JPWO2019023564A5 - - Google Patents
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- JPWO2019023564A5 JPWO2019023564A5 JP2020503739A JP2020503739A JPWO2019023564A5 JP WO2019023564 A5 JPWO2019023564 A5 JP WO2019023564A5 JP 2020503739 A JP2020503739 A JP 2020503739A JP 2020503739 A JP2020503739 A JP 2020503739A JP WO2019023564 A5 JPWO2019023564 A5 JP WO2019023564A5
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- 239000007864 aqueous solution Substances 0.000 claims 23
- 102000004965 antibodies Human genes 0.000 claims 21
- 108090001123 antibodies Proteins 0.000 claims 21
- 125000003275 alpha amino acid group Chemical group 0.000 claims 20
- 239000000243 solution Substances 0.000 claims 8
- 239000004475 Arginine Substances 0.000 claims 5
- CZMRCDWAGMRECN-UGDNZRGBSA-N D-sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 claims 5
- CZMRCDWAGMRECN-GDQSFJPYSA-N Sucrose Natural products O([C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@H](CO)O1)[C@@]1(CO)[C@H](O)[C@@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-GDQSFJPYSA-N 0.000 claims 5
- 239000008363 phosphate buffer Substances 0.000 claims 5
- 239000005720 sucrose Substances 0.000 claims 5
- 102100014838 FCGRT Human genes 0.000 claims 2
- FFEARJCKVFRZRR-BYPYZUCNSA-N L-methionine Chemical compound CSCC[C@H](N)C(O)=O FFEARJCKVFRZRR-BYPYZUCNSA-N 0.000 claims 2
- 229940068968 Polysorbate 80 Drugs 0.000 claims 2
- 238000000502 dialysis Methods 0.000 claims 2
- 238000001914 filtration Methods 0.000 claims 2
- 235000010482 polyoxyethylene sorbitan monooleate Nutrition 0.000 claims 2
- 239000000244 polyoxyethylene sorbitan monooleate Substances 0.000 claims 2
- 229920001184 polypeptide Polymers 0.000 claims 2
- 229920000053 polysorbate 80 Polymers 0.000 claims 2
- 238000002360 preparation method Methods 0.000 claims 2
- 238000003998 size exclusion chromatography high performance liquid chromatography Methods 0.000 claims 2
- 239000004094 surface-active agent Substances 0.000 claims 2
- 229960001230 Asparagine Drugs 0.000 claims 1
- 101710003435 FCGRT Proteins 0.000 claims 1
- DCXYFEDJOCDNAF-REOHCLBHSA-N L-asparagine Chemical compound OC(=O)[C@@H](N)CC(N)=O DCXYFEDJOCDNAF-REOHCLBHSA-N 0.000 claims 1
- 235000001014 amino acid Nutrition 0.000 claims 1
- 150000001413 amino acids Chemical class 0.000 claims 1
- 235000009582 asparagine Nutrition 0.000 claims 1
- 230000000875 corresponding Effects 0.000 claims 1
- 230000000694 effects Effects 0.000 claims 1
- 238000009472 formulation Methods 0.000 claims 1
- 238000001990 intravenous administration Methods 0.000 claims 1
- 239000000203 mixture Substances 0.000 claims 1
- 239000000178 monomer Substances 0.000 claims 1
- 108010068617 neonatal Fc receptor Proteins 0.000 claims 1
- 238000007920 subcutaneous administration Methods 0.000 claims 1
- 238000006467 substitution reaction Methods 0.000 claims 1
- 230000001225 therapeutic Effects 0.000 claims 1
Claims (17)
- 安定的水溶液であって、
