ClonePix 2 – Mammalian Colony Picker

Cell Line Development

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.

Cell surface expression screening

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.

Clone productivity screening and titer

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.

Drug Discovery & Development

For every drug that makes it to the finish line, another nine don’t succeed. This alarming failure rate can be traced to reliance on 2D cell cultures that don’t closely mimic complex human biology, often leading to inaccurate predictions of a drug’s potential and extended drug development timelines.

Hybridoma screening

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 and the Octet HTX systems.

Monoclonal Antibody Discovery

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.

Monoclonality

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.