Raw Material and Serum Testing

Regulatory compliance testing for adventitious viruses, mycoplasma, and bacteria in animal origin products used in the pharmaceutical and biotechnology industries.

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.

AVAILABLE TESTS

STERILITY TESTING

STERILITY TESTING

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

AVAILABLE TESTS

EMA and EP VIRUS TESTING

STERILITY TESTING

Validated assays for detection of adventitious viruses and neutralizing antibodies in bovine serum and other bovine materials.

AVAILABLE TESTS

MYCOPLASMA TESTING

STERILITY 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>)

AVAILABLE TESTS

BOVINE POLYOMAVIRUS (BPyV) TESTING

STERILITY 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.

AVAILABLE TESTS

SENECAVIRUS A (SVA) TESTING

STERILITY 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.

AVAILABLE TESTS