GMP Lot Release Testing Services
Charles River provides GMP lot 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.
Over the past 20 years, we have gained valuable experience generating data in support of more than 10,000 batches of various protein and small molecule products. Each year, the Biologics group performs full specification lot release testing 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.
Characterization and Lot Release Assays for Antibody Drug Conjugates (ADCs). View The Poster
Typical GMP Lot Release Testing Program
- SDS-PAGE with western blot or CE-SDS
- Isoform analysis (IEF, C-IEF)
- Purity and Impurities
- pH determination
- Osmolality determination
- Visual assessment
- Determination of volume in syringes and vials
- Determination of excipient levels
All marketed products or investigational medicinal products (IMPs) manufactured outside the EU require re-testing at an EU-based facility and, through the Mutual Recognition Agreement, at our facilities in the US. This service is available at our local European facilities.
Batch release 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 testing program at a contract research organization (CRO). 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, focus on communication, and rigorous documentation and study performance enables us to support clients in the most effective and timely manner possible.
Frequently Asked Questions (FAQs) About Lot Release Testing
What’s lot release testing (batch release testing)?
Lot release testing tests a batch of drug substance or finished product against the registered specification for that material to ensure compliance for all attributes.
What does GMP lot release testing entail?
Fully validated methods are used to test the material to ensure all attributes are within the range established during safety and efficacy studies.
What are the regulatory guidelines on GMP lot release testing?
All marketing authorizations contain the accepted specifications for the drug substance and finished product. The specifications accepted by different regulatory authorities can vary. The authorization to market a product requires that each production batch of the drug substance and finished product are tested.
In addition, some regulatory authorities, notably the European Union, require that this testing is performed within their regional boundaries or under the approval of another regulatory authority with which they have a Mutual Recognition Agreement on GMP (e.g., US and Canada in the case of the European Union).