Cell Bank Characterization
Microtest provides characterization for cell banks used in the production of various biological products. We offer a number of fully validated tests to satisfy the requirements of guidance documents from the relevant regulatory agencies.
Our testing determines the presence of general and specific contaminants in these cell lines, helping ensure the safety of the resulting biological products. We test for sterility and for the presence of mycoplasma, as well as for viruses. Our in vitro test detects adventitious agents using MRC-5 cells, Vero cells, and a number of other different cell lines, per guidances outlined by the regulatory agencies.
We can offer a range of differently sized culture vessels to accommodate your specific samples. In fact, we can tailor our in vitro tests to your unique specifications. And we offer fully validated assays to meet regulatory requirements.
Since many cell lines used in the biotech industry are either grown in the presence of animal-derived raw materials or had been exposed to these materials at some point in their history, Microtest also offers testing for bovine and porcine viruses. These tests follow the regulations outlined in the U.S. Code of Federal Regulations, Animals, and Animal Products, Title 9 (9 CFR) with renowned Microtest reliability.
Depending on the nature of the cell line, tests for murine or mouse-based retroviruses may also be needed. Microtest offers a panel of sensitive tests to detect infectious murine retroviruses.
In addition to the above cell bank characterization testing, Microtest plans to offer isoenzyme analysis of cell lines for identity testing.
See details on our specific testing:
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