FDA-Accepted Monoclonality Assurance On The Beacon® Optofluidic System For Cell Line Development

In recent years the FDA and other regulatory authorities have increased their emphasis on proof of monoclonality of mammalian cell banks, as referenced by FDA guidelines, ICH Q5D, and EMA/CHMP. While there is no explicit regulation stating that a production cell line should be monoclonal, a clonally derived Master Cell Bank is seen as a critical component of a robust, consistent process that ensures drug product quality and safety. Insufficient evidence of clonality in a regulatory submission may necessitate additional manufacturing controls and lead to costly delays of clinical trials and/or drug commercialization.

This application note demonstrates how the Opto™ Cell Line Development workflow on the Beacon® system provides:

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