Albumin purification from human placenta

Albumin is the human protein used mainly for therapeutic purposes. Besides the traditionally used plasma, blood from placenta. is an alternative sourc e for albumin purification. We describe here an industrial process for puri fication of albumin from human placenta. The proposed albumin-purification process, for 50 kg of placentas, comprises: (i) extraction of haemolysed bl ood with saline and solid/liquid separation by basket centrifugation; (ii) selective precipitation of haemoglobin by ethanol/chloroform and precipitat e removal by filtration in a press filter; (iii) concentration/diafiltratio n of the filtrate in a 30 kDa cross-flow ultrafiltration (CFUF) membrane; ( iv) thermo-coagulation at 70 degrees C with sodium octanoate/EDTA; (v) trea tment with activated charcoal at pH 3; (vi) concentration/ diafiltration of the filtrate in a 30 kDa CFUF membrane; (vii) anion-exchange chromatograph y Q-Sepharose; (viii) hydrophobic-interaction chromatography with phenyl-Se pharose; and (ix) conditioning and pasteurization. The process yields an av erage of 4.5 g of albumin/kg of placenta with a purity of 97.1 % and A(403) of 0.05 (1 % protein). The final product passes pyrogen and toxicity tests in vivo and it does not contain polymers or aggregates, even after the acc elerated stability test, as judged by gel filtration, as required by the Br azilian Pharmacopoeia.