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.

Product Specifications

Characteristics Analytical method Albumedix specification
Appearance Visual Inspection Clear, pale straw/amber colored solution
Assay – Albumin Content (Purity) USP-NF (Native PAGE) ≥ 99.0%
Assay – Total Protein USP-NF (Kjeldahl) ≥ 95 g.L-1
Sodium USP-NF (AA) 200 – 300 mM
Impurities – Host Cell Proteins In-house (Yeast Antigen ELISA) For Information Only (ng/g rAlbumin Human)
pH (1% w/v) USP <791> 6.0 – 7.0
Bacterial Endotoxins USP <85> ≤ 0.01 EU/mg of rAlbumin Human
Mass Analysis USP-NF Theoretical Mass ± 20 Da (66418 to 66458)
Impurities – High Molecular Weight Proteins USP-NF ≤ 1.0% (w/w) rHA
Octanoate In-house (GC) ≤ 1 mM
Bioburden In-house (Membrane Filtration) ≤ 10 cfu/mL