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STABILIZED FORMULATIONS CONTAINING ANTI-ANG2 ANTIBODIES
专利权人:
Regeneron Pharmaceuticals; Inc.
发明人:
申请号:
EP13702556.5
公开号:
EP2807190B1
申请日:
2013.01.22
申请国别(地区):
EP
年份:
2018
代理人:
摘要:
Pharmaceutical formulations comprising an Antibody that specifically binds to angiopoietin 2 (ang-2). The formulations may also contain an Antibody anti ang - 2, at least one amino acid, at least one carbohydrate, or at least a non-ionic surfactant.Pharmaceutical formulations Exhibit a substantial degree of stability of the Antibody after storage for several months, and after having been subjected to Thermal Stress and other physical effort.Claim 1: a Pharmaceutical formulation comprising: (i) an Antibody that specifically binds to human Angiopoietin 1 (Ang - 2 Human) (ii) a buffer At pH 6.0 (0.3 (iii) a nonionic Detergent and (iv) a Stabilizer.Claim 2: pharmaceutical formulation of claim 1, in which the Antibody comprises a hcdr1 of SEQ ID no. 4, a hcdr2 of SEQ ID no. 6, a hcdr3 of SEQ ID No. 8, a lcdr1 of SEQ ID no. 12, a lcdr2 of SEQ ID no. 14, and a lcdr3 of SEQ ID no. 16.Claim 3: pharmaceutical formulation of any of claims 1 and 2, in which the Antibody comprises a hcvd of SEQ ID no. 18 and a lcvd of SEQ ID no. 20. Claim 5: pharmaceutical formulation of any of claims 1 to 4, in which the concentration of Antibody is around 25 mg \/ ml (0.375 mg \/ ml, or around 50 mg \/ ml (7.5 mg \/ ml.Claim 32: a Pharmaceutical formulation comprising (a) 25 mg \/ ml (3.75 mg \/ ml of ang-2 Antibody anti histidine (b), 10 mm (1.5 mm, pH 6 (c) (0.3, 0.2% w \/ V + 0.03% Polysorbate 20, and (d) 10% w \/ V (1.5% sucrose,In which: (a) comprises a hcvd Antibody of SEQ ID no. 18 and a lcvd of SEQ ID no. 20 (b) more than 96% of the Antibodies have a Molecular Weight of 151 kDa (1 kDa (c) at least one 53 per cent of the Antibodies have an isoelectric Point of around 8,13 0,01 and (d) of around 9 0% to about 92% of the Antibodies are fucosylated.
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