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Cell and Virus Characterization

Mycoplasma USP 63

Welcome to the homepage for Cell Line Characterization and Virology Testing.

At BioReliance, we offer a wide range of assays and services aimed at ensuring the quality and purity of cells and viruses used in the production of biologicals for the pharmaceutical and biotech industries.

Cell Line Characterization studies are required by regulatory agencies for two major purposes:

Cell Line Authentication - To ensure cells used in the production of large scale biologicals remain genetically consistent with initial cell lines used to produce recombinant proteins, monoclonals, or enzymes.  Genetic drift and selection pressure in cell culture can cause immortalized cell lines to fix mutations that may alter genomic DNA.  This can lead to changes in expression patterns of biologicals or post-translational modifications (glycans) that effect efficacy in vivo.

We offer extensive assays for cell line authentication including Isoenzyme Analysis, Karyotyping, DNA Analysis, RAPD, Tumorigenicity, Oncogenicity, and Genetic Stability Studies.

For more detailed information see our cell line authentication page.

 

Adventitious Agents - Cultured cells used in the production of biologicals are subject to infection by microbes and viruses that can cause harm to patients if not detected. Regulatory agencies require testing for adventitious viruses and microbes like mycoplasma that are common contaminants that lead to bioburden in biologicals production.


We offer extensive assays for the detection of adventitious agents in cell banks and end-of-production cells including mycoplasma testing, sterility assays, bioburden, and a range of microbial detection assays by q-PCR.


For more detailed information see our Mycoplasma and cell line purity page.


Virology Testing - Of special importance are biosafety assays to detect adventitious viruses in working cell banks, master cell banks, virus seed stock, raw materials and final products.  Viruses are universally present in cell lines and mammals used to produce biologicals and in the livestock industry, so regulatory guidelines require testing for safety of patients and for consumers of beef and pigs. 


BioReliance CRO’s virology testing services include in vitro assays, in vivo assays (MAP), and a range of assays to detect retroviruses. 


For more detailed information see our virology testing home page.