Adventitious Agents

At MDS we test for adventitious agents by detection of cytopathic effects on indicator cell lines such as MRC-5 cells, Vero cells, and a number of other different cell lines, per guidance outlined by the regulatory agencies (US Food and Drug Administration (FDA PTC 1993 and others) and the International Conference on Harmonisation (ICH Q5A). Customers may also request this testing be modified to accommodate certain other sample types, as desired. According to FDA and ICH guidance for viral safety, the testing requires that a sample of biological product be tested on a human and a primate cell line, as well as being tested on (at a minimum) a cell line of the species and tissue type that is used for production of the biological product.

We offer a range of differently sized culture vessels to accommodate your specific samples. We tailor our in vitro tests to your unique specifications and offer fully validated assays to meet regulatory requirements. Three to five susceptible indicator cell lines are cultured in triplicate. One group of the cultures is infected with a range of control viruses. A second group is left untreated as negative controls. The remainder is inoculated with the 'test' cell line. All the cultures are subsequently examined for cytopathic effects and hemadsorption.

Our tests may be conducted in a variety of culture vessel sizes and with a variety of cell lines, as requested by the customer. Available cell lines include Vero, MRC-5, BHK-21, CHO-K1, NIH-3T3, SP2/0-Ag14, A9, A549, BT, GT, ST, MDBK, and more.

In most cases, product samples are inoculated into each of the cell lines above and the resulting inoculated cultures maintained for at least 14 days. The test is often extended to 28 days, especially if the sample originates from a cell type that can support the replication of human cytomegalovirus. The cultures are observed regularly for the development of cytopathic effects (CPE) throughout the culture period.

At the end of the given period, the cultures will be tested for hemadsorption or adherence of red blood cells to cell surfaces. The observation of CPE and/or hemadsorption indicates the presence of an adventitious agent. As a final result, we report whether adventitious viruses were detected in the sample. Reporting time for this in vitro testing is 5 weeks.

Available Cells Lines
Adventitious Viral Contaminants in Mammalian Cell Bank
Adventitious Viral Contaminants in Virus Seed
Adventitious Viral Contaminants in FBS (Serum)
Adventitious Viral Contaminants in Trypsin

 

AVAILABLE CELLS LINES

Adventitious Viral Contaminants in Mammalian Cell Bank :Tests performed in 6-wells plates

 

Adventitious Viral Contaminants in Virus Seed (500 doses or 50 ml). Test performed in T-75 flasks

For testing inactivated virus vaccines, sero-neutralization should be performed before inoculation onto
indicator cell lines. Transferred client protocols or custom sero-neutralization protocols will be used.

Should you select to use other detector cell lines, do not hesitate to contact us.