BR112022005410A2 - Métodos e composições compreendendo um anticorpo monoclonal anti-ctla4 com proteínas de célula hospedeira reduzidas e estabilidade de polissorbato 80 aumentada - Google Patents
Métodos e composições compreendendo um anticorpo monoclonal anti-ctla4 com proteínas de célula hospedeira reduzidas e estabilidade de polissorbato 80 aumentadaInfo
- Publication number
- BR112022005410A2 BR112022005410A2 BR112022005410A BR112022005410A BR112022005410A2 BR 112022005410 A2 BR112022005410 A2 BR 112022005410A2 BR 112022005410 A BR112022005410 A BR 112022005410A BR 112022005410 A BR112022005410 A BR 112022005410A BR 112022005410 A2 BR112022005410 A2 BR 112022005410A2
- Authority
- BR
- Brazil
- Prior art keywords
- host cell
- polysorbate
- methods
- compositions
- cell proteins
- Prior art date
Links
- 238000000034 method Methods 0.000 title abstract 6
- 102000004169 proteins and genes Human genes 0.000 title abstract 6
- 108090000623 proteins and genes Proteins 0.000 title abstract 6
- 239000000203 mixture Substances 0.000 title abstract 5
- 235000010482 polyoxyethylene sorbitan monooleate Nutrition 0.000 title abstract 4
- 239000000244 polyoxyethylene sorbitan monooleate Substances 0.000 title abstract 4
- 229920000053 polysorbate 80 Polymers 0.000 title abstract 4
- 229940068968 polysorbate 80 Drugs 0.000 title abstract 4
- 210000004027 cell Anatomy 0.000 abstract 4
- 238000004519 manufacturing process Methods 0.000 abstract 3
- 102000004882 Lipase Human genes 0.000 abstract 2
- 108090001060 Lipase Proteins 0.000 abstract 2
- 239000004367 Lipase Substances 0.000 abstract 2
- 235000019421 lipase Nutrition 0.000 abstract 2
- 102000008203 CTLA-4 Antigen Human genes 0.000 abstract 1
- 108010021064 CTLA-4 Antigen Proteins 0.000 abstract 1
- 239000000427 antigen Substances 0.000 abstract 1
- 102000036639 antigens Human genes 0.000 abstract 1
- 108091007433 antigens Proteins 0.000 abstract 1
- 238000009472 formulation Methods 0.000 abstract 1
- 239000012634 fragment 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
- A61K39/39591—Stabilisation, fragmentation
-
- 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
- C07K16/2803—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily
- C07K16/2818—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily against CD28 or CD152
-
- 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
- A61K47/20—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic 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
- A61K47/26—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
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
- C07K16/06—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies from serum
- C07K16/065—Purification, fragmentation
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
- C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
-
- 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)
- Immunology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Organic Chemistry (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Biochemistry (AREA)
- Molecular Biology (AREA)
- Genetics & Genomics (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Biophysics (AREA)
- Engineering & Computer Science (AREA)
- Animal Behavior & Ethology (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Mycology (AREA)
- Microbiology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Peptides Or Proteins (AREA)
- Enzymes And Modification Thereof (AREA)
- Medicinal Preparation (AREA)
Abstract
métodos e composições compreendendo um anticorpo monoclonal anti-ctla4 com proteínas de célula hospedeira reduzidas e estabilidade de polissorbato 80 aumentada. são fornecidos na presente invenção métodos para separar lipases de célula hospedeira de uma proteína de produção em processos cromatográficos e métodos de aprimoramento de estabilidade de polissorbato 80 em uma formulação de proteína de produção ao separar lipases de célula hospedeira da proteína de produção usando processos cromatográficos. também são fornecidas na presente invenção composições compreendendo anticorpos ou fragmentos de ligação ao antígeno dos mesmos que se ligam ao antígeno 4 associado ao linfócito t citotóxico (ctla4). em outro aspecto, tais composições compreendem adicionalmente um nível reduzido de proteínas de célula hospedeira e/ou nível aumentado de estabilidade de polissorbato 80 (ps-80).
