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FDA-Accepted Monoclonality Assurance on the Beacon® Optofluidic System for Cell Line Development

Learn how the Beacon system’s superior cloning technology, automated imaging capabilities, and in-process quality controls provide definitive evidence of monoclonality to support regulatory approvals.

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What's Inside

In this App Note we discuss:

Industry leading technology for confident assurance of clonality in regulatory submissions.
Rapid, automated workflow provides a complete end-to-end image record of every clone.
Independently validated >99% probability of monoclonality with a single round of cloning.
A Deeper Look

More about this App Note

FDA-Accepted Monoclonality Assurance for CLD

The Beacon system provides a high probability of maintaining >99% monoclonality when operating the workflow according to recommended procedures. These data have been and can confidently be included in IND and BLA applications to the FDA in support of a biologics drug approval. Download to learn more and review the case studies.

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