title: Human serum albumin from recombinant DNA technology: challenges and strategies.
abstract: BACKGROUND
  As the most abundant protein in the blood, human serum albumin (HSA) plays an important role in maintaining plasma oncotic pressure and fluid balance between the body's compartments. HSA is thus widely used in the clinic to treat diseases. However, the shortage of and safety issues arising from using plasma HSA (pHSA) underscore the importance of recombinant HSA (rHSA) as a promising substitute for pHSA.
  
  
  METHODS
  Here, we review the production of rHSA, from expression to downstream processing, and highlight the scalability and cost-effectiveness of the two main expression platforms. We also discuss the biosafety of commercially available pharmaceutical rHSA with respect to impurities and contaminants, followed by an analysis of recent progress in preclinical and clinical trials. We emphasise the challenges of producing pharmaceutical-grade rHSA.
  
  
  CONCLUSIONS
  rHSA can be highly expressed in various hosts and seems to be identical to pHSA. rHSA generated from yeast appears to be as efficient and safe as pHSA in a series of preclinical and clinical trials, whereas rHSA from rice seeds exhibits great potential for more cost-effective production. Cost-effective products with no adverse effects will likely play a vital role in future human therapeutics.
  
  
  CONCLUSIONS
  Our understanding of pharmaceutical-grade rHSA production has improved with respect to expression hosts, biochemical properties, downstream processing, and the detection and removal of impurities. However, due to the large dosages required for clinical applications, the production of sufficient quantities of rHSA still presents challenges. This article is part of a Special Issue entitled Serum Albumin.
authors: Engineering Research Center for Plant Biotechnology and Germplasm Utilization, Ministry of Education, Wuhan University, Wuhan 430072, China; State Key Laboratory of Hybrid Rice, College of Life Sciences, Wuhan University, Wuhan 430072, China.
authors: Zhen
authors: Z
authors: Chen
authors: Yang
authors: Y
authors: He
authors: Bo
authors: B
authors: Shi
authors: Daichang
authors: D
authors: Yang
mesh_terms: D000818:Animals; D030801:Animals, Genetically Modified; D002986:Clinical Trials as Topic; D004274:DNA, Recombinant / Q000235:genetics*; D006801:Humans; D030821:Plants, Genetically Modified; D011994:Recombinant Proteins / Q000096:biosynthesis / Q000235:genetics / Q000627:therapeutic use; D012709:Serum Albumin / Q000096:biosynthesis / Q000235:genetics* / Q000627:therapeutic use
chemical_list: D004274:DNA, Recombinant; D011994:Recombinant Proteins; D012709:Serum Albumin
keywords: OsrHSA; Plant bioreactor; Recombinant human serum albumin; rHSA biosafety; rHSA processing