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Application note: Rapidly isolate high-producing clones

Posted: 21 December 2018 | | No comments yet

Find out how to streamline Cell Line Development by identifying high-producing clones with monoclonality assurance in one day.

In the discovery and development of novel biopharmaceuticals (such as antibodies) for therapeutic use Cell Line Development is an integral process in the biomanufacturing of therapeutic proteins. Mammalian cells make ideal factories for protein production as they have similar molecular mechanisms to human cells for protein modifications such as glycosylation.

During the development of a mammalian cell line there are some desirable attributes as well as criteria specified by regulatory bodies (such as ICH, FDA, EMA) which state that cell lines for therapeutic use must be cloned from a single cell progenitor to ensure genetic and phenotypic consistency which require proof of monoclonality.

Five key characteristics desired from a host cell line are:

  1. Productivity
  2. Scalability
  3. Stability
  4. Quality
  5. Monoclonality

Being able to provide each of these characteristics from a cell line creates a substantial bottleneck when screening for and isolating rare cells. Traditionally, selection of single clones was achieved by the resource-intensive method of limiting dilution, and more recently aided by semi-automated technologies such as fluorescent activated cell sorting (FACS), colony picking and single-cell printers. Once isolated, clones are imaged by instruments such as cell-in-well imagers and then assessed for their productivity before being progressed into small scale bioreactors for batch production.

With the market demand for biotherapeutics increasing at a dramatic rate there is a pressing need to substantially shorten the development workflow. Cyto-Mine® utilises established picodroplet technology to fast-track the generation of cell banks comprised of high-producing clones derived from single cells with monoclonality assurance.

The present study illustrates the process by which the Cyto-Mine® IgG secretion assay measures the productivity of hundreds of thousands of single cells encapsulated in highly consistent picoliter droplets or ‘test tubes’ while simultaneously providing verification of clonality.

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