STABLE PREPARATION OF RECOMBINANT FACTOR VIII WITHOUT ALBUMIN THAT HAS A LOW SUGAR CONTENT.

摘要

A STABILIZED FORMULATION OF RECOMBINANT FACTOR VIII (RFVIII) IS PRESENT, FREE OF ALBUMINE, IN LYOPHILIZED FORM, WHICH HAS AMORPHOUS AND CRYSTALLINE COMPONENTS, AND INCLUDES, WHEN RECONSTITUTED IN WATER, APPROX. BETWEEN 65 AND 400 MM OF GLYCINE, UP TO 50 MM OF HISTIDINE, BETWEEN 15 AND 60 MM OF SUCROSA, UP TO 50 MM OF NACL, UP TO 5 MM OF CACL {SUB, 2}, AND BETWEEN 50 AND 1500 IU / ML OF RFVIII. AN ESPECIALLY PREFERRED FORMULATION INCLUDES AFTER RECONSTITUTION WITH WATER, APPROX. 290 MM OF GLYCINE, 20 MM OF HISTIDINE, 30 MM OF SUCROSA, 30 MM OF NACL, 2.5 MM OF CACL {SUB, 2} AND BETWEEN 50 AND 1500 IU / ML OF RFVIII. THE RESIDUAL WATER CONTENT OF THE LYOPHILIZED PREPARATION IS APPROX. BETWEEN 1 AND 3% BY WEIGHT, PREFERABLY APPROX. 1% BY WEIGHT.