The ClonePix® 2 Mammalian Colony Picker is a fully automated system for selecting high-value clones used in antibody discovery and cell line development. Screen more clones in less time with monoclonal verification on day zero, then screen and identify for highest producers in weeks, not months.
Hybridomas, CHO cells, stem cells and other cell types are imaged and selected based on user-defined parameters. Plate handling, barcode reading, and picking are fully integrated, and all data, including images, are saved for downstream analysis. The picker increases the probability of finding optimally produced cell lines and significantly reduces time and labor.
Empower your team with data analysis that automatically generates a map of clones and their secretion levels from a series of images generated in situ. The ClonePix can also be customized to include image-based monoclonality assurance on day zero.* This means your team can screen in one round and then pick for the highest produces in weeks, not months.
All relevant data associated with each colony (including images taken before and after picking along with their picking coordinates) are automatically saved for review and downstream analysis.
The enhanced ClonePix 2 system can automatically screen and pick clones that are both high producing and monoclonal—all in one system. Screen more clones in less time with monoclonal verification on day zero, then screen and pick for highest produces in less than two weeks.
High-resolution imaging identifies desirable, clonal stem cell colonies for high-throughput colony screening and picking. Specialized picking pins allow the gentle transfer of adherent, feeder-free cells to high-density plates for clonal expansion and downstream analysis.
*Price, time to deliver, and specifications will vary based on mutually agreed technical requirements. Solution requirements may cause an adjustment to standard performance.
Custom solutions are subject to Molecular Devices Custom Products Purchase Terms.
Cell line development is a critical step in the process of generating biopharmaceutical molecules, such as monoclonal antibodies. The process often begins with transfecting the host cell type with the DNA encoding the therapeutic protein of interest allowing for random or directed integration of target DNA into the host cell genome. Thousands of clones are screened to isolate the rare high producing cells, a manual and time-consuming process.
Many proteins that express to the surface of cells are targets for the discovery and development of biopharmaceuticals. For instance, G-protein coupled receptors (GPCRs) are the largest class of cell-surface proteins and are targets for almost 40% of existing drugs. Discovery and selection of high value clones with elevated cell surface expression of GPCRs from a transfected pool of cells can be challenging. The ClonePix 2 System represents an automated method of screening large populations of cells that increases the probability of finding rare high-affinity binder or high producer.
An important component in identifying high-value clones is determining productivity of single cell-derived colonies. Screening for productivity using traditional approaches is laborious and time consuming, generally consisting of a multistep process that involves isolating single cells from limiting dilution followed by assessment of titer using ELISA. The ClonePix 2 system combines phenotype selection, single-cell isolation and productivity screening into a single step, resulting in dramatically shorter screening times and increased number of candidates.
The drug discovery landscape is shifting, with more scientists centering cell line development, disease models, and high-throughput screening methods around physiologically-relevant 3D cell models. The reason for this is clear: Using cellular model systems in research that closely mimic patient disease states or human organs can bring life-saving therapeutics to market – faster.
Antibody discovery typically refers to the screening and identification of monoclonal antibodies (mAbs) that target a specific epitope for the diagnosis and treatment of diseases. A common approach to generating monoclonal antibodies involves the fusion of a pre-mitotic cancer cell with a post-mitotic and terminal antibody-expressing B-cell from the spleen. The resulting fused cell is called a hybridoma and has the advantage of producing mAbs while dividing to regenerate itself. Screening hybridomas for binding specificity or productivity can be automated using the ClonePix 2 System.
Antibody discovery typically refers to the screening and identification of specific antibodies that target an antigen molecule for the diagnosis and treatment of diseases. The specificity of the antibody is based on its ability to bind the epitope, a unique region on the antigen molecule. Therapeutic antibodies are typically monoclonal, single cell-derived and target a unique epitope region on the antigen. The ClonePix 2 System automates screening and rapid detection of antigen-specific clones from a heterogenous population of cells.
