Downstream process development and validation

Any facility involved in production of a bio/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 network of laboratories offers a comprehensive range of services to help drug manufacturers achieve compliance through a variety of process validation tests, including:

• Bioprocess Residuals
• Viral Clearance
• Facility Monitoring and Support
• Extractables & leachables
• Cleaning Validation and Disinfectant Efficacy Studies

LabAcess

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