| Microsafe Services - Adventitious Virus Testing | Data Sheet - SDS1706ENEU | |
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A major concern when using mammalian cell lines for production of a biotechnology product is the risk of viral contamination. Such contamination could have serious clinical consequences; in particular, the administration of the contaminated drug could be detrimental to the patient. Drug contamination can arise through the introduction of adventitious (accidentally introduced) viruses during the manufacturing process. The likely sources of contamination include the use of contaminated cell culture media, a breakdown in GMP allowing operator or other external contamination, or the use of contaminated reagents used in the process, such as a monoclonal antibody affinity chromatography column.1
These contaminations require the development of suitable analytical techniques to ensure the absence of human and animal adventitious viruses.