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BioReliance Launches Next-Generation Genotoxicity Screening Service
BioReliance has contracted with Gentronix to offer their GreenScreen HC in vitro assay as a major part of BioReliance's portfolio of genotoxicity screening services. GreenScreen HC, in conjunction with Ames II assays, allows pharmaceutical companies to test for genotoxic potential earlier in the preclinical development process, using only a few milligrams of test compound as opposed to the gram quantities required by current ICH regulatory tests. Click here to read the press release.
Bioreliance Launches iNet, a Web-Based Tool for tracking Electronic Submissions of Biologics Tests
BioReliance is pleased to announce the release of iNet, a proprietary information technology system for submitting and tracking test article details via a controlled and secure Internet access from any location worldwide. Now you can view the status of current and past studies, keep informed of when testing will be completed, download reports, and allow your colleagues to view the status of your tests. iNet is currently available to US biologics testing customers upon request, but will be made available to a larger audience soon. Click here to read the press release.
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BioReliance is the leading provider of contract services
to the biopharmaceutical industry, supporting every phase of the testing,
development and manufacturing process and offering a comprehensive and
integrated package of services.
Our clients include producers of traditional pharmaceuticals, medical devices, chemicals and other products as well as biopharmaceuticals.
BioReliance has been the scientific leader in biological
safety assessments for over 50 years - 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.
BioReliance has been conducting viral clearance studies
for European, Asian and US clients since 1984. These studies are required
to assess the ability of the manufacturing process to produce a product
that is safe for use in humans. Many biologics such as plasma derivatives,
monoclonal antibodies, recombinant proteins and medical devices have been
licensed around the world using data generated from viral clearance studies
performed by BioReliance. Our clients include many of the world's major
pharmaceutical and biotechnology companies.
BioReliance is dedicated to meeting your manufacturing
needs for the production of viral therapeutics, cell therapeutics and
microbially expressed protein products. Our current Good Manufacturing
Practices (cGMPs) production facilities and extensive technical and regulatory
expertise provide the support you need for efficient product development
and the guidance you trust to achieve regulatory approval.
BioReliance provides GLP compliant genetic, in vivo and molecular toxicology testing on pharmaceutical, biopharmaceutical,
medical device or pesticide products. Our scientific staff and state-of-the-art
facilities provide the most complete and comprehensive toxicology resources
available anywhere. We are recognized internationally for our experience
in the successful management and performance of multidisciplinary biomedical
and toxicological research projects.
At BioReliance, Analytical Services involve the testing of biotechnology products to show that their molecular structure meets predefined criteria and that the macro-molecules remain safe, stable and efficacious in the final product formulation. In these studies, the product is physiochemically characterized using a variety of standard and state-of-the-art analytical methods.
BioReliance’s Laboratory Animal Diagnostic Services
(LADS) department provides diagnostic services for all of your testing
needs, offering a complete spectrum of animal diagnostic and analytical
services for both routine monitoring and emergency situations. These testing
programs are used by laboratories, breeding colonies and animal facilities
worldwide. We are the one of the few commercial organizations to provide
both rodent and simian diagnostics.
BioReliance’s Clinical Trial Support Services has significant experience in the manufacturing and 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 shed virus, expression of the delivered gene, presence of anti-virus neutralizing antibodies and cytokines. Many of these analyses involve the development of specialized assays that are not routinely performed by most Clinical Research Organizations.
In a fast changing global economy, BioReliance has
the regulatory expertise and facilities to help clients move their products
to market in the fastest, most efficient manner. We also set the highest
quality and customer service standards for all our clients' projects.
Quality Systems
Project Management and Client Services
Regulatory and Technical Support
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