Confident clonality assurance for a successful IND
Assess monoclonality, automate cloning and imaging, and provide a superior data package
The first IND application incorporating monoclonality assurance data from the Beacon® system has been approved by the FDA
The Beacon system’s optofluidic chip technology and integrated imaging provide direct evidence of >99% monoclonality, without the manual effort and uncertainty of traditional methods. Optofluidic chip NanoPen™ chambers are 700x smaller than a microplate well leaving nowhere for “ghost cells” to hide.
Automated imaging at every step for a complete visual record of every clone
Clonality assurance independently validated
“Clonality assurance on the Berkeley Lights Beacon platform follows the same imaging and validation paradigm [as microscopic imaging and verification]. However, through improved integrated imaging capability, cell detection algorithms, and in‐process quality controls, the Beacon provides an overall stronger data package for single cell progenitor assurance.”
Kim, L et al., Amgen. Read paper.
Overall clonality assurance rates determined by Le et al.
Want to learn more?
Download the application note on: FDA-Accepted Monoclonality Assurance on The Beacon® Optofluidic System for Cell Line Development to learn how 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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