Regulatory compliance testing for adventitious agents in virus seeds of various species to follow 9CFR guidance. These materials may be used in research or final products.
9CFR VIRUS TESTING
These assays evaluate the test articles for extraneous viruses as specified in USDA-APHIS 9 CFR 113.52, 113.53c, 113.55, including compliance with 113.46 and 113.47. VMRD tests for viruses in materials from all mammalian species listed in UDSA-APHIS 9 CFR 113.47.VIEW AVAILABLE TESTS
VMRD offers Bacteria and Fungi testing methods to satisfy USDA-APHIS 9CFR 113.26 for Animal Origin Products. Assay meets 113.25 requirements.VIEW AVAILABLE TESTS
VMRD offers mycoplasma assays to satisfy various regulations, including: USDA-APHIS 9CFR (9CFR 113.53a and 113.28) European Pharmacopeia (EP), European Medicinal Agency (EMA) (EP 2.6.7, EMA) United States Pharmacopeia (USP <63>)VIEW AVAILABLE TESTS
Bovine Polyomavirus (BPyV) Testing
VMRD’s validated 21 day assay for the detection of infectious BPyV is based on growth in bovine cells followed by an IFA detection of infective BPyV using a mono-specific antiserum generated against a BPyV subunit protein.This assay can reliably detect as little as 10-7 MOI (0.2 virions) in test articles.VIEW AVAILABLE TESTS
Senecavirus A (SVA) Testing
VMRD’s 22-day assay for the detection of infectious Senecavirus is based on growth in porcine cells followed by an IFA detection of infective Senecavirus A using a mono-specific antibody. This assay can reliably detect as little as 1 TCID/50 (1 virion particle) in test articles.VIEW AVAILABLE TESTS
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 Pharmacopoeia (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.VIEW AVAILABLE TESTS