KR20200035496A - 치료학적 단백질 제형의 제조 방법 및 이러한 방법에 의해 생산된 항체 제형 - Google Patents

치료학적 단백질 제형의 제조 방법 및 이러한 방법에 의해 생산된 항체 제형 Download PDF

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KR20200035496A
KR20200035496A KR1020207008879A KR20207008879A KR20200035496A KR 20200035496 A KR20200035496 A KR 20200035496A KR 1020207008879 A KR1020207008879 A KR 1020207008879A KR 20207008879 A KR20207008879 A KR 20207008879A KR 20200035496 A KR20200035496 A KR 20200035496A
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South Korea
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concentration
excipient
protein
ser
gly
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KR1020207008879A
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English (en)
Korean (ko)
Inventor
쥬디 케이 글린
브라이언 신 첸
다니엘 패트릭 라카시
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화이자 인코포레이티드
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39591—Stabilisation, fragmentation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/08—Solutions
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K1/00—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
    • C07K1/14—Extraction; Separation; Purification
    • C07K1/34—Extraction; Separation; Purification by filtration, ultrafiltration or reverse osmosis
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2866—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against receptors for cytokines, lymphokines, interferons
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/68—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/90—Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/94—Stability, e.g. half-life, pH, temperature or enzyme-resistance

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Immunology (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Biochemistry (AREA)
  • Organic Chemistry (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Analytical Chemistry (AREA)
  • Water Supply & Treatment (AREA)
  • Hematology (AREA)
  • Biomedical Technology (AREA)
  • Urology & Nephrology (AREA)
  • Biotechnology (AREA)
  • Cell Biology (AREA)
  • Food Science & Technology (AREA)
  • Physics & Mathematics (AREA)
  • General Physics & Mathematics (AREA)
  • Pathology (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
KR1020207008879A 2015-09-22 2016-09-08 치료학적 단백질 제형의 제조 방법 및 이러한 방법에 의해 생산된 항체 제형 Ceased KR20200035496A (ko)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201562222067P 2015-09-22 2015-09-22
US62/222,067 2015-09-22
PCT/IB2016/055355 WO2017051273A1 (en) 2015-09-22 2016-09-08 Method of preparing a therapeutic protein formulation and antibody formulation produced by such a method

Related Parent Applications (1)

Application Number Title Priority Date Filing Date
KR1020187007855A Division KR20180037056A (ko) 2015-09-22 2016-09-08 치료학적 단백질 제형의 제조 방법 및 이러한 방법에 의해 생산된 항체 제형

Publications (1)

Publication Number Publication Date
KR20200035496A true KR20200035496A (ko) 2020-04-03

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KR1020207008879A Ceased KR20200035496A (ko) 2015-09-22 2016-09-08 치료학적 단백질 제형의 제조 방법 및 이러한 방법에 의해 생산된 항체 제형
KR1020187007855A Ceased KR20180037056A (ko) 2015-09-22 2016-09-08 치료학적 단백질 제형의 제조 방법 및 이러한 방법에 의해 생산된 항체 제형

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KR1020187007855A Ceased KR20180037056A (ko) 2015-09-22 2016-09-08 치료학적 단백질 제형의 제조 방법 및 이러한 방법에 의해 생산된 항체 제형

Country Status (11)

Country Link
US (1) US20230134160A1 (https=)
EP (1) EP3352790A1 (https=)
JP (1) JP6925111B2 (https=)
KR (2) KR20200035496A (https=)
CN (1) CN108025072A (https=)
AU (1) AU2016329034B2 (https=)
CA (1) CA2999118C (https=)
HK (1) HK1255006A1 (https=)
IL (1) IL258311B (https=)
MX (1) MX2018003298A (https=)
WO (1) WO2017051273A1 (https=)

