Analytical characterization of complex modalities like viral vectors is a significant challenge. For example, viral vectors can be unstable, which can make production difficult. Scientists are increasingly using viral vectors in clinical trials to evaluate gene therapies, oncolytic therapies, and vaccine applications.
Developing safe and efficacious therapies requires reliable analytics. Adenovirus (AdV) and adeno-associated virus (AAV) are two of the most widely used vector systems in clinical trials. For each process step, scientists need to analyze total virus particles, virus genomes, and virus functionality, as well as host cell protein and DNA impurities. Analyzing product quality attributes in the production process can be time-consuming and costly, and it can be difficult to make assays robust and reproducible. The current assays for viral vectors don’t have detection limits low enough for harvest samples. Additionally, the sample matrix can often affect results, and accuracy can depend on the sample’s impurity level.
This presentation describes reproducible and straightforward SPR assays for accurate and efficient Adv and AAV titer analysis using Biacore™ SPR systems. Our Biacore™ assays show strong correlation to existing techniques, but with higher repeatability, significantly reduced hands-on time, and a high degree of automation. Scientists can apply these rapid and reproducible assays in applications from development to quality control.
SPR can have a large impact in later stages of drug development. It’s a sustainable platform that scientists can use from research to FDA-approval for all biologics. With reusable sensor chips and low sample and reagent consumption, SPR can help improve process economy. To show how scientists are successfully applying the technology, I will also share an overview of industry case studies using SPR assays for QC.