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.
|Upcoming Seminar: "Transfer, Design and Execution – Best Practices in Biologics Quality Control Testing"|
In this seminar at our new Analytical Center of Excellence in Shrewsbury, MA, our scientists will discuss critical factors that need to be considered when designing and transferring analytical assays. Register Here
Release Testing Capabilities
- Purity and impurities
- Physicochemical properties
- Presentation attributes