Gene therapy clinical trial support


		Introduction Vector Infectivity Viral Vectors by Q-PCR & RT-PCR Expressed Recombinant Protein Neutralizing Antivector Antibodies Cytokine Response Additional Services

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.

BioReliance has significant experience in producing and testing gene therapy viral vectors.

Additional Services

BioReliance offers additional clinical trial support services to sample analysis. These services include:

Performance of GLP Potency Assays
Potency assays are required for most biological products and form part of a panel of lot release assays. Potency assays can be validated for accuracy, linearity, precision, range, limit of detection (LOD), limit of quantification (LOQ), repeatability, and robustness. We have experience in performing potency assays for the cGMP release of licensed biological products.

Assay Development
The assays used for sample analysis depend on the vector used. We work with the sponsor by using pre-existing established assays, developing new assays, or transferring assays from the sponsor. For more information on this offer or to discuss the specific requirements for your studies, please contact us.

Sample container delivery to clinical sites worldwide; Logistical support for the global collection and cold shipment of samples; Clinical sample receipt and storage at –70°C

These services are supported by our experience and resources to handle large numbers of samples as well as the ability to ship containers and collect samples from sites worldwide. Our labelling system has been devised for accurate tracking of samples through collection, storage and testing and our Patient Sample Collection Forms ensures that we have the necessary sample information for accurate testing and reporting.

for further information and enquiries please contact: info@bioreliance.com