Is recombinant albumin from yeast safe?

Recombinant human albumin (rHA) from baker’s yeast, Saccharomyces cerevisiae, is the safest form of albumin available today. It is an animal-free recombinant albumin with no risk of contamination by  pathogenic viruses or prion proteins, and no theoretical contamination from emerging pathogens. rHA from baker’s yeast has been used to define the ‘monograph standard’ in the United States Pharmacopeia-National Formulary (USP-NF) and has been used safely for many years in childhood vaccines and other medical products. In contrast to rHA from rice and Pichia sources, rHA from baker’s yeast lacks potentially immunogenic unnatural post-translational modifications, and batch-to-batch consistency concerns Frahm et al. 2014. Recombinant albumin from baker’s yeast has been shown to be structurally equivalent to human serum albumin (HSA) derived from blood donors and proven in Phase I clinical testing. Bosse et al., 2005 used doses up to 50 grams and multiple dosing regimes without any serious or potentially allergic events being reported when comparing the safety, tolerability, and pharmacokinetics/pharmacodynamics of rHA from baker’s yeast with HSA.