Bulk Harvest/In-Process Samples

Tests for sterility, mycoplasma and virus contaminants in bulk harvest or in-process samples help ensure safety in the resulting biological products. Our in vitro test detects adventitious agents using MRC-5 cells, Vero cells and a number of other different cell lines, according to regulatory guidances.

MDS offers flexible testing for adventitious agents that have potentially contaminated a manufacturing process. We can provide a range of differently sized culture vessels to accommodate your unique samples. In fact, we can extensively tailor our in vitro tests to your custom specifications. To meet regulatory requirements, our assays are fully validated.

Since cell lines may have been exposed to animal-derived materials, MDS also offers testing for bovine and porcine viruses. These assays follow the regulations outlined in the US Code of Federal Regulations, Animals and Animal Products, Title 9 (9 CFR), with widely acknowledged MDS accuracy and reliability. MDS also offers a number of tests to detect infectious murine or retroviruses.