Homogeneous dimeric m-csf and storage stable formulations...

Details Homogeneous dimeric m-csf and storage stable formulations... Homogeneous dimeric m-csf and storage stable formulations...

A - Human Necessities

61

K

167/162, 167/103

A61K 38/19 (2006.01) A61K 9/19 (2006.01) A61K 47/34 (2006.01) C07K 14/53 (2006.01) A61K 38/00 (2006.01)

Patent

CA 1340269

Homogeneous dimeric macrophage colony stimulating factor (M-CSF), a regulatory, therapeutic glycoprotein, and storage stable formulations thereof, that are free of high molecular weight species (multimeric molecular aggregates) and stable to prolonged storage, pH affects, solvent effects and lyophilization, thereby retaining activity and therapeutic efficacy and relieving risk of potential side effects, are obtained from partially purified crude preparations by gel filtration chromatography. Homogeneous dimeric M-CSF is characterized by a single peak when assayed by gel filtration chromatography using a gel filtration matrix having a fractionation range (molecular weight) of about 10-1,500 kD.

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