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Antibody and Protein formulations
专利权人:
BAYER HEALTHCARE LLC
发明人:
XINGHANG MA,JUN XIANG
申请号:
ARP130103085
公开号:
AR092388A1
申请日:
2013.08.29
申请国别(地区):
AR
年份:
2015
代理人:
摘要:
Claim 1: a formulation of a Salt free Protein or Antibody, characterized in that it comprises: a) 10 mm to 30 mm histidine; b) 50 ppm to 200 ppm of a nonionic Surfactant; (c) 88 mm to 292 mm sugar or a Sugar alcohol selected from mannitol, glucose, dextrose,Trehalose and sucrose; (d) 0 mm to 50 mm arginine and lysine) 0 mm to 50 mm; (f) 0 mm to 133 mm Glycine or alanine; (g) 0 mm to 10 mm methionine; and (H) 1 mg / ml and 150 mg / ml of Protein or Antibody; where such Formulation Protein or Antibody has a pH range from pH 4.0 to 6.0 pH and dic Formulation of Protein has substantially contains no inorganic Salt.Claim 2: the formulation of a Salt free Protein or Antibody of claim 1, wherein Said is a Polysorbate nonionic Surfactant selected from Polysorbate 20 and Polysorbate 80.Claim 17: a formulation of Free TFPI Antibody anti Salt, characterized in that it comprises: a) 10 mm to 30 mm histidine, (b) 50 ppm to 200 ppm of a nonionic Surfactant, (c) 88 mm to 292 mm sugar or a Sugar alcohol selected from mannitol, Trehalose and Glucose, dextrose, Sucrose, d) 0 mm to 50 mm arginine and lysine) 0 mm to 50 mm, f) 0 mm Glycine alanita A133 mm or,(g) 0 mm to 10 mm methionine, and H) 1 mg / ml and 150 mg / ml Antibody anti TFPI; where such anti TFPI Antibody formulation has a pH in the PH Range 4.0 to 6.0 and PH where the formulation of Antibody anti tpfi substantially contains no inorganic Salt.Claim 23: the formulation of Free TFPI Antibody anti Salt of claim 17, wherein Said anti TFPI Antibody is a monoclonal antibody igg u2082 Human.Claim 24: the formulation of Free TFPI Antibody anti Salt of claim 17, wherein Said human monoclonal antibody igg u2082 comprises a light chain comprising the Amino Acid Sequence SEQ ID no. 1 and a heavy chain that includes the sequence of am Ino u00e1cidos of SEQ ID no. 2.Claim 25: a method for the treatment of a disorder in a patient, wherein Said method comprises administering to the patient a therapeutically effective amount of a form
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