In addition to our laboratory services we assist our clients with consultations regarding viral safety, such as:
On a case-by-case basis, a biologically-derived product may not be classified by the Regulatory Agencies as a biological substance due to harsh treatments of the raw material. In this case, there is no requirement for viral clearance studies and a viral risk assessment report is accepted by the Regulatory Agencies in conjunction to your application. This report evaluates the virus inactivation efficiency of the production steps and provides an overall virus risk assessment based on literature data.
The Vironova Biosafety services team have a broad research background and experience of a wide range of biologics. We can help you to plan a specific study or solve a tricky problem. Whatever your need, you can contact Vironova Biosafety by sending an e-mail to firstname.lastname@example.org or by using the form on our contact us page.