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We are proud of our history and world-class reputation of leadership, having pioneered significant testing programs - from testing for the first polio vaccine to present-day gene therapies. Our capabilities include a broad spectrum of cGMP- and GLP-compliant biosafety, virology, immunochemistry, molecular biology and microbiology testing services. Our unique ability to develop and execute global protocols enables BioReliance’s clients to register products worldwide.
The molecular analyses of cells and biopharmaceuticals can provide critical information in establishing the identity of cells and presence of contaminating viruses. Our Molecular Biology services are comprehensive to address your needs.
Our Virology services assist clients with their virological and cell-based testing requirements. We are ready to provide clients with regulatory and testing advice and to supply expertise in assay transfer and assay development for all stages of the drug development process from early proof of concept experiments to analysis of final product material.
There is an almost universal requirement to test at most stages in biopharmaceutical production for mycoplasma, bacterial and fungal contamination. Our Microbiology services are comprehensive to address these issues.
Our Cell Biology services provide essential information for the
characterization of cell substrates and their products. We provide
analysis based on light and electron microscopy including structural
and ultrastructural identity of tissues, cells, micro-organisms
and viruses; antibody specificity and immunocytochemical localization;
analysis of genome structure and stability.
Analytics is a broad term covering investigations performed in Analytical
Chemistry, Bioanalytical and Immunoassay.
Our Analytical Chemistry group was set up in
1999 and is housed in well-equipped laboratories with up-to-date
analytical instrumentation, including extensive chromatographic
and electrophoretic equipment. The group, which is based on two
sites in the UK and the US, offers comprehensive services for all
your lot release, stability testing, assay development and routine
testing needs.
The Bioanalytical and Immunoassay departments
are located in both the US and UK. The departments offer a comprehensive
service in analysis of test samples for stability and potency using
a variety of biological and immunoassay methods. Services offered
include assay development and validation, stability testing, potency
testing and analysis of purified drug & final drug products
for contaminating host cell proteins or contaminating reagents.
BioReliance’s Clinical Trial Support Services has significant
experience in the testing of viral vectors and vaccines. 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 the presence of anti-virus neutralizing antibodies
and cytokines, evidence of viral shedding or expression of the delivered
gene. Additionally, there is increasing Regulatory interest in Neutralizing
antibodies produced by patients treated with therapeutic proteins.
BioReliance can offer a custom service to detect neutralizing antibodies
directed to therapeutics using up-to-date instrumentation. Many
of these analyses involve the development of specialized assays
that are not routinely performed by most Clinical Research Organizations.
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