This review summarizes the viral safety concepts applied for cell line derived recombinants including biosimilars. The major aspects - material sourcing, testing, and viral clearance - are outlined and essentials per aspect to be considered described in more detail. The principles of viral clearance are explained in more detail like the background of viral removal or inactivation, model virus selection and definition of virus reduction capacity.
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| http://dx.doi.org/10.1016/j.ddtec.2020.08.001 | DOI Listing |
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