IL258311B - A method for preparing a therapeutic protein formulation and an antibody formulation produced by the method - Google Patents
A method for preparing a therapeutic protein formulation and an antibody formulation produced by the methodInfo
- Publication number
- IL258311B IL258311B IL258311A IL25831118A IL258311B IL 258311 B IL258311 B IL 258311B IL 258311 A IL258311 A IL 258311A IL 25831118 A IL25831118 A IL 25831118A IL 258311 B IL258311 B IL 258311B
- Authority
- IL
- Israel
- Prior art keywords
- formulation
- preparing
- therapeutic protein
- produced
- antibody
- Prior art date
Links
- 238000009472 formulation Methods 0.000 title 2
- 238000000034 method Methods 0.000 title 2
- 239000000203 mixture Substances 0.000 title 2
- 102000004169 proteins and genes Human genes 0.000 title 1
- 108090000623 proteins and genes Proteins 0.000 title 1
- 230000001225 therapeutic effect Effects 0.000 title 1
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 [IGs], e.g. monoclonal or polyclonal antibodies
- C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
- C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
- C07K16/2866—Immunoglobulins [IGs], 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)
- Mycology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Biophysics (AREA)
- Genetics & Genomics (AREA)
- Analytical Chemistry (AREA)
- Water Supply & Treatment (AREA)
- Biomedical Technology (AREA)
- Hematology (AREA)
- Urology & Nephrology (AREA)
- Cell Biology (AREA)
- Physics & Mathematics (AREA)
- General Physics & Mathematics (AREA)
- Pathology (AREA)
- Food Science & Technology (AREA)
- Biotechnology (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)
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201562222067P | 2015-09-22 | 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 |
|---|---|
| IL258311A IL258311A (en) | 2018-05-31 |
| IL258311B true IL258311B (en) | 2021-04-29 |
Family
ID=57045234
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| IL258311A IL258311B (en) | 2015-09-22 | 2018-03-22 | A method for preparing a therapeutic protein formulation and an antibody formulation produced by the method |
Country Status (11)
| Country | Link |
|---|---|
| US (1) | US20230134160A1 (enExample) |
| EP (1) | EP3352790A1 (enExample) |
| JP (1) | JP6925111B2 (enExample) |
| KR (2) | KR20200035496A (enExample) |
| CN (1) | CN108025072A (enExample) |
| AU (1) | AU2016329034B2 (enExample) |
| CA (1) | CA2999118C (enExample) |
| HK (1) | HK1255006A1 (enExample) |
| IL (1) | IL258311B (enExample) |
| MX (1) | MX2018003298A (enExample) |
| WO (1) | WO2017051273A1 (enExample) |
Families Citing this family (17)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| 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 |
| KR20200070355A (ko) | 2017-10-26 | 2020-06-17 | 알렉시온 파마슈티칼스, 인코포레이티드 | 발작성 야간 혈색소뇨 (pnh) 및 비정형 용혈성 요독 증후군 (ahus)의 치료를 위한 항-c5 항체의 투여량 및 투여 |
| CN112088013B (zh) * | 2018-03-26 | 2024-12-06 | 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 |
| NZ770284A (en) | 2018-05-10 | 2025-11-28 | Regeneron Pharma | 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 |
| EP3837273B1 (en) * | 2018-08-14 | 2025-09-24 | Bristol-Myers Squibb Company | Improved 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 |
| EP3782666B1 (en) | 2019-01-24 | 2021-08-11 | Magenta Medical Ltd. | Manufacturing an impeller |
| 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 |
| MX2021009851A (es) | 2019-02-18 | 2021-09-10 | Lilly Co Eli | Formulacion de anticuerpos terapeuticos. |
| 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 |
| KR20230127292A (ko) * | 2020-12-30 | 2023-08-31 | 아이-맵 바이오파마 컴파니 리미티드 | 항-cd73 항체의 제제 |
| 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 |
| JP2025530825A (ja) | 2022-09-14 | 2025-09-17 | マジェンタ・メディカル・リミテッド | 心室補助デバイスの湾曲 |
| 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) |
Family Cites Families (13)
| 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 |
| DK1865986T3 (en) * | 2005-03-08 | 2016-04-11 | Pfizer Prod Inc | The anti-CTLA-4 antibody compositions |
| CN101553504A (zh) * | 2006-12-11 | 2009-10-07 | 豪夫迈·罗氏有限公司 | Aβ抗体胃肠外制剂 |
| 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 |
| US8298535B2 (en) * | 2010-02-24 | 2012-10-30 | Rinat Neuroscience Corp. | Anti-IL-7 receptor antibodies |
| EA022220B1 (ru) * | 2010-02-24 | 2015-11-30 | Сюменекс А/С | Способ получения и очистки рекомбинантной лизосомальной альфа-маннозидазы |
| 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 |
| 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 |
-
2016
- 2016-09-08 AU AU2016329034A patent/AU2016329034B2/en active Active
- 2016-09-08 EP EP16774987.8A patent/EP3352790A1/en active Pending
- 2016-09-08 CA CA2999118A patent/CA2999118C/en active Active
- 2016-09-08 WO PCT/IB2016/055355 patent/WO2017051273A1/en not_active Ceased
- 2016-09-08 HK HK18114122.2A patent/HK1255006A1/zh unknown
- 2016-09-08 KR KR1020207008879A patent/KR20200035496A/ko not_active Ceased
- 2016-09-08 MX MX2018003298A patent/MX2018003298A/es unknown
- 2016-09-08 US US15/761,777 patent/US20230134160A1/en active Pending
- 2016-09-08 KR KR1020187007855A patent/KR20180037056A/ko not_active Ceased
- 2016-09-08 CN CN201680054397.XA patent/CN108025072A/zh active Pending
- 2016-09-16 JP JP2016181594A patent/JP6925111B2/ja active Active
-
2018
- 2018-03-22 IL IL258311A patent/IL258311B/en active IP Right Grant
Also Published As
| Publication number | Publication date |
|---|---|
| WO2017051273A1 (en) | 2017-03-30 |
| EP3352790A1 (en) | 2018-08-01 |
| US20230134160A1 (en) | 2023-05-04 |
| KR20200035496A (ko) | 2020-04-03 |
| IL258311A (en) | 2018-05-31 |
| JP2017095440A (ja) | 2017-06-01 |
| AU2016329034B2 (en) | 2019-05-23 |
| CA2999118A1 (en) | 2017-03-30 |
| JP6925111B2 (ja) | 2021-08-25 |
| KR20180037056A (ko) | 2018-04-10 |
| HK1255006A1 (zh) | 2019-08-02 |
| RU2018110145A3 (enExample) | 2020-02-10 |
| CN108025072A (zh) | 2018-05-11 |
| AU2016329034A1 (en) | 2018-03-15 |
| MX2018003298A (es) | 2018-06-20 |
| RU2018110145A (ru) | 2019-10-23 |
| CA2999118C (en) | 2022-06-14 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| FF | Patent granted | ||
| KB | Patent renewed |