Processes for the purification of human recombinant decorin...

C - Chemistry – Metallurgy – 07 – K

Patent

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Details

C07K 14/47 (2006.01) C07K 1/18 (2006.01) C07K 1/20 (2006.01) G01N 27/04 (2006.01) G01N 27/06 (2006.01) G01N 33/53 (2006.01) G01N 33/68 (2006.01)

Patent

CA 2194566

The present invention is directed to a process for the production of substantially pure human recombinant decorin which involves the combination of three separate stages characterized by contacting decorin-containing cell culture medium with (1) a first strong anionic exchange resin; then with (2) a hydrophobic interactive chromatographic resin; and finally with (3) a second strong anionic exchange resin. By using a combination of steps, and certain reagents, in particular a 2.4 to 3 molar GuHCl solution to elute decorin from a hydrophobic interactive column, the process of this invention provides a more convenient and reproducible process for purifying human recombinant decorin. The invention also provides a process for detecting the presence of guanidinium ions in a sample solution.

L'invention concerne un procédé de production de décorine humaine recombinée sensiblement pure, qui consiste en la combinaison de trois étapes séparées et caractérisées par la mise en contact d'un milieu de culture de cellules contenant de la décorine avec (1) une première résine forte échangeuse d'anions, puis (2) avec une résine chromatographique interactive et hydrophobe et enfin (3) avec une deuxième résine forte échangeuse d'anions. La mise en application de cette combinaison d'étapes, ainsi que de certains réactifs, en particulier une solution de 2,4 à 3 moles de GuHCl servant à éluer la décorine à partir d'une colonne interactive hydrophobe, permet d'obtenir un procédé plus approprié et plus reproductible, afin de purifier la décorine humaine recombinée. L'invention concerne également un procédé de détection de la présence d'ions guanidinium dans une solution échantillon.

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