Human serum albumin (HSA) has traditionally been obtained by the fractionation of blood plasma using the Cohn process developed during World War II. The HSA is purified, concentrated, and treated to reduce viral or bacterial contamination. Plasma-derived HSA is often used in emergency and surgical settings to restore and maintain the circulating blood volume in patients who have experienced shock due to burns, trauma, or surgery. However, it’s challenging to guarantee complete viral inactivation or removal due to the inherent complexities and variabilities in biological systems and manufacturing processes. To overcome this inherent problem with plasma-derived albumin, biotechnology advances developed recombinant DNA technology to introduce the human albumin gene into the DNA of a host organism, such as yeast, bacteria or mammalian cells. These are then grown to produce ‘recombinant albumin’ in a bioreactor, which is usually a stainless steel fermenter that provides a sterile, controlled environment to maximise albumin production. The highest quality recombinant albumin from baker’s yeast (Saccharomyces cerevisiae) is currently the monograph standard recombinant albumin in the United States Pharmacopeia-National Formulary (USP-NF), which is completely free of animal-derived components and has exactly the same protein sequence compared to albumin from human-plasma.
You can read more about Recombinant Albumin here.
