Recombinant DNA expression in Saccharomyces cerevisiae produces Albumedix™ Recombumin® Elite.
As the world leader in recombinant human albumin (rAlb), Albumedix have developed a portfolio of rAlb products collectively known as Recombumin®. Manufactured from their proprietary Saccharomyces yeast strains, at ICH Q7 cGMP standards, Recombumin is the highest quality animal origin-free rAlb product commercially available. Internationally recognized by the leading regulatory authorities, Recombumin is the first and only rAlb product used in the manufacture of approved biopharmaceuticals and medical devices (Pipeline).
These rAlb products have been specifically designed to overcome physical and chemical stress of biopharmaceuticals, which cannot be addressed by conventional excipients.
||Clear, pale straw/amber colored solution
|Assay – Albumin Content (Purity)
||USP-NF (Native PAGE)
|Assay – Total Protein
||≥ 95 g.L-1
||200 – 300 mM
|Impurities – Host Cell Proteins
||In-house (Yeast Antigen ELISA)
||For Information Only (ng/g rAlbumin Human)
|pH (1% w/v)
||6.0 – 7.0
||≤ 0.01 EU/mg of rAlbumin Human
||Theoretical Mass ± 20 Da (66418 to 66458)
|Impurities – High Molecular Weight Proteins
||≤ 1.0% (w/w) rHA
||≤ 1 mM
||In-house (Membrane Filtration)
||≤ 10 cfu/mL