Process Validation in Biopharmaceutical Production
The Biopharmaceutical Production Process should be suitable to deliver a Biological of continuous quality. To demonstrate that your process is effective and reproducible, Process Validations are key.
Since in Biologics the production process is influenced by many parameters, different aspect should be part of the validation.
Analytical support is key for process performance qualification. Eurofins BioPharma Product Testing Netherlands is able to support your Process Validation activities.
Samples for testing are collected from start till end, including the cells, the media,
and the final product.
- Process-related impurities should be removed from your process in an effective way. We can help you to demonstrate their effective removal.
- Viral Clearance: In a Viral Clearance study, the virus reduction capabilities of a production process is monitored. Heat treatment, Solvents, Chromatography and Virus removal filtration are examples of process steps resulting in viral clearance. EBPT-NL offers a broad panel of viruses for your Viral Clearance study.
- Cleaning Validations
- Extractables and Leachables
Please contact us for more information about these services.