ABR performs regulatory compliance testing for adventitious viruses in animal origin products, virus seeds and cell stocks used in the pharmaceutical and biotechnology industries.
- Assays for detection of adventitious viruses as specified in USDA-APHIS 9 CFR § 113.52, § 113.53c or § 113.55, including § 113.46 and § 113.47. ABR tests for all viruses and species listed in 9 CFR § 113.47. For testing on other origin species or other viruses, please inquire.
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EMA Compliant assays for Bovine and other viruses. ABR’s EMA assays satisfy European specifications as defined in:
- EMA/CVMP/743/00-Rev.2 (2005) 4.3.3.1, 4.3.3.2
- EMA/CPMP/BWP/1793/02 (2003) 5.3.1, 5.3.2, 5.3.3
- European Pharmacopoeia 5.2.5 (01/2005:50205)
- General Requirements for Inactivated (7Blm2a) and Live (7Blm1a) Vaccines for Veterinary use
- Modified EMA and 9 CFR procedure assays for Bovine, Canine, Equine, Feline, Lapine, Murine, and Porcine Viruses.
- Serology, including IFA, alpha SNs (serum neutralizations) and beta SNs
- Virus screening assays for common viruses like BVDV
- Custom testing: ABR offers a variety of custom tests. Please feel free to contact us to discuss your testing needs so that we can design a custom study that will meet your requirement.
Extended assay descriptions can be read here
or downloaded here.
Materials Tested:
Animal Origin Products
Cell Lines
Virus Seeds
Vaccines
Testing times vary by test.
Please call us for more information, or read some of our Frequently Asked Questions.
Don’t see what you’re looking for? We also offer custom testing!
