Release Testing

Purified Bulk and Finished Product

Charles River offers a comprehensive GMP service for the release of biological products into the US, EU, and other global markets.  Appropriate studies for the determination of purity and impurity levels as well as identity and characterization of physicochemical properties can be transferred from the sponsor as required. Careful management of the technology transfer phase allows us to successfully and promptly establish appropriate protocols at our facilities.  We also extend a service designed to develop and validate product-specific assays customized to the requirements of your product.

Following the changes in EU legislation (Clinical Trials Directive, May 2004), we can provide QP (Qualified Person) functions for the release of IMPs (Investigational Medicinal Products).

In vitroBioassays

In addition to traditional characterization methods, we routinely perform in vitro bioassays either separately or as part of complete product release or stability packages. We have extensive expertise in transferring client technologies and validating methods for these complex assays. Types of bioassays conducted range from cell proliferation and cell survival to emerging technologies using reporter genes as appropriate end points.

Virus and Sterility Testing

A full release testing service of bulk products to confirm the absence of viruses by in vitro screening, PCR testing, and standard sterility testing is offered.

Unpurified Bulk Material

Our Biopharmaceutical Services Biosafety Testing and Analytical Chemistry Program includes validated assay protocols for the most commonly used raw materials.  We extend a service designed to develop and validate raw-material-specific assays customized to meet your individual production process.

Data Sheet: Drug Product Release Testing

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