Cell line development and assurance of monoclonality are critical steps in the process of generating biopharmaceutical molecules, such as monoclonal antibodies. A cell line can be established following the isolation of a single viable cell robustly expressing the protein of interest. A key milestone in this process is documenting evidence of clonality. Documentation of clonality is typically image-based, whereby an image of a single cell is produced and included in regulatory filings.
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Since its inception in 1975, the hybridoma technology revolutionized science and medicine, facilitating discoveries in almost any field from the laboratory to the clinic. Many technological advancements have been developed since then, to create these “magical bullets.” Phage and yeast display libraries expressing the variable heavy and light domains of antibodies, single B-cell cloning from immunized animals of different species including humans or in silico approaches, all have rendered a myriad of newly developed antibodies or improved design of existing ones. However, still the majority of these antibodies or their recombinant versions are from hybridoma origin, a preferred methodology that trespass species barriers, due to the preservation of the natural functions of immune cells in producing the humoral response: antigen specific immunoglobulins. Remarkably, this methodology can be reproduced in small laboratories without the need of sophisticate equipment. In this chapter, we will describe the most recent methods utilized by our Monoclonal Antibodies Core Facility at the University of Texas–M.D. Anderson Cancer Center. During the last 10 years, the methods, techniques, and expertise implemented in our core had generated more than 350 antibodies for various applications.
Screening and characterization of cell lines for stable production are critical tasks in identifying suitable recombinant cell lines for the manufacture of protein therapeutics. To aid this essential function we have developed a methodology for the selection of antibody expressing cells using fluorescence based ClonePix FL colony isolation and flow cytometry analysis following intracellular staining for immunoglobulin G (IgG). Our data show that characterization of cells by flow cytometry early in the clone selection process enables the identification of cell lines with the potential for high productivity and helps to eliminate unstable cell lines. We further demonstrate a correlation between specific productivity (qP) and intracellular heavy chain (HC) content with final productivity. The unique combination of screening using ClonePix FL and the flow cytometry approaches facilitated more efficient isolation of clonal cell lines with high productivity within a 15 week timeline and which can be applied across NS0 and CHO host platforms. Furthermore, in this study we describe the critical parameters for the ClonePix FL colony based selection and the associated calculations to provide an assessment of the probability of monoclonality of the resulting cell lines.
The Holy Grail sought by all Bioprocess Cell Line Development (CLD) groups is achieving high yields from easily-cultured, robustly-growing cells in timelines measured in weeks rather than months. As the first bottleneck in process development, CLD must first birth its product for upstream and downstream groups to initiate their own reproductive cycles. To facilitate shortened CLD timelines, scientists have turned to new technologies and automation platforms. Emerging high-throughput instrumentation such as Clonepix and Automated MicroBioreactors (AMBR) have been enthusiastically integrated into stable cell line generation platforms; however, application of these methodologies among users is divergent.
Therapeutic recombinant monoclonal antibodies (mAbs) are commonly produced by high-expressing, clonal, mammalian cells. Creation of these clones for manufacturing remains heavily reliant on stringent selection and gene amplification, which in turn can lead to genetic instability, variable expression, product heterogeneity and prolonged development timelines. Inclusion of cis-acting ubiquitous chromatin opening elements (UCOE™) in mammalian expression vectors has been shown to improve productivity and facilitate high-level gene expression irrespective of the chromosomal integration site without lengthy gene amplification protocols. In this study we have used high-throughput robotic clone selection in combination with UCOE™ containing expression vectors to develop a rapid, streamlined approach for early-stage cell line development and isolation of high-expressing clones for mAb production using Chinese hamster ovary (CHO) cells. Our results demonstrate that it is possible to go from transfection to stable clones in only 4 weeks, while achieving specific productivities exceeding 20 pg/cell/day. Furthermore, we have used this approach to quickly screen several process-crucial parameters including IgG subtype, enhancer-promoter combination and UCOE™ length. The use of UCOE™-containing vectors in combination with automated robotic selection provides a rapid method for the selection of stable, high-expressing clones.