In addition to our laboratory services we assist our clients with consultations regarding viral safety, such as:
Viral risk assessment reports
Advice on viral reduction strategies
Advice on down-scaling strategies
Advice on regulatory requirements
Viral risk assessment reports
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.
Would you like to know if this applies to your biological substance?Contact us.
