assays that are available in San Juan Capistrano, California. The Q2 Solutions model is that we provide answers globally and with high throughput.
Learn more at Q2labsolutions.com.
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