Tests For Extraneous Agents In Viral Vaccines For Human

In those tests that require prior neutralisation of the virus, use specific antibodies of non-human, non-simian origin; if the virus has been propagated in avian tissues, the antibodies must also be of non-avian origin. To prepare antiserum, use an immunising antigen produced in cell culture from a species different from that used for the production of the vaccine and free from extraneous agents. Where the use of SPF eggs is prescribed, the eggs are obtained from a flock free from specified pathogens (5.2.2).

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