(a)約100mg/mLの濃度の抗C5抗体であって、配列番号19に記載されるアミノ酸配列を含む重鎖CDR1、配列番号18に記載されるアミノ酸配列を含む重鎖CDR2、配列番号3に記載されるアミノ酸配列を含む重鎖CDR3、配列番号4に記載されるアミノ酸配列を含む軽鎖CDR1、配列番号5に記載されるアミノ酸配列を含む軽鎖CDR2、および配列番号6に記載されるアミノ酸配列を含む軽鎖CDR3、を含む抗C5抗体、
(b)約50mMのリン酸緩衝液、
(c)約5%のスクロース、および
(d)約25mMのアルギニンを含む、安定的水溶液。 - 安定的水溶液であって、
(a)抗C5抗体であって、配列番号19に記載されるアミノ酸配列を含む重鎖CDR1、配列番号18に記載されるアミノ酸配列を含む重鎖CDR2、配列番号3に記載されるアミノ酸配列を含む重鎖CDR3、配列番号4に記載されるアミノ酸配列を含む軽鎖CDR1、配列番号5に記載されるアミノ酸配列を含む軽鎖CDR2、および配列番号6に記載されるアミノ酸配列を含む軽鎖CDR3、を含む抗C5抗体、
(b)約50mMのリン酸緩衝液、
(c)約5%のスクロース、
(d)約0.05%のポリソルベート80、および
(e)約25mMのアルギニンを含む、安定的水溶液。 - 界面活性剤をさらに含む、請求項1に記載の安定的水溶液。
- 前記界面活性剤が、約0.05%のポリソルベート80である、請求項3に記載の安定的水溶液。
- 前記抗C5抗体が、約100mg/mLの濃度である、請求項2に記載の安定的水溶液。
- 前記抗C5抗体が、ヒト新生児型Fc受容体(FcRn)に結合するバリアントヒトFc定常領域をさらに含み、前記バリアントヒトFc CH3定常領域は、各々EUナンバリングで、天然型ヒトIgG Fc定常領域のメチオニン428およびアスパラギン434に対応する残基に、Met-429-LeuおよびAsn-435-Serの置換を含む、請求項1または2に記載の安定的水溶液。
- 前記抗C5抗体が、配列番号12に記載される重鎖可変領域と、配列番号8に記載される軽鎖可変領域を含む、請求項1または2に記載の安定的水溶液。
- 前記抗C5抗体が、配列番号13に記載される重鎖定常領域を含む、請求項1または2に記載の安定的水溶液。
- 前記抗C5抗体が、配列番号14に記載されるアミノ酸配列を含む重鎖ポリペプチドと、配列番号11に記載されるアミノ酸配列を含む軽鎖ポリペプチドを含む、請求項1または2に記載の安定的水溶液。
- 前記抗C5抗体が、ALXN1210(ラブリズマブ)である、請求項1または2に記載の安定的水溶液。
- 前記溶液のpHが、7.2~7.6である、請求項1または2に記載の安定的水溶液。
- 前記溶液のpHが、7.4である、請求項11に記載の安定的水溶液。
- 前記溶液が、滅菌されている、請求項1または2に記載の安定的水溶液。
- (a)前記抗C5抗体が、少なくとも6カ月間、2℃~8℃で保存中、SEC-HPLCにより決定されたときに少なくとも97%の単量体を維持している;
(b)前記溶液中、前記抗C5抗体の3%未満が、SEC-HPLCにより決定されたときに凝集している;および/または
(c)少なくとも6カ月間、2℃~8℃で保存中、前記抗C5抗体が、保存前の前記抗C5抗体と比較して、そのC5結合活性を少なくとも90%維持している、
請求項1または2に記載の安定的水溶液。 - 前記溶液が、皮下投与または静脈内投与に適している、請求項1または2に記載の安定的水溶液。
- 100mg/mLの濃度の、配列番号23に記載されるアミノ酸配列を含む重鎖CDR1、配列番号19に記載されるアミノ酸配列を含む重鎖CDR2、配列番号3に記載されるアミノ酸配列を含む重鎖CDR3、配列番号4に記載されるアミノ酸配列を含む軽鎖CDR1、配列番号5に記載されるアミノ酸配列を含む軽鎖CDR2、および配列番号6に記載されるアミノ酸配列を含む軽鎖CDR3を含む抗C5抗体、50mMのリン酸緩衝剤、5%のスクロース、および25mMのアルギニンを含む、安定的な濃縮抗体溶液を作製する方法であって、
i)前記抗C5抗体を含む第一の水溶液を提供することであって、前記第一の水溶液は、第一の製剤を有し、10mg/mL以下の前記抗C5抗体を含む、提供することと、
ii)前記第一の水溶液に、pH7.4で50mMのリン酸緩衝剤、5%のスクロース、および25mMのアルギニンを含む製剤への透析ろ過を行い、それにより第二の水溶液を作製することであって、前記第二の水溶液は、前記透析ろ過の結果として第二の製剤を有する、行うことと、
iii)前記第二の水溶液を濃縮し、100mg/mLの抗C5抗体、50mMのリン酸緩衝剤、5%のスクロースおよび25mMのアルギニンを含む安定的な濃縮抗体溶液を作製することと、を含む、方法。 - 請求項1に記載の前記安定的水溶液を含む治療用キット。
Priority Applications (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
JP2022083775A JP7277649B2 (ja) | 2017-07-27 | 2022-05-23 | 高濃度抗c5抗体製剤 |
JP2023076675A JP2023090876A (ja) | 2017-07-27 | 2023-05-08 | 高濃度抗c5抗体製剤 |
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US201762537741P | 2017-07-27 | 2017-07-27 | |
US62/537,741 | 2017-07-27 | ||
PCT/US2018/044071 WO2019023564A1 (en) | 2017-07-27 | 2018-07-27 | ANTI-C5 ANTIBODY FORMULATIONS WITH HIGH CONCENTRATION |
Related Child Applications (1)
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JP2022083775A Division JP7277649B2 (ja) | 2017-07-27 | 2022-05-23 | 高濃度抗c5抗体製剤 |
Publications (4)
Publication Number | Publication Date |
---|---|
JP2020528894A JP2020528894A (ja) | 2020-10-01 |
JP2020528894A5 JP2020528894A5 (ja) | 2021-09-09 |
JPWO2019023564A5 true JPWO2019023564A5 (ja) | 2022-03-15 |
JP7079844B2 JP7079844B2 (ja) | 2022-06-02 |
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Family Applications (3)
