EMA & EP Virus Testing
Validated assays for detection of adventitious viruses and neutralizing antibodies in bovine serum and other bovine materials.
Several guidance documents from committees of the EMA (European Medicines Agency) as well as European Pharmacopeia (EP) monographs govern testing of bovine serum and bovine origin materials used in manufacture of both human and veterinary medicinal products. VMRD has designed several validated assays to address these requirements.
Validated assays for detection of adventitious viruses and neutralizing antibodies in bovine serum and other bovine materials.
Several guidance documents from committees of the EMA (European Medicines Agency) as well as European Pharmacopeia (EP) monographs govern testing of bovine serum and bovine origin materials used in manufacture of both human and veterinary medicinal products. VMRD has designed several validated assays to address these requirements.
Alpha Neutralization, Bovine Viruses
Assay Length:
7 days
Catalog Number:
ALPHA-AOP-BOV
Regulations Satisfied:
CVMP 4.3.3.3, CHMP 7.3.4
Volume Required:
5 mL
Materials Tested:
Serum
Viruses Detected by FA:
Antibodies to BVDV1 (cytopathic)
Optional Viruses Detected by FA:
NA
Alpha Neutralization, Porcine Viruses
Assay Length:
7 days
Catalog Number:
ALPHA-AOP-POR
Regulations Satisfied:
CVMP 4.3.3.3, CHMP 7.3.4
Volume Required:
5 mL
Materials Tested:
Serum
Viruses Detected by FA:
Antibodies to PPV
Optional Viruses Detected by FA:
NA
Stand Alone Comparative Titration/Serum Inhibition Test
Assay Length:
28 days
Catalog Number:
CT-AOP-BOV
Regulations Satisfied:
CPMP/BWP/1793/02 (2003) 5.3.4
Volume Required:
2 mL
Materials Tested:
Serum
Viruses Detected by FA:
BVDV
Optional Viruses Detected by FA:
NA
Bovine Virus Assay
Assay Length:
22 days
Catalog Number:
EM-AOP-BOV
Regulations Satisfied:
EP 5.2.5, CVMP 4/3/3/1,2, CHMP 7.3.1,2.3
Volume Required:
100 mL
Materials Tested:
Serum
Viruses Detected by FA:
BVDV, REO, RAB, BTV, BAV-3, BAV-5, BPV, BRSV, BLV, VSV
Optional Viruses Detected by FA:
FA-IBR, FA-PI3
Canine Virus Assay
Assay Length:
22 days
Catalog Number:
EM-AOP-CAN
Regulations Satisfied:
EP 5.2.5
Volume Required:
50 mL or 2 grams
Materials Tested:
Serum, Powder
Viruses Detected by FA:
-
Optional Viruses Detected by FA:
-
Equine Virus Assay
Assay Length:
22 days
Catalog Number:
EM-AOP-EQU
Regulations Satisfied:
EP 5.2.5
Volume Required:
50 mL or 2 grams
Materials Tested:
Serum
Viruses Detected by FA:
BVDV, REO, RAB, EHV, EAV
Optional Viruses Detected by FA:
FA-EIA
Feline Virus Assay
Assay Length:
22 days
Catalog Number:
EM-AOP-FEL
Regulations Satisfied:
EP 5.2.5
Volume Required:
50 mL or 2 grams
Materials Tested:
Serum
Viruses Detected by FA:
-
Optional Viruses Detected by FA:
-
Porcine Virus Assay
Assay Length:
22 days
Catalog Number:
EM-AOP-POR
Regulations Satisfied:
EP 5.2.5
Volume Required:
50 mL or 2 grams
Materials Tested:
Serum, Powder
Viruses Detected by FA:
BVDV, REO, RAB, PAV, PPV, TGE, PHEV
Optional Viruses Detected by FA:
FA-PCV1, FA-PCV2, FA-PIV, FA-PRCV, FA-PRV, FA-VSV
Vero Virus Assay of Animal Origin Product
Assay Length:
22 days
Catalog Number:
EM-AOP-VERO
Regulations Satisfied:
EP 5.2.5
Volume Required:
50 mL or 2 grams
Materials Tested:
Serum, Powder
Viruses Detected by FA:
BVDV, REO, RAB
Optional Viruses Detected by FA:
NA
Comparative Titration/Serum Inhibition Test
Assay Length:
28 days
Catalog Number:
EMCT-AOP-BOV
Regulations Satisfied:
