Yeast-Derived Recombinant Human Albumin (Recombumin^TM)

Introduction

An increasing number of blood proteins that were formerly only available as plasma-derived products are now becoming available as recombinant products. Such recombinant blood protein products have a number of potential advantages over their plasma-derived counterpart. With the potential for more control over the starting material, it is possible to produce a more homogeneous product and may be easier to ensure lot-to-lot consistency. The recombinant nature of the production systems generally requires that the purification of the product be more extensive, leading to a purer product. A major issue with regard to plasma-derived products is concern regarding the possibility of transmission of viruses or prions. Since mammalian cell lines are often used for production of recombinant blood proteins, there may be similar concerns regarding retroviruses; an even higher level of concern surrounds transgenically-produced blood proteins. However, such safety concerns are eliminated by the use of bacterial or yeast expression systems as there have been no reports of transmission of prokaryotic or lower eukaryotic viruses to animals.

Examples of recombinant blood products on the market or in development are coagulation factors such as Factor VIII, Factor VII and Factor IX, and protease inhibitors such as antithrombin III and α1 protease inhibitor. This paper summarises the development of a yeast-derived recombinant human albumin product (Recombumin^TM) by Delta Biotechnology Ltd., a subsidiary of Centeon LLC.

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