GMP Release Testing Services
Charles River provides release testing services for bulk drug substances and clinical and marketed products for the European Union (EU), United States (US) and other regulatory-distinct markets, and can act as a single site for your global release testing.
Our highly experienced team is committed to successful long-term relationships with our product release clients. We have gained valuable experience over the past 15 years generating data in support of more than 8,000 batches of various protein and small molecule products. Each year, we perform full specification release tests on over 500 batches of 22 final products and single tests on many more. We work closely with operational staff, offering flexibility to meet clients' manufacturing schedules.
Typical Release Testing Program
|Identity||Potency||Purity & Impurities||Physicochemical Properties||Presentation Attributes||Microbiology|
|SDS-PAGE with western blot or CE-SDS||Cell-based potency assays||Residual DNA/host cell protein||pH determination||Visual assessment||Sterility testing|
|Isoform analysis (IEF, C-IEF)||In vivo potency||Size-exclusion HPLC of proteins||Osmolality determination||Determination of volume in syringes and vials||Microbiology assays|
|Protein characterization||Cation-exchange HPLC of proteins||Determination of excipient levels||LAL/monocyte activation test, in vivo pyrogenicity|
|Binding assays||Reverse-phase (RP) HPLC of proteins||General safety/ abnormal toxicity|
All marketed products or investigational medicinal products (IMPs) manufactured outside the EU require re-testing at an EU-based facility. We can provide this service through our local European facilities. Testing programs may include differing combinations of microbial testing, biochemical analysis, purity, safety and potency testing, as required by the regulatory authority for market entry.
Controlled management of technology transfer is key to the efficient establishment of an effective lot release program at a contract research organization. Our team initiates discussions with clients regarding their methods at the earliest stages, and carefully studies how their process is actually conducted. This approach allows us to transfer and establish client methods at our facility in the shortest timeline, and maintain control of these methods throughout the life of the product. Our experience with technology transfer, our focus on communication and our rigorous generation of documentation and study performance enables us to support the client in the most effective and timely manner possible.