AU2016329034B2 - Method of preparing a therapeutic protein formulation and antibody formulation produced by such a method - Google Patents

Method of preparing a therapeutic protein formulation and antibody formulation produced by such a method Download PDF

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Publication number
AU2016329034B2
AU2016329034B2 AU2016329034A AU2016329034A AU2016329034B2 AU 2016329034 B2 AU2016329034 B2 AU 2016329034B2 AU 2016329034 A AU2016329034 A AU 2016329034A AU 2016329034 A AU2016329034 A AU 2016329034A AU 2016329034 B2 AU2016329034 B2 AU 2016329034B2
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AU
Australia
Prior art keywords
concentration
protein
excipient
final
solution
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
AU2016329034A
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English (en)
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AU2016329034A1 (en
Inventor
Brian Xin CHEN
Judy Kay GLYNN
Daniel Patrick Lacasse
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Pfizer Inc
Original Assignee
Pfizer Inc
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Publication date
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Publication of AU2016329034A1 publication Critical patent/AU2016329034A1/en
Application granted granted Critical
Publication of AU2016329034B2 publication Critical patent/AU2016329034B2/en
Ceased legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • 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
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/08—Solutions
    • 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
    • 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

Landscapes

  • 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)
AU2016329034A 2015-09-22 2016-09-08 Method of preparing a therapeutic protein formulation and antibody formulation produced by such a method Ceased AU2016329034B2 (en)

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

Publications (2)

Publication Number Publication Date
AU2016329034A1 AU2016329034A1 (en) 2018-03-15
AU2016329034B2 true AU2016329034B2 (en) 2019-05-23

Family

ID=57045234

Family Applications (1)

Application Number Title Priority Date Filing Date
AU2016329034A Ceased AU2016329034B2 (en) 2015-09-22 2016-09-08 Method of preparing a therapeutic protein formulation and antibody formulation produced by such a method

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)

Citations (4)

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Publication number Priority date Publication date Assignee Title
US20060051347A1 (en) * 2004-09-09 2006-03-09 Winter Charles M Process for concentration of antibodies and therapeutic products thereof
WO2008071394A1 (en) * 2006-12-11 2008-06-19 F. Hoffmann-La Roche Ag Abeta antibody parenteral formulation
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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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
EP1871806A2 (en) * 2005-03-08 2008-01-02 Pharmacia & Upjohn Company LLC ANTI-MAdCAM ANTIBODY COMPOSITIONS
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
AR080291A1 (es) * 2010-02-24 2012-03-28 Rinat Neuroscience Corp Anticuerpos antagonistas anti receptor de il-7 y procedimientos
CN104271600B (zh) * 2012-05-14 2018-09-14 诺和诺德股份有限公司 稳定化的蛋白溶液
US9592297B2 (en) * 2012-08-31 2017-03-14 Bayer Healthcare Llc Antibody and protein formulations
EP2727602A1 (en) * 2012-10-31 2014-05-07 Takeda GmbH Method for preparation of a high concentration liquid formulation of an antibody

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20060051347A1 (en) * 2004-09-09 2006-03-09 Winter Charles M Process for concentration of antibodies and therapeutic products thereof
WO2008071394A1 (en) * 2006-12-11 2008-06-19 F. Hoffmann-La Roche Ag Abeta antibody parenteral formulation
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

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
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
KR20200035496A (ko) 2020-04-03
CA2999118A1 (en) 2017-03-30
HK1255006A1 (zh) 2019-08-02

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FGA Letters patent sealed or granted (standard patent)
MK14 Patent ceased section 143(a) (annual fees not paid) or expired