Viral safety is a great concern when developing and producing a biological product, especially for those whose manufacture has involved the use of material of human and animal origin.
For such products, absence of viral contamination must be demonstrated according to current regulations since viral safety is required for clinical phase, marketing authorisation and Batch/Lot release.
Indeed, the risk of viral contamination is a feature common to all biotechnology product derived from cell substrates such as monoclonal antibodies and recombinant DNA-derived products as well as gene therapy products.
Moreover, cell substrates (e.g MCB) are not the only source of contamination as adventitious virus might be unintentionally introduced during production of biological medicines.
In this context, risk assessment and testing strategy are key elements to address this issue.
The aim of the webinar is to provide an overview of regulatory aspects of viral safety with a focus on risk assessment and testing; in particular:
-Requirements according to current regulation
-What to consider for risk assessment
-Recommended Virus Detection and Identification Assays