mAbs Final Product Release Testing

Every lot of monoclonal antibodies produced for preclinical and clinical studies requires a series of tests to ensure that active ingredients are free of contaminants according to 21 CFR 211.165 and 21 CFR 610. Our comprehensive spectrum of cGMP-compliant final product testing services provides assurance of patient safety and regulatory compliance in any geography, with service provision on three continents and backup facilities to ensure continuity of supply.

You can rely on our knowledge, capabilities, and vision with complete confidence at any stage of the biomanufacturing process. Our recommended final product release testing services include:

• Sterility by membrane filtration
• Sterility by direct inoculation (14 day Sterility)
• Endotoxin (LAL)
• Characteristics of the final product

To discuss your final product release testing needs, use our reply form and get in touch today.