CPMP/BWP/1793/02 (2003) 5.3.4
Volume Required:
2 mL
Materials Tested:
Serum
Viruses Detected by FA:
BVDV
Optional Viruses Detected by FA:
NA
Modified Bovine Virus Assay (virus specific)
Assay Length:
22 days
Catalog Number:
MEM-AOP-BOV
Regulations Satisfied:
Partial EP 5.2.5, CVMP 4.4.4.1,2, CHMP 7.3
Volume Required:
50 mL
Materials Tested:
Serum
Viruses Detected by FA:
Any of Optional Add-Ons
Optional Viruses Detected by FA:
FA-BVD, FA-REO, FA-RAB, FA-PAV, FA-PPV, FA-TGE, PHEV, FA-PCV1, FA-PCV2, FA-PIV, FA-PRCV, FA-PRV, FA-VSV
Modified Canine Virus Assay (virus specific)
Assay Length:
22 days
Catalog Number:
MEM-AOP-CAN
Regulations Satisfied:
Partial EP 5.2.5
Volume Required:
50 mL or 2 grams
Materials Tested:
Serum
Viruses Detected by FA:
Any of Optional Add-Ons
Optional Viruses Detected by FA:
FA-BVD, FA-REO, FA-RAB, FA-PAV, FA-PPV, FA-TGE, PHEV, FA-PCV1, FA-PCV2, FA-PIV, FA-PRCV, FA-PRV, FA-VSV
Modified Equine Virus Assay (virus specific)
Assay Length:
22 days
Catalog Number:
MEM-AOP-EQU
Regulations Satisfied:
Partial EP 5.2.5
Volume Required:
50 mL or 2 grams
Materials Tested:
Serum
Viruses Detected by FA:
Any of Optional Add-Ons
Optional Viruses Detected by FA:
FA-BVD, FA-REO, FA-RAB, FA-PAV, FA-PPV, FA-TGE, PHEV, FA-PCV1, FA-PCV2, FA-PIV, FA-PRCV, FA-PRV, FA-VSV
Modified Feline Virus Assay (virus specific)
Assay Length:
22 days
Catalog Number:
MEM-AOP-FEL
Regulations Satisfied:
Partial EP 5.2.5
Volume Required:
50 mL or 2 grams
Materials Tested:
Serum
Viruses Detected by FA:
Any of Optional Add-Ons
Optional Viruses Detected by FA:
FA-BVD, FA-REO, FA-RAB, FA-PAV, FA-PPV, FA-TGE, PHEV, FA-PCV1, FA-PCV2, FA-PIV, FA-PRCV, FA-PRV, FA-VSV
Modified Porcine Virus Assay (virus specific)
Assay Length:
22 days
Catalog Number:
MEM-AOP-POR
Regulations Satisfied:
Partial EP 5.2.5
Volume Required:
50 mL or 2 grams
Materials Tested:
Serum, Powder
Viruses Detected by FA:
Any of Optional Add-Ons
Optional Viruses Detected by FA:
FA-BVD, FA-REO, FA-RAB, FA-PAV, FA-PPV, FA-TGE, PHEV, FA-PCV1, FA-PCV2, FA-PIV, FA-PRCV, FA-PRV, FA-VSV
Sample Ultracentrifugation & BVD Quantification
Assay Length:
7 days
Catalog Number:
QUANT-AOP-BOV
Regulations Satisfied:
CVMP 4.3.3.3, CHMP 7.3.4
Volume Required:
35 mL
Materials Tested:
Serum
Viruses Detected by FA:
NA
Optional Viruses Detected by FA:
NA
Sample Ultracentrifugation & PPV Quantitation
Assay Length:
7 days
Catalog Number:
QUANT-AOP-POR
Regulations Satisfied:
NA
Volume Required:
25 mL or 1 gram
Materials Tested:
Serum, Powder
Viruses Detected by FA:
PPV
Optional Viruses Detected by FA:
NA
Serum Neutralization, Bovine Viruses
Assay Length:
7 days
Catalog Number:
SN-AOP-BOV
Regulations Satisfied:
CVMP 4.3.3.3, CHMP 7.3.4
Volume Required:
5 mL
Materials Tested:
Serum
Viruses Detected by FA:
Antibody neutralization of specified bovine virus
Optional Viruses Detected by FA:
BVD1, BVD2, IBR, PI-3, BRSV
Serum Neutralization Assay, Porcine Viruses
Assay Length:
7 days
Catalog Number:
SN-AOP-POR
Regulations Satisfied:
CVMP 4.3.3.3, CHMP 7.3.4
Volume Required:
5 mL
Materials Tested:
Serum
Viruses Detected by FA:
Antibody neutralization of specified porcine viruses
Optional Viruses Detected by FA:
PPV
Virus Reduction - Serum Neutralization Assay
Assay Length:
7 days
Catalog Number:
VR-AOP-BOV
Regulations Satisfied:
NA
Volume Required:
5 mL
Materials Tested:
Serum
Viruses Detected by FA:
Antibody neutralization of BVDV
Optional Viruses Detected by FA:
NA