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Mammalian cells are ideal for incorporating typical eukaryotic post-translation modifications, such as glycosylation (Demain and Vaishnav 2009; Walsh 2010b; Berlec and Strukelj 2013); however, the culture of mammalian cells is relatively slow, requires complex media, and is vulnerable to viral contaminations.As unicellular eukaryotic microbial host cells, yeast offers unique advantages in biopharmaceutical protein production.
The estimated market value of biopharmaceuticals, including recombinant therapeutic proteins, nucleic acid-based products, and engineered cell-based products, is , and mammalian cells are the most widely used host systems for biopharmaceutical protein production, accounting for 15%, 31%, and 43% of biopharmaceutical products developed, respectively (Berlec and Strukelj 2013).
The main strength of often results in inclusion body formation and/or low specific yields.
For example, synthetic promoter libraries have been created through the application of randomized oligonucleotides (Jeppsson ., 2011).
Such diverse sets of constitutive promoters with varied activities and sequences will facilitate the investigation of optimal expression levels of heterologous genes in constructing yeast host strains with heterologous biosynthesis pathway, such as the humanized glycosylation pathway.
The recombinant hepatitis B vaccine produced in the nonconventional yeast -produced hepatitis B virus S antigen (Hbs Ag) was found to be assembled into yeast-derived lipid membranes.
Previous studies have indicated that this lipoprotein particle structure is essential for the antigenicity of the HBs Ag (Rutgers was approved by the FDA in 2009, and several others are undergoing evaluation in clinical trials (Walsh 2010a).
These tools can target different levels in biosynthetic processes and allow multilevel modifications of yeast host strains to improve the quality and yield of recombinant proteins.
Efficient transcription is a critical step in controlling gene expression at the initial stage.
Furthermore, novel methods and tools in synthetic biology are under active development to facilitate rapid and efficient engineering of yeast by rational design, based on the information obtained from systems-level analyses.
Thus, synthetic biology approaches are expected to accelerate the construction of ‘yeast factories’ designed for the production of recombinant proteins with improved yield and quality (Vogl ., 2013).