Well Characterized Biologicals, IBC
Meet up with Albumedix at the 2017 Well Characterized Biologicals, IBC
Below you will find answers to some of the questions we get asked the most about our Recombumin® recombinant human albumin products. If you have other questions, please get in touch with our experts.
Recombumin® is a recombinant version of human serum albumin used in the development of drug, vaccine, cell therapy and device products.
What is recombinant albumin?
Albumin is a well-described carrier protein present in high concentrations (40–50 g/L) in plasma with a circulatory half-life of approximately 19 days. Its high concentration in plasma and interstitial space has a major influence on the oncotic control of body fluids leading to its use for decades as a plasma volume expander. It is manufactured in hundreds of metric tons worldwide for this purpose. Due to its historic availability, albumin is widely used in the manufacture of drug, vaccine, and device products for a range of applications such as formulation, drug delivery, and medical device coating.
Traditionally, albumin has been sourced from human or bovine serum. Due to regulatory concerns over blood-borne contaminants (mycoplasma, viruses, and prions), reliability of supply, and the performance variability of the product, there is an increased demand for a more defined animal origin-free replacement in the biopharmaceutical industry. As a result, Albumedix has developed a range of high-quality, animal origin-free recombinant human albumins from a proprietary Saccharomyces yeast strain. With 30 years’ experience and multiple manufacturing sites, the secure supply of safe and consistent albumin material can be ensured.
What does recombinant albumin do?
With wide-ranging applications in the areas such as formulation, drug delivery and vaccine processing, recombinant albumin offers a variety of functions. These include protein stabilization (aggregation prevention), adsorption and oxidation prevention of biological drugs and vaccines.
Where does recombinant albumin come from?
To provide a safer alternative to traditional sources of albumin, Albumedix has developed its range of high-quality, animal origin-free recombinant albumins from a proprietary Saccharomyces yeast strain. As a result, no animal- or human-derived materials are handled at the Albumedix facility for Recombumin® manufacture. All fermentation media, purification and formulation solutions used to make Recombumin® are prepared without the use of any animal-derived materials.