Cell Banking & Process Validation

Any facility and process involved in production of a pharmaceutical product has a significant impact on the quality of the end products it manufacturers. To certify the safety and effectiveness of these products, regulatory agencies require testing to monitor and validate the on-line and off-line performance of the manufacturing process to ensure the appropriate process control procedures are in place.

As a pioneer in the Microbiology, Chemistry, Biochemistry and Biosafety testing for more than 25 years, Eurofins BioPharma Product Testing offers a comprehensive range of services to help drug manufacturers achieve compliance through a variety of analytical tests, including:

• Cell Bank Preparation
• Cell Line Characterization & CHO
• DNA Sizing and Barcoding
• Bioprocess Residuals
• Viral Clearance
• Facility Monitoring and Support
• Cleaning Validation and Disinfectant Efficacy Studies