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201962904331P | 2019-09-23 | 2019-09-23 | |
| PCT/US2020/051355 WO2021061504A1 (en) | 2019-09-23 | 2020-09-18 | Methods and compositions comprising an anti-ctla4 monoclonal antibody with reduced host cell proteins and increased polysorbate-80 stability |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| BR112022005410A2 true BR112022005410A2 (pt) | 2022-06-21 |
Family
ID=75166366
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| BR112022005410A BR112022005410A2 (pt) | 2019-09-23 | 2020-09-18 | Métodos e composições compreendendo um anticorpo monoclonal anti-ctla4 com proteínas de célula hospedeira reduzidas e estabilidade de polissorbato 80 aumentada |
Country Status (10)
| Country | Link |
|---|---|
| US (1) | US20240115701A1 (pt) |
| EP (1) | EP4034546A4 (pt) |
| JP (1) | JP2023500775A (pt) |
| KR (1) | KR20220069043A (pt) |
| CN (1) | CN114650999A (pt) |
| AU (1) | AU2020356303A1 (pt) |
| BR (1) | BR112022005410A2 (pt) |
| CA (1) | CA3154726A1 (pt) |
| MX (1) | MX2022003432A (pt) |
| WO (1) | WO2021061504A1 (pt) |
Families Citing this family (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2023163968A1 (en) * | 2022-02-24 | 2023-08-31 | Merck Sharp & Dohme Llc | Stable formulations of a multivalent vhh based cytotoxic t lymphocyte associated antigen 4 (ctla4) binder binding to human ctla4 and methods of use thereof |
| WO2024083074A1 (en) * | 2022-10-17 | 2024-04-25 | Beigene, Ltd. | Formulations containing anti-tigit antibody and methods of use thereof |
Family Cites Families (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2015095568A1 (en) * | 2013-12-18 | 2015-06-25 | Kelvin Lee | Reduction of lipase activity in product formulations |
| ES2877532T3 (es) * | 2015-08-21 | 2021-11-17 | Hoffmann La Roche | Procedimiento para la reducción de proteínas de célula huésped en cromatografía de afinidad |
| CA3060695A1 (en) * | 2017-05-02 | 2018-11-08 | Merck Sharp & Dohme Corp. | Stable formulations of anti-ctla4 antibodies alone and in combination with programmed death receptor 1 (pd-1) antibodies and methods of use thereof |
| EP3826743A4 (en) * | 2018-07-25 | 2022-09-14 | Merck Sharp & Dohme Corp. | METHODS FOR SEPARATION OF HOST CELL LIPASES FROM A PRODUCTION PROTEIN IN CHROMATOGRAPHIC METHODS |
-
2020
- 2020-09-18 AU AU2020356303A patent/AU2020356303A1/en active Pending
- 2020-09-18 KR KR1020227013167A patent/KR20220069043A/ko unknown
- 2020-09-18 JP JP2022518012A patent/JP2023500775A/ja active Pending
- 2020-09-18 BR BR112022005410A patent/BR112022005410A2/pt unknown
- 2020-09-18 WO PCT/US2020/051355 patent/WO2021061504A1/en unknown
- 2020-09-18 EP EP20868322.7A patent/EP4034546A4/en active Pending
- 2020-09-18 CA CA3154726A patent/CA3154726A1/en active Pending
- 2020-09-18 CN CN202080077572.3A patent/CN114650999A/zh active Pending
- 2020-09-18 MX MX2022003432A patent/MX2022003432A/es unknown
- 2020-09-18 US US17/642,870 patent/US20240115701A1/en active Pending
Also Published As
| Publication number | Publication date |
|---|---|
| CA3154726A1 (en) | 2021-04-01 |
| KR20220069043A (ko) | 2022-05-26 |
| US20240115701A1 (en) | 2024-04-11 |
| EP4034546A1 (en) | 2022-08-03 |
| WO2021061504A1 (en) | 2021-04-01 |
| EP4034546A4 (en) | 2024-01-31 |
| MX2022003432A (es) | 2022-04-19 |
| AU2020356303A1 (en) | 2022-04-14 |
| JP2023500775A (ja) | 2023-01-11 |
| CN114650999A (zh) | 2022-06-21 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| B25A | Requested transfer of rights approved |
Owner name: MERCK SHARP AND DOHME LLC (US) |