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JP2019517473A (ja) 2016-05-27 2019-06-24 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Ａｌｅｘｉｏｎ Ｐｈａｒｍａｃｅｕｔｉｃａｌｓ， Ｉｎｃ． 難治性全身型重症筋無力症の処置のための方法
CA3080187A1 (en) 2017-10-26 2019-05-02 Alexion Pharmaceuticals, Inc. Dosage and administration of anti-c5 antibodies for treatment of paroxysmal nocturnal hemoglobinuria (pnh) and atypical hemolytic uremic syndrome (ahus)
MX420109B (es) 2018-03-26 2025-02-10 Boehringer Ingelheim Animal Health Usa Inc Metodo para producir una composicion inmunogenica
US11103552B2 (en) 2018-05-10 2021-08-31 Regeneron Pharmaceuticals, Inc. High concentration VEGF receptor fusion protein containing formulations
WO2020006266A1 (en) 2018-06-28 2020-01-02 Alexion Pharmaceuticals, Inc. Methods of producing anti-c5 antibodies
KR102893280B1 (ko) * 2018-08-14 2025-12-01 브리스톨-마이어스 스큅 컴퍼니 개선된 단백질 회수
CN111110841A (zh) * 2018-10-31 2020-05-08 上海君实生物医药科技股份有限公司 含有抗pcsk9抗体的稳定制剂
EP3858422B1 (en) 2019-01-24 2022-11-02 Magenta Medical Ltd. Ventricular assist device
TWI871300B (zh) * 2019-01-28 2025-02-01 美商安進公司 藉由將藥物物質和藥物產品過程整體化的生物製劑製造之連續製造過程
KR102735988B1 (ko) 2019-02-18 2024-12-03 일라이 릴리 앤드 캄파니 치료 항체 제제
WO2021171310A1 (en) * 2020-02-24 2021-09-02 Indian Institute Of Technology Delhi A system for real-time monitoring of protein and excipients
CN111944046B (zh) * 2020-08-28 2021-04-09 江苏荃信生物医药有限公司 高浓度、低粘度抗人il-23单克隆抗体溶液的制备方法
WO2022041390A1 (zh) * 2020-08-28 2022-03-03 江苏荃信生物医药股份有限公司 包含高浓度抗人白介素23单克隆抗体的低粘度液体制剂及其制备方法
JP2024505128A (ja) * 2020-12-30 2024-02-05 アイ－エムエービー バイオファーマ カンパニー リミテッド 抗ｃｄ７３抗体の製剤
CN114014929B (zh) * 2021-11-04 2022-07-19 江苏荃信生物医药股份有限公司 一种抗人白介素-33单克隆抗体浓缩溶液的制备方法
EP4467828A3 (en) 2022-09-14 2025-02-12 Magenta Medical Ltd. Coupling between shaft and drive cable
WO2024165043A1 (en) * 2023-02-08 2024-08-15 Beigene Switzerland Gmbh Preparation methods for a highly concentrated pd1 antibody solution by applying single-pass tangential flow filtration (sptff)

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Publication number Priority date Publication date Assignee Title
US9415102B2 (en) * 2002-09-06 2016-08-16 Alexion Pharmaceuticals, Inc. High concentration formulations of anti-C5 antibodies
US20060051347A1 (en) * 2004-09-09 2006-03-09 Winter Charles M Process for concentration of antibodies and therapeutic products thereof
EP1871806A2 (en) * 2005-03-08 2008-01-02 Pharmacia & Upjohn Company LLC ANTI-MAdCAM ANTIBODY COMPOSITIONS
JP2010512356A (ja) * 2006-12-11 2010-04-22 エフ．ホフマン−ラ ロシュ アーゲー 非経口ａベータ抗体製剤
US20090208492A1 (en) * 2007-06-14 2009-08-20 Elan Pharmaceuticals, Inc. Lyophilized Immunoglobulin Formulations and Methods of Preparation
WO2010042705A1 (en) * 2008-10-09 2010-04-15 Medimmune, Llc Antibody formulation
DK2538968T3 (en) * 2010-02-24 2017-12-11 Chiesi Farm Spa PROCEDURE FOR THE PREPARATION AND PURIFICATION OF RECOMBINANT LYSOSOMAL ALFA MANNOSIDASE
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WO2012168491A1 (en) * 2011-06-10 2012-12-13 Novartis Ag Pharmaceutical formulations of pcsk9 antagonists
EP2583980A1 (en) * 2011-10-19 2013-04-24 Effimune Antibodies directed against the alpha chain of IL7 receptor - their use for the preparation of drug candidates
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EP2727602A1 (en) * 2012-10-31 2014-05-07 Takeda GmbH Method for preparation of a high concentration liquid formulation of an antibody

Also Published As

Publication number Publication date
CA2999118C (en) 2022-06-14
CN108025072A (zh) 2018-05-11
IL258311A (en) 2018-05-31
JP2017095440A (ja) 2017-06-01
AU2016329034B2 (en) 2019-05-23
IL258311B (en) 2021-04-29
MX2018003298A (es) 2018-06-20
JP6925111B2 (ja) 2021-08-25
EP3352790A1 (en) 2018-08-01
RU2018110145A3 (https=) 2020-02-10
US20230134160A1 (en) 2023-05-04
AU2016329034A1 (en) 2018-03-15
KR20180037056A (ko) 2018-04-10
WO2017051273A1 (en) 2017-03-30
RU2018110145A (ru) 2019-10-23
CA2999118A1 (en) 2017-03-30
HK1255006A1 (zh) 2019-08-02

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