Process for manufacture of nematode-extracted anticoagulant...

C - Chemistry – Metallurgy – 12 – P

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C12P 21/02 (2006.01) A61K 38/17 (2006.01) C07K 14/435 (2006.01)

Patent

CA 2525831

The present invention provides a process for manufacture of purified Nematode- extracted Anticoagulant Proteins (NAPS), wherein the NAP manufactured by the claimed process method is a NAP drug substance that can be formulated as a NAP drug product. The present invention provides NAP drug substances and NAP drug products manufactured by the process disclosed herein. In one embodiment, the present invention provides a process for manufacture of rNAPc2/proline drug substance and rNAPc2/proline drug product, and provides rNAPc2/proline drug substance manufactured by the process disclosed herein.

La présente invention concerne une méthode de production de protéines anticoagulantes purifiées extraites du nématode (NAPS). La NAP produite par cette méthode est une substance pharmaceutique NAP pouvant être formulée comme produit médicamenteux NAP. L'invention concerne également des substances pharmaceutiques NAP et des produits médicamenteux NAP fabriqués par le procédé de l'invention. Dans un mode de réalisation, on décrit une méthode de production d'une substance pharmaceutique à base de rNAPc2/proline et d'un produit médicamenteux à base de rNAPc2/proline. L'invention concerne en outre une substance pharmaceutique à base de rNAPc2/proline produite par le procédé de l'invention.

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