EMA and 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.

 

Materials Tested

Serum

Supplements

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Available tests - All Species

Catalog ID
ALPHA-AOP-BOV
Materials Tested
Serum
Regulations Satisfied
CVMP 4.3.3.3; CHMP 7.3.4
Samples
Needed
2 ml
Turn-Around
Time (Days)
7-14
ALPHA-AOP-BOVQualitative SN assay performed with dilutions of virus and a constant volume of serum with the result expressed as the amount of BVDV1 in (TCID50) neutralized by 1 ml test serum"
Catalog ID
EM-AOP-POR
Materials Tested
Serum
Regulations Satisfied
EP 5.2.5
Samples
Needed
80
Turn-Around
Time (Days)
25-32
EM-AOP-PORPorcine Virus Assay of equine origin product on a vero and porcine cells in compliance with European Pharmacopeia (EP) specifications
Catalog ID
EM-AOP-BOV
Materials Tested
Serum
Regulations Satisfied
EP 5.2.5; CVMP 4.3.3.1,2; CHMP 7.3.1,2,3
Samples
Needed
80 ml
Turn-Around
Time (Days)
25-32
EM-AOP-BOVBovine Virus Assay of bovine origin product on a vero and primary bovine cells in compliance with European Pharmacopeia (EP) and European Medicines Agency (EMA) Specifications including CVMP and CHMP
Catalog ID
EMCT-AOP-BOV
Materials Tested
Serum
Regulations Satisfied
EMA CPMP 5.3.4
Samples
Needed
2 ml
Turn-Around
Time (Days)
31-38
EMCT-AOP-BOVSerum inhibitory test as a regulatory compliance method that grows cells permissive for BVDV for at least 3 subcultures in the presence of test serum and then uses the cells to titrate a reference strain of BVDV
Catalog ID
MEM-AOP-BOV
Materials Tested
Serum
Regulations Satisfied
Partially compliant with EP 5.2.5; CVMP 4.3.3.1,2; CHMP 7.3.
Samples
Needed
80 ml
Turn-Around
Time (Days)
25-32
MEM-AOP-BOVVirus Assay of bovine origin product for a specific virus by FA on primary bovine cells using methods specified by European Pharmacopeia (EP) and European Medicines Agency (EMA) regulations including CVMP and CHMP
Catalog ID
QUANT-AOP-BOV
Materials Tested
Serum
Regulations Satisfied
CVMP 4.3.3.2, CHMP 7.3.3
Samples
Needed
25
Turn-Around
Time (Days)
7-13
QUANT-AOP-BOV7 day assay to ultracentrifuge and quantitate BVD virus in serum as required by CVMP 4.3.3.2 and CHMP 7.3.3
Catalog ID
SN-AOP-BOV-2
Materials Tested
Serum
Regulations Satisfied
CVMP 4.3.3.3 CHMP 7.3.4
Samples
Needed
2 ml
Turn-Around
Time (Days)
7-13
SN-AOP-BOV-2Beta SN (constant virus and dilutions of serum) to measure serumĀ  neutralization of the test material on two bovine viruses (BVDV-1 & BVDV-2) per CVMP 4.3.3.3 and CHMP 7.3.4, with the result expressed as dilution factor (e.g. 1:2)
Catalog ID
VR-AOP-BOV
Materials Tested
Serum
Regulations Satisfied
NA
Samples
Needed
1 ml
Turn-Around
Time (Days)
7-13
VR-AOP-BOVAssay to determine if a TA neutralizes BVD virus by mixing TA and virus and then titrating the amount of remaining virus (virus reduction)

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