HK1255006A1 - 制备治疗用蛋白质制剂的方法和由这种方法生产的抗体制剂 - Google Patents
制备治疗用蛋白质制剂的方法和由这种方法生产的抗体制剂 Download PDFInfo
- Publication number
- HK1255006A1 HK1255006A1 HK18114122.2A HK18114122A HK1255006A1 HK 1255006 A1 HK1255006 A1 HK 1255006A1 HK 18114122 A HK18114122 A HK 18114122A HK 1255006 A1 HK1255006 A1 HK 1255006A1
- Authority
- HK
- Hong Kong
- Prior art keywords
- excipient
- concentration
- protein
- ser
- additive solution
- 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
- A61K39/39591—Stabilisation, fragmentation
-
- 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
- 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
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)
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201562222067P | 2015-09-22 | 2015-09-22 | |
| US62/222067 | 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 (1)
| Publication Number | Publication Date |
|---|---|
| HK1255006A1 true HK1255006A1 (zh) | 2019-08-02 |
Family
ID=57045234
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HK18114122.2A HK1255006A1 (zh) | 2015-09-22 | 2016-09-08 | 制备治疗用蛋白质制剂的方法和由这种方法生产的抗体制剂 |
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=) |
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 |
| 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) |
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 |
| 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 |
| AR080291A1 (es) * | 2010-02-24 | 2012-03-28 | Rinat Neuroscience Corp | Anticuerpos antagonistas anti receptor de il-7 y procedimientos |
| 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 |
| 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 |
-
2016
- 2016-09-08 US US15/761,777 patent/US20230134160A1/en active Pending
- 2016-09-08 HK HK18114122.2A patent/HK1255006A1/zh unknown
- 2016-09-08 CN CN201680054397.XA patent/CN108025072A/zh active Pending
- 2016-09-08 MX MX2018003298A patent/MX2018003298A/es unknown
- 2016-09-08 KR KR1020207008879A patent/KR20200035496A/ko not_active Ceased
- 2016-09-08 CA CA2999118A patent/CA2999118C/en active Active
- 2016-09-08 AU AU2016329034A patent/AU2016329034B2/en not_active Ceased
- 2016-09-08 KR KR1020187007855A patent/KR20180037056A/ko not_active Ceased
- 2016-09-08 EP EP16774987.8A patent/EP3352790A1/en active Pending
- 2016-09-08 WO PCT/IB2016/055355 patent/WO2017051273A1/en 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 |
|---|---|
| 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 |
| KR20200035496A (ko) | 2020-04-03 |
| CA2999118A1 (en) | 2017-03-30 |
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