CPI is in final stages of project to transform manufacture of biologics

The UK’s technology innovation provider for process manufacturing, the Centre for Process Innovation (CPI), has announced that it is in the final stages of a collaboration project with the University of Edinburgh’s Roslin Institute to transform the manufacture of biologics.

This collaborative project has been funded by the Biotechnology and Biological Sciences Research Council (BBSRC) and is being hosted at CPI’s National Biologics Manufacturing Centre. It is aimed at developing commercially viable and scalable methods to produce biologics in transgenic animals that will allow for the production of cost-efficient, highly pure, biologically active therapeutic proteins.

Therapeutic proteins are important as they can be used in the development of novel therapies for difficult to treat diseases, such as chronic diseases, immune disorders and cancers. However, these therapies can be expensive to produce as they are developed in cell culture bioreactors, which can be associated with several disadvantages such as low yield and solubility problems.

The Roslin Institute has been working on developing therapeutic proteins using genetically modified chickens that can express different recombinant proteins in their egg whites. A successful system that has been developed at lab scale has been a transgenic chicken expressing the CSF1-Fc protein in its egg white. CSF1-Fc is a protein that is present in all mammals which has the potential to naturally improve the immune system of pigs. For this to be commercially viable, however, it needs to be scalable.

In this collaborative project, the teams will purify a substantial amount of egg white containing the pig CSF1-Fc protein to evaluate the initial scalability of the protein and help form the basis of the purification process. It is hoped that they will be able to demonstrate an economically viable and scalable downstream process to isolate this therapeutic protein in egg whites. Positive results of this project will have wider implications for the development of both veterinary and human therapeutics, by providing a more efficient route for biologics manufacture in the future.

“The next stage will be for Roslin Technologies to commercialise this protein for the reagents market,” revealed Natasha Lethbridge, CPI.

“We wanted to work with CPI on this project because of the team’s biologics expertise, chromatography experience and the high quality of facilities available,” added Lissa Herron, The Roslin Institute. “CPI has been critical in developing our methods into a commercially scalable and viable process.”