Even the strongest study design may encounter issues with sufficient clearance to reach the target safety expectations. We explore risk areas in executing viral clearance studies and how to avoid them in designing viral clearance studies. Learn how to troubleshoot insufficient clearance issues and manufacturing deviations that impact viral safety.
Viral clearance studies for nonenveloped viral vectors have been performed less frequently than those of enveloped viral vectors. For this reason, the virus inactivation steps and the model virus panel for clearance studies may not be as clear. Gain a better understanding of viral clearance studies for AAV vectors.
Despite careful testing of starting materials and in-process intermediates, a virus could enter the manufacturing process undetected. The studies detailed here involve scaling down individual process steps, and, for each step, spiking the virus into the specific process intermediate, performing the process step, and measuring the virus remaining.
Discover a simple yet powerful solution for executing your viral clearance studies safely, thoroughly, efficiently, and on your timelines. Free your teams and trust your project with an experienced team from Provise™ Clearance.
Provise Clearance Services from the BioReliance® portfolio deploys a team of highly trained and experienced process scientists and study directors on your behalf, to perform all your required process steps at their state-of-the-art facilities. While they handle all the work, you get full transparency, control, and insight into every aspect of the study. Learn more.
This website uses cookies to ensure you get the best experience on our website. Learn more
