History of Virus Contamination Due to Raw Materialsa
| Raw Material | Contaminating Virus |
|---|---|
| Serum (bovine) | COMMON: Bovine viral diarrhea virus (37) and BVDV RNA (38, 39) |
| RARE: REO virus (40); Cache Valley virus (40); epizootic haemorrhagic disease virus (41, 42) | |
| Trypsin (porcine) | Porcine parvovirus (43); Porcine circovirusb (14) |
| Media components (suspected) | Minute virus of mice (44) |
| Cell substrates | Avian leukosis virus (embryonated hens eggs) (6), SV-40 (primary rhesus monkey kidney cell cultures) (7, 8), endogenous retrovirus particles (chicken cell cultures [5] and rodent cell linesc [1]); TNCL Alphanodavirus (Trichoplusia ni–insect cell line Tn5) (20) |
| Human blood and blood derivatives components (10–12, 45) | COMMON: Hepatitis B virus, Hepatitis delta virus, Hepatitis C virus, HIV, HTLV |
| RARE: West Nile virus, Human parvovirus B19, Human herpesviruses (CMV, EBV, HSV); Hepatitis A virus |
↵a Reported in human products or in cell substrates used in manufacture of human products.
↵b Reported while manuscript was in preparation.
↵c Monoclonal antibodies and therapeutic cytokines and growth factors, which use murine hybridoma cells and CHO cells, respectively, for therapeutic indications were transferred to CDER in 2003.