| Clinical trials
with viral vectors and vaccines may require additional tests beyond
the standard clinical chemistry and hematology required for other
clinical trials. These additional assays may include an analysis
of patient samples for shed virus, expression of the delivered gene,
presence of anti-virus neutralizing antibodies and cytokines. Additionally,
there is increasing Regulatory interest in neutralizing antibodies
produced by patients treated with therapeutic proteins. Many of
these analyses involve the development of specialized assays that
are not routinely performed by most Clinical Research Organizations.
BioReliance can offer a custom service to detect neutralizing antibodies
directed to therapeutics using up-to-date instrumentation. BioReliance has state-of-the-art facilities, expert
staff and well-documented sample tracking and reporting systems
that allow for the efficient analysis and reporting of the large
number of samples generated in human clinical trials. Our experience
enables BioReliance to offer a seamless service to our clients involved
in clinical trials. At BioReliance, all services are performed according
to the principles of GLP. In addition to this, work conducted within
the Clinical Trial Support Services division is compliant with GCP.
Clinical trial Support Services include:
Detection of Vector Infectivity
Detection of Viral Vectors by Q-PCR
& RT-PCR
Detection of Expressed Recombinant Protein
Detection of Total & Neutralizing Antivector
Antibodies
Detection of Cytokine Response
BioReliance Analytical Services employ a wide
range of methods and techniques to ensure that your product is well
characterized. Our services include:
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