Streamlining Clone Cell Line Development Workflows
Cell line development (CLD) is the process of creating genetically engineered cells that stably produce a specific protein or biomolecule of interest, primarily for use in research, biopharmaceutical production, and therapeutic applications. This critical process involves the selection, modification, and expansion of host cells to ensure consistent and high-yield production of biologically active proteins.
Scientists encounter an extensive setup process in cell line development to achieve stable production of the desired product at high yields. The key steps in cell line development include:
- Cell engineering
- Cloning methodology and monoclonality confirmation
- Clone assessment
- Analytical testing
- Upscaling
Some of the main challenges in generating stable cell lines include low seeding efficiency, poor outgrowth, and the necessity for seamless traceability and proof of monoclonality. To overcome these issues, CYTENA has developed the UP.SIGHT™, (a 2nd Generation, single cell dispenser and imager), and C.STUDIO Cell Line Development Software. This powerful combination streamlines the clonality methodology, monoclonality confirmation, and clone assessment, enabling users to focus on other critical aspects of the process. With CYTENA’s advanced technology, cloning and monoclonality confirmation have become significantly easier and more efficient.
The Streamlined Cell Line Development Workflow
The initial steps in cell line development set the foundation for the creation of stable, high-yielding cell lines. Additionally, The U.S. Food and Drug Administration (FDA) and European Medicines Agency impose specific regulatory requirements for proving monoclonality, especially when it comes to the production of biologics, such as monoclonal antibodies and other therapeutic proteins. Monoclonality assurance is crucial to ensure consistency, safety, and efficacy of biologics derived from cell lines.
After the cell engineering step, it is critical that steps around cloning methodology are streamlined reducing timelines in clone selection and facilitating data traceability to meet regulatory requirements. Scientist can reduce face time consuming steps in initial seeding and documenting that initial seeding, the UP.SIGHT can deposit cells in a manner that statistically ensures single cells are placed in each well of a microplate thus removing such complex task from the user.
The UP.SIGHT system efficiently isolates single cells with a high degree of confidence, followed by its imaging feature, which allows users to visually confirm throughout the subcloning process that colonies are indeed growing from single cells. With an impressive >97% single-cell seeding efficiency, the UP.SIGHT significantly reduces the number of well plates required. It also achieves up to an 80% clonal recovery rate through gentle dispensing, enabling scientists to achieve the desired number of clones with fewer plates and allowing them to work with more sensitive cell types. CYTENA has published a detailed validation study and optimization paper, demonstrating an optimized and validated workflow for developing stable producer cell lines with >99.99% assurance of clonality and high clone recovery, providing users with a solid foundation to start their workflows.
Regulatory compliance requires forward-looking approaches and advanced technology, which is where the C.STUDIO software proves invaluable. It seamlessly integrates with the UP.SIGHT system to trace and manage all relevant data, meticulously documenting every step, methodology, and result. This thorough documentation is crucial for regulatory submissions and future reference. C.STUDIO organizes the data into a format that is suitable for submission to regulatory authorities, such as the FDA, as part of an IND or BLA.
Additionally, productivity assessment often necessitates the use of other systems. The UP.SIGHT, paired with the F.QUANT kit, allows for titer measurements, and with the data gathered by C.STUDIO, users can easily select high-producing clones.
This streamlined workflow utilizes a single device and software, minimizing the complexity of working with multiple devices and avoiding compatibility issues that can arise from handling various data formats.
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This post is sponsored by CYTENA.