Monoclonality Verification for Cell Line Development
Validation that cultures originate from a single cell is challenging, time intensive and can affect the success of cell line development. Regulatory bodies worldwide require images of cell cultures over time series to ensure cultures derive from a single cell and that products will not be heterogeneous.
Our Danaher Life Sciences companies provide several solutions for verifying monoclonality in cultures, giving you the flexibility to take control of the process and meet your unique workflow goals and metrics.
- Automate limiting dilutions with a Beckman Coulter Biomek i-Series Automated Workstation, allowing you to make this inefficient and pipette-intensive task hands-off.
- Sort cells directly into individual cultures in a microplate with a Beckman Coulter CytoFLEX SRT Benchtop Cell Sorter.
- Acquire images from cell culture plates with a Molecular Devices CloneSelect Imager. Reporting can be easily automated or integrated into an existing cell culture workflow.
- Screen cultures and produce evidence of monoclonality with a Molecular Devices ClonePix 2 Mammalian Colony Picker, an all-in-one hands-off solution that can perform cell culture, screen colonies and protein product, and monoclonality verification imaging on one instrument.
- Data acquisition and management by the IDBS Polar Biopharma Lifecycle Management platform can ease regulatory compliance.
Genedata Bioprocess increases the efficiency of the end-to-end cell line development workflow, encompassing plate management, pool and cell line tracking, data aggregation from instruments, selection decision-making, cell bank inventory and cell line history reporting. It facilitates workflow automation, barcoding, and high-throughput processes, capturing all data in a structured format to create a robust data foundation for predictive modeling and AI/ML.