Baker’s yeast, Saccharomyces cerevisiae, has been used safely for decades in the manufacture of recombinant biologics, including insulins and albumin. The production strains used for recombinant albumin production comprise only natural yeast DNA plus a synthetic gene for human albumin. When grown in special bioreactors in a biopharmaceutical manufacturing facility, they secrete recombinant albumin into the culture media from where it can easily be recovered. The yeast cells are grown in a simple defined culture media containing sugar, salt and vitamins. The whole process is designed to be compliant with good manufacturing practices (cGMP) and only uses animal-free ingredients, which means the albumin produced can also be halal compliant. Because baker’s yeast has been used by humans for millennia and naturally contains no pathogenic lytic viruses or prion proteins, it is an extremely safe starting point for the manufacture of biopharmaceutic proteins, including albumin. The recombinant albumin secreted from the cells is very high quality, partly because there are few proteins and chemicals present in the culture media which can modify or damage it, but also because it is easily separated from the cells and purified to a high level to remove other components from the media and process. The purified recombinant albumin is then concentrated and formulated using ultra-pure water for injection as a final product.
Read more about recombinant albumin here.
