BioOutsource’s service in adventitious virus testing is
based upon a strong understanding of virology and many
years of experience in virus safety testing for a wide
range of products from monoclonal antibodies to live
virus vaccines and gene therapies....
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BioOutsource’s service in adventitious virus testing is
based upon a strong understanding of virology and many
years of experience in virus safety testing for a wide
range of products from monoclonal antibodies to live
virus vaccines and gene therapies.
BioOutsource’s facilities and services have been
inspected by the UK MHRA and are GMP compliant.
Virus safety testing is carried out in compliance with GMP
and with the following regulatory guidance:
European Pharmacopeia Guidelines 2.
6.
16: Tests for•
Extraneous Agents in Viral Vaccines for Human Use
Q5A (Viral Safety Evaluation of Biotechnology•
Products Derived from Cell Lines of Human or Animal
Origin – 1997)
“Points to Consider in the characterization of cell lines•
used to produce biologicals” (FDA, CBER, 1993)
BioOutsource extensive validation package provides a
detailed report on the validation of the assays to ICH
guidelines and is available to all clients to use as part
of their regulatory submission; facilitating regula
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