MX2018003298A - Metodo para preparar una formulacion de proteinas terapeuticas y formulacion de anticuerpos producida por tal metodo. - Google Patents
Metodo para preparar una formulacion de proteinas terapeuticas y formulacion de anticuerpos producida por tal metodo.Info
- Publication number
- MX2018003298A MX2018003298A MX2018003298A MX2018003298A MX2018003298A MX 2018003298 A MX2018003298 A MX 2018003298A MX 2018003298 A MX2018003298 A MX 2018003298A MX 2018003298 A MX2018003298 A MX 2018003298A MX 2018003298 A MX2018003298 A MX 2018003298A
- Authority
- MX
- Mexico
- Prior art keywords
- protein
- formulation
- preparing
- excipient
- therapeutic protein
- 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
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- 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
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- 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)
Abstract
La invención se refiere a un método para preparar una formulación de proteínas que incluye una proteína terapéutica, el método comprende las etapas de: proporcionar una solución que comprende dicha proteína; concentrar la proteína en la solución mediante una primera etapa de ultrafiltración; diafiltrar la solución con un tampón de diafiltración que incluye al menos un primer excipiente, con lo que se obtiene un retenido que comprende la proteína y el primer excipiente; concentrar adicionalmente la proteína en el retenido mediante una segunda etapa de ultrafiltración; y añadir al menos un excipiente final, con lo que se obtiene la formulación de proteínas con una concentración deseada de proteínas. De acuerdo con la invención, el método además comprende, antes de la segunda etapa de ultrafiltración, añadir un segundo excipiente al retenido obtenido a partir de la etapa de diafiltración. La invención también se dirige a formulaciones de anticuerpos producidas por el método anterior.
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 (1)
| Publication Number | Publication Date |
|---|---|
| MX2018003298A true MX2018003298A (es) | 2018-06-20 |
Family
ID=57045234
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| MX2018003298A MX2018003298A (es) | 2015-09-22 | 2016-09-08 | Metodo para preparar una formulacion de proteinas terapeuticas y formulacion de anticuerpos producida por tal metodo. |
Country Status (11)
| Country | Link |
|---|---|
| US (1) | US20230134160A1 (es) |
| EP (1) | EP3352790A1 (es) |
| JP (1) | JP6925111B2 (es) |
| KR (2) | KR20200035496A (es) |
| CN (1) | CN108025072A (es) |
| AU (1) | AU2016329034B2 (es) |
| CA (1) | CA2999118C (es) |
| HK (1) | HK1255006A1 (es) |
| IL (1) | IL258311B (es) |
| MX (1) | MX2018003298A (es) |
| WO (1) | WO2017051273A1 (es) |
Families Citing this family (14)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP3700928A1 (en) | 2017-10-26 | 2020-09-02 | Alexion Pharmaceuticals, Inc. | Dosage and administration of anti-c5 antibodies for treatment of paroxysmal nocturnal hemoglobinuria (pnh) and atypical hemolytic uremic syndrome (ahus) |
| EP3672629A1 (en) * | 2018-03-26 | 2020-07-01 | Boehringer Ingelheim Animal Health USA Inc. | Method of producing an immunogenic composition |
| JOP20200275A1 (ar) | 2018-05-10 | 2020-11-02 | Regeneron Pharma | صيغ تحتوي على بروتين اندماج لمستقبلvegf مرتفعة التركيز |
| JP7538723B2 (ja) * | 2018-06-28 | 2024-08-22 | 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 | 抗ｃ５抗体の産生方法 |
| WO2020036903A1 (en) * | 2018-08-14 | 2020-02-20 | 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 |
| TW202043253A (zh) * | 2019-01-28 | 2020-12-01 | 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 |
| JP7266108B2 (ja) | 2019-02-18 | 2023-04-27 | イーライ リリー アンド カンパニー | 治療用抗体製剤 |
| WO2021171310A1 (en) * | 2020-02-24 | 2021-09-02 | Indian Institute Of Technology Delhi | A system for real-time monitoring of protein and excipients |
| 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 |
| 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 |
| 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 |
| 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 |
| KR100989280B1 (ko) * | 2005-03-08 | 2010-10-20 | 파마시아 앤드 업존 캄파니 엘엘씨 | 항-ｃｔｌａ-4 항체 조성물 |
| EP2094729A1 (en) * | 2006-12-11 | 2009-09-02 | F.Hoffmann-La Roche Ag | Abeta antibody parenteral formulation |
| 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 |
| ES2652330T3 (es) * | 2010-02-24 | 2018-02-01 | Chiesi Farmaceutici S.P.A. | Proceso para la producción y purificación de alfa-manosidasa lisosómica recombinante |
| SA114360064B1 (ar) * | 2010-02-24 | 2016-01-05 | رينات نيوروساينس كوربوريشن | طرق وأجسام مضادة معارضة ضد مستقبل il-7 |
| 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 CN CN201680054397.XA patent/CN108025072A/zh active Pending
- 2016-09-08 KR KR1020207008879A patent/KR20200035496A/ko not_active IP Right Cessation
- 2016-09-08 WO PCT/IB2016/055355 patent/WO2017051273A1/en active Application Filing
- 2016-09-08 US US15/761,777 patent/US20230134160A1/en active Pending
- 2016-09-08 CA CA2999118A patent/CA2999118C/en active Active
- 2016-09-08 EP EP16774987.8A patent/EP3352790A1/en active Pending
- 2016-09-08 KR KR1020187007855A patent/KR20180037056A/ko active Search and Examination
- 2016-09-08 MX MX2018003298A patent/MX2018003298A/es unknown
- 2016-09-08 AU AU2016329034A patent/AU2016329034B2/en active Active
- 2016-09-16 JP JP2016181594A patent/JP6925111B2/ja active Active
-
2018
- 2018-03-22 IL IL258311A patent/IL258311B/en active IP Right Grant
- 2018-11-06 HK HK18114122.2A patent/HK1255006A1/zh unknown
Also Published As
| Publication number | Publication date |
|---|---|
| CA2999118C (en) | 2022-06-14 |
| KR20180037056A (ko) | 2018-04-10 |
| JP2017095440A (ja) | 2017-06-01 |
| CA2999118A1 (en) | 2017-03-30 |
| JP6925111B2 (ja) | 2021-08-25 |
| AU2016329034B2 (en) | 2019-05-23 |
| IL258311B (en) | 2021-04-29 |
| US20230134160A1 (en) | 2023-05-04 |
| IL258311A (en) | 2018-05-31 |
| RU2018110145A (ru) | 2019-10-23 |
| CN108025072A (zh) | 2018-05-11 |
| AU2016329034A1 (en) | 2018-03-15 |
| EP3352790A1 (en) | 2018-08-01 |
| HK1255006A1 (zh) | 2019-08-02 |
| RU2018110145A3 (es) | 2020-02-10 |
| KR20200035496A (ko) | 2020-04-03 |
| WO2017051273A1 (en) | 2017-03-30 |
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