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. ABR has designed several validated assays to address these requirements.
| Materials to be Tested | Regulation Satisfied | Type of Assay | ABR Catalog Number | Required / Recommended Sample Size | Turn-Around Time (Days) |
| Bovine Serum | CVMP/743/00-Rev.2 (2005) 4.3.3.1, 4.3.3.2, CPMP/BWP/1793/02 (2003) 5.3.1, 5.3.2, 5.3.3, EP 5.2.5, 9/CFR 113.53c (including 113.46 & 113.47) | Virus Detection | EM-AOP-BOV | 80 mL 150 mL |
25-32 |
| Bovine Serum | CVMP/743/00 (4.3.3.3), CPMP/BWP/1793/02 (5.3.3) | Neutralizing Antibody Detection, Alpha SN | ALPHA-AOP-BOV | 2 mL 5 mL |
7-13 |
| Bovine Serum | CVMP/743/00 (4.3.3.3), CPMP/BWP/1793/02 (5.3.3) | Neutralizing Antibody Detection, Beta SN | SN-AOP-BOV-4 | 6 mL 10 mL |
7-13 |
| Bovine Serum | CPMP/BWP/1793/02 (2003) 5.3.4 | Virus Interference Detection | EMCT-AOP-BOV or CT-AOP-BOV | 18 mL 30 mL |
31-38 |
| Bovine Serum | CVMP/743/00 (4.3.3.2), CPMP/BWP/1793/02 (5.3.3) | Virus Quantitation | QUANT-AOP-BOV | 2 mL 5 mL |
7-13 |
| Powder With Bovine Components | EP 5.2.5, 9/CFR 113.53c (including 113.46 & 113.47) | Virus Detection | EM-AOP-BOV | 2.0 g 5.0 g |
25-32 |
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ABR is committed to staying involved with the latest EP/EMA regulations. We would be happy to offer direction concerning your particular situation and product. Please call us for more information.
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