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
- 102000004169 proteins and genes Human genes 0.000 title abstract 9
- 108090000623 proteins and genes Proteins 0.000 title abstract 9
- 238000000034 method Methods 0.000 title abstract 6
- 238000009472 formulation Methods 0.000 title abstract 5
- 239000000203 mixture Substances 0.000 title abstract 5
- 230000001225 therapeutic effect Effects 0.000 title abstract 2
- 239000000546 pharmaceutical excipient Substances 0.000 abstract 4
- 239000012465 retentate Substances 0.000 abstract 3
- 238000000108 ultra-filtration Methods 0.000 abstract 3
- 238000011026 diafiltration Methods 0.000 abstract 2
- 239000012538 diafiltration buffer Substances 0.000 abstract 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)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Immunology (AREA)
- Molecular Biology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (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)
- 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 (15)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| MX2020004284A (es) | 2017-10-26 | 2020-10-28 | Alexion Pharma Inc | Dosis y administracion de anticuerpos anti-c5 para el tratamiento de la hemoglobinuria paroxistica nocturna (hpn) y el sindrome hemolitico uremico atipico (shua). |
| JP7162072B2 (ja) | 2018-03-26 | 2022-10-27 | ベーリンガー インゲルハイム アニマル ヘルス ユーエスエイ インコーポレイテッド | 免疫原性組成物を製造する方法 |
| BR112020022610A2 (pt) | 2018-05-10 | 2021-02-09 | Regeneron Pharmaceuticals, Inc. | proteína de fusão de receptor de vegf de alta concentração que contém formulações |
| WO2020006266A1 (en) * | 2018-06-28 | 2020-01-02 | Alexion Pharmaceuticals, Inc. | Methods of producing anti-c5 antibodies |
| EP3837273A1 (en) * | 2018-08-14 | 2021-06-23 | 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 |
| EP3917494A1 (en) * | 2019-01-28 | 2021-12-08 | Amgen Inc. | A continuous manufacturing process for biologics manufacturing by integration of drug substance and drug product processes |
| SG11202108627SA (en) | 2019-02-18 | 2021-09-29 | Lilly Co Eli | Therapeutic antibody formulation |
| EP4111208A4 (en) * | 2020-02-24 | 2024-04-10 | Indian Institute of Technology, Delhi | REAL-TIME MONITORING SYSTEM OF PROTEIN AND EXCELLENT SUBSTANCES |
| 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 |
| 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 |
| WO2024057256A2 (en) | 2022-09-14 | 2024-03-21 | Magenta Medical Ltd | Curvature of ventricular assist device |
| 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 |
| US20090238820A1 (en) * | 2005-03-08 | 2009-09-24 | Allan Corey M | ANTI-MAdCAM ANTIBODY COMPOSITIONS |
| RU2009126420A (ru) * | 2006-12-11 | 2011-01-20 | Ф.Хоффманн-Ля Рош Аг (Ch) | Парентеральная лекарственная форма антитела к абета |
| US20090208492A1 (en) * | 2007-06-14 | 2009-08-20 | Elan Pharmaceuticals, Inc. | Lyophilized Immunoglobulin Formulations and Methods of Preparation |
| US20110256149A1 (en) * | 2008-10-09 | 2011-10-20 | Medimmune, Llc | Antibody formulation |
| AR080291A1 (es) * | 2010-02-24 | 2012-03-28 | Rinat Neuroscience Corp | Anticuerpos antagonistas anti receptor de il-7 y procedimientos |
| DK2538968T3 (en) * | 2010-02-24 | 2017-12-11 | Chiesi Farm Spa | PROCEDURE FOR THE PREPARATION AND PURIFICATION OF RECOMBINANT LYSOSOMAL ALFA 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 |
| CA2873647A1 (en) * | 2012-05-14 | 2013-11-21 | Ole Elvang Jensen | Stabilised protein solutions |
| 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 CA CA2999118A patent/CA2999118C/en active Active
- 2016-09-08 KR KR1020207008879A patent/KR20200035496A/ko not_active Ceased
- 2016-09-08 US US15/761,777 patent/US20230134160A1/en active Pending
- 2016-09-08 WO PCT/IB2016/055355 patent/WO2017051273A1/en active Application Filing
- 2016-09-08 AU AU2016329034A patent/AU2016329034B2/en active Active
- 2016-09-08 EP EP16774987.8A patent/EP3352790A1/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
- 2018-11-06 HK HK18114122.2A patent/HK1255006A1/zh unknown
Also Published As
| Publication number | Publication date |
|---|---|
| CA2999118A1 (en) | 2017-03-30 |
| IL258311B (en) | 2021-04-29 |
| AU2016329034B2 (en) | 2019-05-23 |
| HK1255006A1 (zh) | 2019-08-02 |
| KR20180037056A (ko) | 2018-04-10 |
| RU2018110145A (ru) | 2019-10-23 |
| KR20200035496A (ko) | 2020-04-03 |
| JP6925111B2 (ja) | 2021-08-25 |
| CN108025072A (zh) | 2018-05-11 |
| CA2999118C (en) | 2022-06-14 |
| AU2016329034A1 (en) | 2018-03-15 |
| US20230134160A1 (en) | 2023-05-04 |
| RU2018110145A3 (es) | 2020-02-10 |
| JP2017095440A (ja) | 2017-06-01 |
| IL258311A (en) | 2018-05-31 |
| WO2017051273A1 (en) | 2017-03-30 |
| EP3352790A1 (en) | 2018-08-01 |
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