European Pharmacopeia Regulatory Testing Requirement

21 day extraneous Bovine viruse assay for animal origin products using bovine primary cells in strict compliance with EMA/CHMP/BWP/457920/2012 rev.1,7.3.1,7.3.2,7.3.4,7.3.4, EMEA/CPMP/BWP/1793/02 (2003) 5.3.1, 5.3.2, 5.3.3; EMEA/CVMP/743/00 Rev.2 (2005) 4.3.3.1, 4.3.3.2; European Pharmacopeia 5.2.5 (01/2005:50205); Satisfies General Requirements for Viral Vaccines for Veterinary Use 7Blm1a and 7Blm2a; USDA-APHIS 9/CFR 113.53c (final testing by 113.46 and 113.47)

We offer a hybrid test for European Pharmacopeia Regulatory Testing that satisfies the CHMP/CPMP/CVMP and USDA/APHIS requirement. The base test is EP-1. This satisfies the CHMP7.3.1,7.3.2, CPMP 5.3.1, and CVMP 4.3.3.1 base requirements, and USDA/APHIS 113.53c requirement.

In addition to the base test, bovine serum must include testing for anti-BVDV antibody. This is a requirement for both CHMP, CPMP and CVMP requirement. We recommend that this is done using the ALPHA-SN for BVDV Genotype 1, and BVDV Genotype 2. These assays report the TCID50 of BVD1, and BVD2 neutralized by 1ml of serum.

All serum found positive for BVD virus must be quantified for the concentration of virus in the serum. Only serum containing < 10E6.0 TCID50/ml of BVD virus can be inactivated and acceptable for sale. To accomplish this, pre-inactivation serum must be checked for concentration, then post-inactivated serum must be checked to verify inactivation was complete. Serum must contain less than 10E6.0 combined concentration of virus and/or anti-BVDV neutralizing antibody to qualify for release.

CPMP no longer requires the Serum Inhibitory test by requirement. CVMP previusly removed this testing from the requirement. If your internal specifications still require this test it is still available.

EMA/CHMP/BWP/457920/2012 rev.1,EMEA/CPMP/BWP/1793/02, USDA/APHIS 113.53c, EMEA/CVMP/743/00-REV.2, USDA/APHIS 113.53c
Section -------------------Test ID----------------------Description
7.3.1,2,5.3.2, 4.3.3.1,------EP-1--------------------Base Virus assay
7.3.4,5.3.3,4.3.3.3-----ALPHA-BV1-----------anti-BVD 1 antibody assay
7.3.4,5.3.3,4.3.3.3-----ALPHA-BV2-----------anti-BVD 2 antibody assay
7.3.3,5.33,4.3.3.2--------QUANT---------------BVD Virus Quant assay
               Other Individually Available EMEA and Serological Testing

Test ID------------------------------------------------Description of Assay
ALPHA-SN-----------------Constant Serum/Reducing Titer Virus Serum Neutralization assay. Reports TCID50 of virus neutralized by 1ml of serum.
Beta-SN-------------------- Constant Virus/Reducing Titer Serum Neutralization assay. Reports dilution of serum required to neutralize 100 – 300 TCID50 of virus.
VT-SN---------------------- Reducing Virus/Reducing Serum Titer Serum Neutralization assay. Reports the Neutralization Index in Log10 of virus.
SI----------------------------Serum Inhibitory Test for BVD. Stand-alone assay no additional testing needed.
EP-SI------------------------Serum Inhibitory Test for BVD. Ran as addition after EP-1 assay.
QUANT-------------------- BVD virus quantification. Reports TCID50 of BVD virus in 1ml of serum.

All Regulatory Testing performed by protocols validated by OIE/ICH and Q5-A recommendation.