Automated Disulfide Bond Mapping in Comparing Innovator and Biosimilar mAbs Using UNIFI Software

Library Number:
APNT134892431
Part Number:
720005698EN
Author(s):
Henry Shion, Min Du, and Ying Qing Yu
Source:
Waters
Content Type:
Application Notes
Content Subtype:
Application Notes
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In this application note, we describe a streamlined disulfide bond mapping analysis workflow using the Waters Biopharmaceutical Platform Solution with UNIFI. An innovator biologic, infliximab, is compared with a biosimilar.

This application note demonstrates successful application of the described workflow to identify all expected disulfide bonds from the Waters mass check standards. Additionally, it demonstrated the comparability between innovator and biosimilar infliximab samples.

Combined with the UNIFI compliance-ready architecture, this disulfide mapping workflow can help biopharmaceutical organizations overcome analytical challenges, and complete fast mapping and monitoring of disulfide bonds during the development and manufacturing of their biotherapeutic products.

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