Cell screening for biopharmaceuticals

Pharmaceutical production of therapeutic reagents can employ living cells that secrete recombinant proteins or monoclonal antibodies. This process requires careful selection of the cells that secrete sustained protein levels of high quality. Identifying cell lines that stably produce high-protein titres is a critical part of biopharmaceutical development, posing a major bottleneck in the field.

The EU-funded 'Development of a rapid cellular characterisation technology for use in the biopharmaceutical industry' (PM-CELL) project developed a technology for rapid cell line characterisation. The idea was to design a system that could be used to predict optimum cell performance in various industrially relevant bioprocesses.

Project members developed a modelling approach using chemical-specific growth response as an input. The developed model predicted whether clones were good or bad growers with 85 % accuracy. Cell growth response 'fingerprints' were highly characteristic for particular cell lines. Fingerprints initially identified clones with 100 % accuracy, 2 passages later with 100 % accuracy and 4 passages later with 89 % accuracy.

PM-CELL resulted in a technology for rapid generation of a growth and productivity fingerprint. Now, scientists can accurately predict batch cell growth and maximum titre. Developed technology can compete with traditional, small-scale bioreactors and genetic identification of cell lines. Development of rapid and cost-saving screening assays for the biopharmaceutical industry resulted in three patent applications.

The impact of PM-CELL is expected to be multifold. Characterisation and selection of highly productive cell lines is a critical step for efficient industrial manufacturing processes. The developed technology can accelerate cell selection time by nearly 33 %. Allowing rapid translation of research to efficient drug production will be beneficial for human health care.