Development of an In-House Cell Free Extract Process and Robotic Platform for Expression Optimisation

The advent of personalised medicine promises more efficacious treatments. However, moving away from a one size fits all’ model demands new, adaptable and complex manufacturing processes for the next generation of therapeutics. Cell Free Expression (CFE), a method that uncouples host cells from recombinant protein expression, may present a solution to this new manufacturing challenge.

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The advent of personalised medicine promises more efficacious treatments. However, moving away from a one size fits all’ model demands new, adaptable and complex manufacturing processes for the next generation of therapeutics. Cell Free Expression (CFE), a method that uncouples host cells from recombinant protein expression, may present a solution to this new manufacturing challenge.

Essentially, CFE is cellular protein synthesis, minus the cells. All the biological components required to produce a desired recombinant protein are extracted from host cells into a lysate. Once established, a lysate can be used to express multiple products within a few hours. This is compared to days or weeks with traditional cell-based production, which requires time-consuming and costly cloning steps. CFE reactions can also be linearly scaled and automated as required.

It is possible to imagine how CFE could be used for local manufacture of personalised medicines on-demand, as an alternative to the mass production of treatments with commercial processes. However, CFE protein yields suffer from a lack of standardised components, leading to reaction variability. In this study, Philip Probert and his team at CPI aimed to develop a scalable and robust E. coli lysate generation process and to use this as the basis of a high-throughput platform for optimisation of CFE.

Read the full article to learn more about how CFE can be optimised and scaled up to increase yields and meet the demands of agile, small batch manufacture.

View the full article on the American Pharmaceutical Review website.