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
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)
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 (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=) |
Families Citing this family (17)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| 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 |
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 |
| ES2569409T3 (es) * | 2005-03-08 | 2016-05-10 | Pfizer Products Inc. | Composiciones de anticuerpo anti-CTLA-4 |
| CL2007003583A1 (es) * | 2006-12-11 | 2008-07-18 | Hoffmann La Roche | Formulacion farmaceutica estable, parenteral, del anticuerpo contra el peptido beta amiloide (abeta); y uso de la formulacion para el tratamiento de la enfermedad de alzheimer. |
| 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 |
| 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 MX MX2018003298A patent/MX2018003298A/es unknown
- 2016-09-08 US US15/761,777 patent/US20230134160A1/en active Pending
- 2016-09-08 EP EP16774987.8A patent/EP3352790A1/en active Pending
- 2016-09-08 CN CN201680054397.XA patent/CN108025072A/zh active Pending
- 2016-09-08 WO PCT/IB2016/055355 patent/WO2017051273A1/en not_active Ceased
- 2016-09-08 CA CA2999118A patent/CA2999118C/en active Active
- 2016-09-08 KR KR1020187007855A patent/KR20180037056A/ko not_active Ceased
- 2016-09-08 HK HK18114122.2A patent/HK1255006A1/zh unknown
- 2016-09-08 AU AU2016329034A patent/AU2016329034B2/en not_active Ceased
- 2016-09-08 KR KR1020207008879A patent/KR20200035496A/ko not_active Ceased
- 2016-09-16 JP JP2016181594A patent/JP6925111B2/ja not_active Expired - Fee Related
-
2018
- 2018-03-22 IL IL258311A patent/IL258311B/en active IP Right Grant
Also Published As
| Publication number | Publication date |
|---|---|
| MX2018003298A (es) | 2018-06-20 |
| US20230134160A1 (en) | 2023-05-04 |
| AU2016329034B2 (en) | 2019-05-23 |
| 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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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| FF | Patent granted | ||
| KB | Patent renewed |