All products entering local or global pharmaceutical markets require current Good Manufacturing Practice (cGMP) testing to ensure that they are released in accordance with regional and global regulatory authority approvals. Release testing comprises a range of studies previously validated to demonstrate compliance of a product. The Biopharmaceutical Services (BPS) group at Charles River provides product release testing services for client-derived and BPS-derived intermediate and final drug products. BPS provides release services for the EU, US and other regulatory-distinct markets and can act as a single site for global release testing for clients.
To ensure that your specifications for product release are met, BPS will work closely with you to develop a technology transfer package, if required, for assays you have developed and which are subsequently implemented by BPS.
We provide a full range of support, from addressing biosafety concerns and analyzing potency using suitable bioassays to determining purity and other biochemical characteristics. Our experience gained from the establishment of methods currently used to test over 20 licensed products and our commitment to providing rapid turnaround times for all testing helps minimize the period between production and release.
To check which of our BPS facilities offer lot and final drug product release testing and get local facility contact information, click here. For additional information, contact us at askcharlesriver@crl.com.