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Pichia production of albumin fusion proteins

 

Overview
The use of VTU´s well-established Pichia expression system facilitates high-yield production of albumins and proteins genetically fused to human serum albumin (HSA) using robust, reproducible and scalable processing methods.
The Pichia platform delivers unprecedented capabilities to produce albumin fusion proteins in commercial quantities for the increasing number of biopharma companies with HSA fusion proteins in their pipeline.
VTU´s Pichia pastoris toolbox allows HSA fusion proteins to be secreted very efficiently (5-20 g/L) resulting in reduced production costs at the same time increasing the profitability of a therapeutic product and maintaining quality.

Background
The pharmaceutical and biotech industry is increasingly involved in development of novel biopharmaceuticals and biobetters based on peptides and small proteins with an intrinsic need for half-life extension.
A proven strategy for extending the half-life of therapeutic proteins is fusion to human serum albumin, which is stable, benign and abundant. This fusion allows for less frequent administration while maintaining efficacy.
Albumin is a well characterized, naturally occurring carrier protein with a particularly long serum half-life, which does not elicit unwanted immunogenicity and, in contrast to other technologies, comes with a well-known mechanism of clearance.
Features
VTU´s Pichia pastoris platform is a high productivity system for the manufacture of recombinant albumins and albumin fusion proteins.
This technology has yielded titers of up to 35 g/L of recombinant albumins, thus constituting the highest values so far reported with respect to recombinant proteins being secreted into the culture supernatant of yeast cultivations.
The use of a special subset of VTU´s exclusive AOX1 promoter variants, enabling production processes without the need for induction with methanol, furnishes double-digit g/L levels of HSA in fermentations with glycerol as the sole carbon source.

Benefits
The suite of exclusive technologies making up VTU´s Pichia production platform stands out for its high-performance expression strains and corresponding processes enabling significantly more cost effective production of customer´s HSA fusion proteins.
Compared with alternative technologies, such as PEGylation, Pichia-produced recombinant albumin fusion requires no post-expression chemical modifications and hence fewer purification steps.
VTU Technology has successfully applied recombinant albumin fusion technology to various proteins and peptides. Albiglutide, a dimer of a recombinant glucagon-like peptide-1 variant fused to human albumin ((GLP-1)-(GLP-1)-HSA) has recently obtained US FDA (Tanzeum) and EMA (Eperzan) approvals. Various other proteins and peptides fused to HSA are in clinical and pre-clinical development.

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