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.