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 TESTSSterility Testing
VMRD offers Bacteria and Fungi testing methods to satisfy USDA-APHIS 9CFR 113.26 for Animal Origin Products. Assay meets 113.25 requirements.
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Mycoplasma Testing
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 TESTSBovine 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.
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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.
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