DEFINITION

Recombinant Albumin Human (rAlbumin Human or rHA) is produced by recombinant DNA expression in Saccharomyces cerevisiae. Structural equivalence (primary, secondary, and tertiary) between rHA and human serum albumin (HSA) has been demonstrated. It consists of three domains composed of 585 amino acids containing a single tryptophan (Trp₂₁₄), one free thiol (Cys₃₄), and 17 disulfide bridges. It is presented as a sterile and nonpyrogenic aqueous liquid consisting of a 10% (w/v) or 20% (w/v) solution in Water for Injection. No human- or animal-derived raw material is involved in its manufacture. It contains NLT 95% and NMT 105% of the labeled amount and NLT 99% of its total protein is albumin. It contains no added antimicrobial agents, but it may contain appropriate stabilizing agents. The presence of process-related impurities, host cell DNA, and host cell proteins is process specific; suitable limits should be determined by appropriately validated methods. However, the limit for host cell proteins should be NMT 0.15 µg/g.