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. The area of each Optofluidic chip NanoPen™ chamber is ~700 times smaller than that of a microwell, 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 the Beacon system’s superior cloning technology, automated imaging capabilities, and in-process quality controls provide definitive evidence of monoclonality to support regulatory approvals.