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A collaboration between The Centre for Process Innovation and The Roslin Institute aims to develop commercially viable and scalable methods of producing biologics using transgenic animals.
The Centre for Process Innovation (CPI), the UK's technology innovation provider for process manufacturing, is in the final stages of a collaboration project with the University of Edinburgh's Roslin Institute to change the way that proteins are manufactured for research and veterinary and human health, CPI announced in a Feb. 1, 2018 press release.
The project is funded by the Biotechnology and Biological Sciences Research Council and is hosted at CPI's National Biologics Manufacturing Centre in Darlington, UK. The project aims to develop commercially viable and scalable methods of producing biologics in transgenic animals, which will enable the production of cost-efficient, pure, and biologically active therapeutic proteins, according to CPI.
Typically, therapeutic proteins are costly to produce using cell culture bioreactors, which can be expensive and are associated with disadvantages, including low yield and solubility problems, according to CPI. Consequently, alternative approaches, such as the use of natural biological systems, have been explored in recent years.
The Roslin Institute has a long-standing project to develop therapeutics proteins using genetically modified chickens that can express different recombinant proteins in egg whites. The use of a transgenic chicken to express in its egg white the CSF1-Fc protein, which is present in all mammals and has the potential to naturally improve the immune system of pigs for agricultural production, has been successfully developed at the lab scale. However, to make this protein commercially viable, the production process must be scalable.
The collaboration between The Roslin Institute and CPI will purify a substantial amount of egg white containing the pig CSF1-Fc protein to evaluate initial scalability and help form the basis of the purification process. They aim to demonstrate an economically viable and scalable downstream process to isolate the therapeutic protein in egg whites. Positive results in this project are expected to have wider implications for developing 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 commercialize this protein for the reagents market," said Natasha Lethbridge with CPI in the press release.
"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," Lissa Herron with The Roslin Institute added in the release. "CPI has been critical in developing our methods into a commercially scalable and viable process."