Seed materials, including cell banks and raw serum for anti-serum production shall be tested for identity and adventitious agents.
Raw Serum Process
Animal blood is collected ... Whole fetal blood is aseptically collected via cardiac puncture and allowed to clot under controlled conditions. After centrifugation, the serum is decanted from the clot. The raw serum is then pooled and immediately frozen. Raw serum is pre-tested in advance of acceptance by JRH Biosciences according to established criteria, providing a complete awareness of all serum characteristics intended for direct human or therapeutic use.
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