Description of Collaborative Activity: |
Accidental contamination represents a major risk associated with the use of cell-substrate derived biologicals, including vaccines and antibodies, for human use. The possibility for viral contamination exists in primary cultures and established cultures. Sometimes these cells are grown in serum containing fetal calf serum, which can develop into transmissible spongiform encephalopathy (TSE/BSE). This initiative aims to rigorously characterize and safety test these cell substrates. For TSE/BSE infectivity, the long incubation time requires testing over multiple years. An external committee recommended testing for at least 10 years to obtain the maximum information. |
