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
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Pfizer Inc
Original Assignee
Pfizer Inc
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Publication date
Application filed by Pfizer Inc filed Critical Pfizer Inc
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)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Immunology (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Biochemistry (AREA)
  • Organic Chemistry (AREA)
  • Microbiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Mycology (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Analytical Chemistry (AREA)
  • Water Supply & Treatment (AREA)
  • Urology & Nephrology (AREA)
  • Hematology (AREA)
  • Biomedical Technology (AREA)
  • Biotechnology (AREA)
  • Food Science & Technology (AREA)
  • Physics & Mathematics (AREA)
  • General Physics & Mathematics (AREA)
  • Pathology (AREA)
  • Cell Biology (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) KR20180037056A (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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CA3024618A1 (en) 2016-05-27 2017-11-30 Alexion Pharmaceuticals, Inc. Methods for treatment of refractory generalized myasthenia gravis
CN118512588A (zh) 2017-10-26 2024-08-20 亚力兄制药公司 用于治疗阵发性夜间性血红蛋白尿(pnh)和非典型溶血性尿毒症综合征(ahus)的抗c5抗体的剂量和施用
CN119488586A (zh) * 2018-03-26 2025-02-21 勃林格殷格翰动物保健美国有限公司 制备免疫原性组合物的方法
DK4364724T3 (da) 2018-05-10 2025-12-22 Regeneron Pharma Formuleringer med høj koncentration af VEGF-receptorfusionsprotein
US12312394B2 (en) 2018-06-28 2025-05-27 Alexion Pharmaceuticals, Inc. Methods of producing anti-C5 antibodies
US12103949B2 (en) * 2018-08-14 2024-10-01 Bristol-Myers Squibb Company Protein recovery
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
EP4653041A3 (en) 2019-01-24 2026-03-04 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
CN120241997A (zh) 2019-02-18 2025-07-04 伊莱利利公司 治疗性抗体制剂
EP4111208A4 (en) * 2020-02-24 2024-04-10 Indian Institute of Technology, Delhi REAL-TIME MONITORING SYSTEM OF PROTEIN AND EXCELLENT SUBSTANCES
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
WO2022142053A1 (en) * 2020-12-30 2022-07-07 I-Mab Biopharma Co., Ltd Formulations of anti-cd73 antibodies
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
EP4429754B1 (en) 2022-09-14 2025-02-12 Magenta Medical Ltd. Pump-head portion of ventricular assist device
TW202432179A (zh) * 2023-02-08 2024-08-16 瑞士商百濟神州瑞士有限責任公司 用於高度濃縮的ｐｄ１抗體溶液的超濾／滲濾方法

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

Family Cites Families (9)

* Cited by examiner, † Cited by third party
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US9415102B2 (en) * 2002-09-06 2016-08-16 Alexion Pharmaceuticals, Inc. High concentration formulations of anti-C5 antibodies
ES2569409T3 (es) * 2005-03-08 2016-05-10 Pfizer Products Inc. Composiciones de anticuerpo anti-CTLA-4
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
AR080291A1 (es) * 2010-02-24 2012-03-28 Rinat Neuroscience Corp Anticuerpos antagonistas anti receptor de il-7 y procedimientos
CA2790786C (en) * 2010-02-24 2019-09-24 Zymenex A/S Process for production and purification of recombinant lysosomal alpha-mannosidase
BR112014028129A2 (pt) * 2012-05-14 2017-06-27 Novo Nordisk As soluções de proteína estabilizadas
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)

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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

Also Published As

Publication number Publication date
MX2018003298A (es) 2018-06-20
US20230134160A1 (en) 2023-05-04
IL258311B (en) 2021-04-29
EP3352790A1 (en) 2018-08-01
HK1255006A1 (zh) 2019-08-02
IL258311A (en) 2018-05-31
RU2018110145A3 (https=) 2020-02-10
JP2017095440A (ja) 2017-06-01
CN108025072A (zh) 2018-05-11
WO2017051273A1 (en) 2017-03-30
AU2016329034A1 (en) 2018-03-15
JP6925111B2 (ja) 2021-08-25
CA2999118C (en) 2022-06-14
RU2018110145A (ru) 2019-10-23
CA2999118A1 (en) 2017-03-30
KR20200035496A (ko) 2020-04-03
KR20180037056A (ko) 2018-04-10

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MK14 Patent ceased section 143(a) (annual fees not paid) or expired