Molecular Diagnostics Services, Inc.
A Contract Research Organization

TRANSMISSION ELECTRON MICROSCOPY (TEM) for Detection of Adventitious Agents in Cells

Regulatory guidelines: ICH Q5A; 1993, 1997 PTC


Electron Microscopy

MDS offers TEM services to detect viral particles in general and retroviruses in particular in test articles and bell banks.  If the test article is seen to be contaminated with retroviruses by observation of the cell line in TEM, the detection of retrovirus is then confirmed by direct assays. Regardless of whether retroviruses are present in the MCB, WCB or EPCB, the unprocessed bulk supernatant should be tested to determine the retroviral titer. It is essential to quantify the retrovirus, preferably using TEM as specified in “Points to Consider in the Manufacture and Testing of Monoclonal Antibody Products for Human Use”

MDS offers the following TEM services

Additionally, MDS provides custom services in which an indicator cell line (e.g. Vero, MRC-5, BT or PPK) is inoculated with the test product. The cells are then examined by TEM, to visualize the virus particles, and identify the viral species involved

Submission of Samples: Samples for testing can be submitted as either a growing culture or a frozen cryovial.

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