Recombinant protein expression is the keystone manufacturing technique supporting the production of many biological therapies. Many protein expression systems exist, but most biological drugs approved for clinical use are made by mammalian cell hosts. These manufacturing processes are frequently laborious, slow, and expensive.
Yeast systems offer a significantly more straightforward way of expressing recombinant proteins at scale than mammalian cell culture, often at a much lower cost.
Several yeast protein expression systems have been commercialised. However, the baker's yeast (Saccharomyces cerevisiae) expression systems, which are most commonly used in industry for biologics production, have never themselves been widely commercialised by the companies that developed them. The patent protection for these baker's yeast systems has now expired or is expiring. This engenders considerable freedom to create new systems and develop new IP surrounding enhanced, second-generation protein expression systems using S. cerevisiae as their protein-production powerhouse and making this technology widely available to new companies bringing recombinant products to the market.
This project will enable Phenotypeca to develop novel strains of S. cerevisiae that can quickly and easily be tailored to optimise production of recombinant proteins.
In this instance, the platform will be exemplified by producing a protein (H Guard) for another UK SME, Invizius. This protein is used as a coating on dialysis equipment to prevent inflammatory responses induced by repeated exposure to dialyser membranes.
Invizius will work alongside the Centre for Process Innovation (CPI). The latter join the consortium as a grant-funded partner to conduct industrial fermentation modelling to identify the most suitable process for scale-up production.
The project supports Phenotypeca to become a service provider for clients wanting S. cerevisiae-based protein expression systems.
Phenotypeca is attempting to overcome the unmet market need for S. cerevisiae protein expression systems, especially for a class of therapeutic peptides where Pichia pastoris-based yeast systems cannot meet the quality and regulatory requirements.