Process for producing a plasma protein-containing medicament

Details Process for producing a plasma protein-containing medicament Process for producing a plasma protein-containing medicament

A - Human Necessities

61

K

A61K 38/38 (2006.01) A61K 35/16 (2006.01) A61K 38/17 (2006.01) A61K 38/36 (2006.01) A61K 39/395 (2006.01) A61K 47/12 (2006.01) C07K 14/76 (2006.01) C07K 16/06 (2006.01) A61K 38/00 (2006.01)

Patent

CA 2265936

There is disclosed a method of preparing a plasma-protein--containing medicament from citrated plasma or from a citrate--containing plasma fraction, the medicament being substantially free from undesired metals, which method comprises the following steps: - exchanging the citrate and optionally citrate-bound metals in a plasma-protein-containing solution for a water-soluble mono- or dicarboxylate or for an organic mono- or dicarboxylic acid under non-precipitating conditions, - recovering the plasma protein or the plasma proteins, and - finishing the medicament.

L'invention décrit un procédé de production d'un médicament, contenant une (ou plusieurs) protéine(s) plasmatiques(s) et fondamentalement exempt de métaux indésirables, à partir de plasma de citrate ou d'une fraction plasmatique contenant du citrate. Ce procédé comprend les étapes suivantes: on remplace le citrate et éventuellement les métaux liés au citrate dans une solution renfermant une (ou plusieurs) protéine(s) plasmatique(s) par un mono ou dicarboxylate soluble dans l'eau ou un acide mono- ou dicarboxylique dans des conditions de non précipitation, on isole la ou les protéine(s) plasmatique(s) et on produit le médicament.

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