Species-Specific Assays

Species specific assays are applied on a risk based approach. All manufactured biologics should have an associated virus risk assessment which reviews the entire production process and highlights where viruses could enter the process. Some risks are more readily identified such as the use of bovine serum which may be contaminated with bovine viruses, the main risk however would be from the production cells themselves.

Antibody Production Tests

Species specific viruses present in rodent cell lines may be detected by inoculating test article into virus-free animals, and examining the serum antibody level or enzyme activity after a specified period. Examples of such tests are the Mouse Antibody Production (MAP) test, Hamster Antibody Production test (HAP) and Rat Antibody Production test (RAP). The viruses detected in the MAP test include; Ectromelia Virus; Lymphocytic Choriomeningitis virus, Hantaan Virus, Pneumonia Virus of Mice (PVM), Reovirus Type 3, Mouse Theilers Encephalomyelitis Virus, Lactic Dehydrogenase Virus, Sendai Virus, Minute Virus of Mice (MVM), Mouse Adenovirus, Mouse Cytomegalovirus, Mouse Hepatitis Virus, Mouse Rotavirus, Polyoma Virus, Thymic Virus and K virus. Viruses detected in the HAP test include; Lymphocytic Choriomeningitis virus (LCMV), Hantaan Virus, Pneumonia Virus of Mice (PVM), Reovirus Type 3, Sendai Virus and Simian virus type 5.

Polymerase Chain Reaction (PCR)

BioOutsource recognises the importance of sensitive and specific assays to detect virus contamination and has identified a number of viral risks for specific species types – Human, Simian, Bovine, Porcine, Avian and Rodent. Our scientists are also able to develop specific tests to order so please contact us if you have any custom assay requirements.

Assay Package Viruses Detected

Assay Package Viruses Detected
Human HIV/SIV types 1 and 2, HTLV types 1 and 2, Hepatitis virus types A, B and C, Human Herpes Virus types 6, 7 and 8, CMV, VZV, EBV, SV40, Parvovirus B19, SRV-1 and 2, Simian Foamy Virus, Human Papilloma types 16 and 18, Human Polyomavirus JC and BK, Enterovirus, Rubella
Simian Simian Virus 40 (SV40), Simian Foamy Virus (SFV), Simian Immunodeficiency Virus (SIV), Simian Retrovirus (SRV), Simian T cell lymphotropic Virus (STLV)
Bovine Blue Tongue Virus, Bovine Adenovirus, Bovine Adenovirus Type 3, Bovine Parvovirus, Bovine respiratory syncytial virus, Reovirus, Rabies virus, Bovine viral diahorrea virus, Bovine Polyoma virus, Bovine Circovirus, Bovine Parainfluenza virus type 3, Bovine Herpes virus Type 1
Porcine Porcine Adenovirus, Porcine Parvovirus, TGV, Haemagglutinating encephalomyelitis virus, Porcine circovirus
Avian Avian leukosis virus type J, Avian nephritis virus, Avian rotavirus, Reticuloendothelial virus (REV), Chicken anaemia virus (CAV), Newcastle disease virus (NDV)
Rabbit Rabbit kidney vacuolating virus, Rabbit haemorrhagic disease virus (RHDV), Shope fibroma virus, Rabbit oral papilloma virus, Borna disease virus, Adeno associated virus (AAV)
Insect Boolarra virus, Pariacato virus, Flock House virus, Nodamura virus

 

Contact us to discuss your species specific assay requirements.

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