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JP2020503739A Active JP7079844B2 (ja) | 2017-07-27 | 2018-07-27 | 高濃度抗c5抗体製剤 |
JP2022083775A Active JP7277649B2 (ja) | 2017-07-27 | 2022-05-23 | 高濃度抗c5抗体製剤 |
JP2023076675A Pending JP2023090876A (ja) | 2017-07-27 | 2023-05-08 | 高濃度抗c5抗体製剤 |
Family Applications After (2)
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JP2022083775A Active JP7277649B2 (ja) | 2017-07-27 | 2022-05-23 | 高濃度抗c5抗体製剤 |
JP2023076675A Pending JP2023090876A (ja) | 2017-07-27 | 2023-05-08 | 高濃度抗c5抗体製剤 |
Country Status (19)
Country | Link |
---|---|
US (3) | US11365241B2 (ja) |
EP (2) | EP4218813A3 (ja) |
JP (3) | JP7079844B2 (ja) |
KR (2) | KR20230066126A (ja) |
CN (2) | CN111315411B (ja) |
AU (2) | AU2018306612C1 (ja) |
BR (1) | BR112020001703B1 (ja) |
CA (1) | CA3069756A1 (ja) |
CO (1) | CO2020001960A2 (ja) |
DK (1) | DK3658184T3 (ja) |
ES (1) | ES2965486T3 (ja) |
FI (1) | FI3658184T3 (ja) |
HU (1) | HUE064436T2 (ja) |
LT (1) | LT3658184T (ja) |
MX (2) | MX2020001052A (ja) |
PL (1) | PL3658184T3 (ja) |
PT (1) | PT3658184T (ja) |
SI (1) | SI3658184T1 (ja) |
WO (1) | WO2019023564A1 (ja) |
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CA3118282A1 (en) * | 2018-10-30 | 2020-05-07 | Alexion Pharmaceuticals, Inc. | Subcutaneous dosage and administration of anti-c5 antibodies for treatment of paroxysmal nocturnal hemoglobinuria (pnh) |
JP2022520107A (ja) * | 2019-02-14 | 2022-03-28 | アレクシオン ファーマシューティカルズ, インコーポレイテッド | 全身型重症筋無力症を治療するための抗c5抗体の投与量及び投与 |
JP2022544589A (ja) * | 2019-08-16 | 2022-10-19 | リジェネロン・ファーマシューティカルズ・インコーポレイテッド | 高濃度抗c5製剤 |
WO2021067526A1 (en) * | 2019-10-02 | 2021-04-08 | Alexion Pharmaceuticals, Inc. | Complement inhibitors for treating drug-induced complement-mediated response |
US20230002482A1 (en) * | 2019-11-08 | 2023-01-05 | Alexion Pharmaceuticals, Inc. | High concentration anti-c5 antibody formulations |
EP4149421A1 (en) * | 2020-05-15 | 2023-03-22 | F. Hoffmann-La Roche AG | Prevention of visible particle formation in parenteral protein solutions |
MX2023003256A (es) * | 2020-09-21 | 2023-04-11 | Alexion Pharma Inc | Dosificacion y administracion de anticuerpos anti-c5 para tratar la glomerulonefritis (gn) mediada por c5, incluyendo la nefritis lupica (nl) y/o la nefropatia por iga (niga). |
KR20230134533A (ko) * | 2021-01-22 | 2023-09-21 | 알렉시온 파마슈티칼스, 인코포레이티드 | 항-c5 항체를 이용한 보체 매개 혈전성 미세혈관병증의치료 방법 |
TW202404632A (zh) * | 2022-04-04 | 2024-02-01 | 瑞士商赫孚孟拉羅股份公司 | 用於藉由使用抗c5抗體克羅伐單抗治療或預防格林-巴利症候群之劑量及投予方案 |
WO2024072798A1 (en) * | 2022-09-28 | 2024-04-04 | Alexion Pharmaceuticals, Inc. | Dosage and administration of anti-c5 antibodies for preventing or minimizing cardiac surgery associated acute kidney injury (csa-aki) and/or subsequent major adverse kidney events (make) in patients with chronic kidney disease |
CN116712390B (zh) * | 2023-08-04 | 2023-11-14 | 上海览屹医药科技有限公司 | 一种高浓度高稳定性的抗体制剂及其制备方法 |
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