ES2564281T3 - Formulación de anticuerpos Abeta - Google Patents
Formulación de anticuerpos Abeta Download PDFInfo
- Publication number
- ES2564281T3 ES2564281T3 ES13707176.7T ES13707176T ES2564281T3 ES 2564281 T3 ES2564281 T3 ES 2564281T3 ES 13707176 T ES13707176 T ES 13707176T ES 2564281 T3 ES2564281 T3 ES 2564281T3
- Authority
- ES
- Spain
- Prior art keywords
- seq
- amino acid
- acid sequence
- abeta antibody
- sequence
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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Classifications
-
- 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
- A61K39/39533—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
- A61K39/3955—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
-
- 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
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
-
- 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
- A61K47/26—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
- 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
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/34—Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
-
- 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
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/28—Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
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- 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
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/40—Immunoglobulins specific features characterized by post-translational modification
- C07K2317/41—Glycosylation, sialylation, or fucosylation
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
- C07K2317/51—Complete heavy chain or Fd fragment, i.e. VH + CH1
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
- C07K2317/515—Complete light chain, i.e. VL + CL
-
- 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
- C07K2317/565—Complementarity determining region [CDR]
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Immunology (AREA)
- Organic Chemistry (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Molecular Biology (AREA)
- Biochemistry (AREA)
- Mycology (AREA)
- Microbiology (AREA)
- Biophysics (AREA)
- Genetics & Genomics (AREA)
- Dermatology (AREA)
- Endocrinology (AREA)
- Inorganic Chemistry (AREA)
- Neurology (AREA)
- Neurosurgery (AREA)
- Biomedical Technology (AREA)
- Psychiatry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Hospice & Palliative Care (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Peptides Or Proteins (AREA)
- Medicinal Preparation (AREA)
Abstract
Una formulación farmacéutica líquida estable de anticuerpo que contiene: - de 50 mg/ml a 200 mg/ml de un anticuerpo Abeta, - del 0,01 % al 0,1% de un poloxámero, con preferencia del poloxámero 188, - de 5 mM a 50 mM de un tampón, - de 100 mM a 300 mM de un estabilizante, de un pH comprendido aprox. entre 4,5 y 7,0, en la que el anticuerpo Abeta es un anticuerpo monoclonal que contiene una cadena larga y una cadena corta, dicha cadena larga del anticuerpo Abeta contiene un dominio VH que contiene: - una CDR1 que contiene la secuencia de aminoácidos de la Seq. Id. No. 4, - una CDR2 que contiene la secuencia de aminoácidos de la Seq. Id. No. 5, - una secuencia CDR3 que contiene la secuencia de aminoácidos de la Seq. Id. No. 6. y dicha cadena corta del anticuerpo Abeta contiene un dominio VL que contiene: - una CDR1 que contiene la secuencia de aminoácidos de la Seq. Id. No. 7, - una CDR2 que contiene la secuencia de aminoácidos de la Seq. Id. No. 8, - una secuencia CDR3 que contiene la secuencia de aminoácidos de la Seq. Id. No. 9.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP12158602 | 2012-03-08 | ||
| EP12158602 | 2012-03-08 | ||
| PCT/EP2013/054313 WO2013131866A1 (en) | 2012-03-08 | 2013-03-05 | Abeta antibody formulation |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| ES2564281T3 true ES2564281T3 (es) | 2016-03-21 |
Family
ID=47780075
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| ES13707176.7T Active ES2564281T3 (es) | 2012-03-08 | 2013-03-05 | Formulación de anticuerpos Abeta |
Country Status (25)
| Country | Link |
|---|---|
| US (1) | US20150030589A1 (es) |
| EP (1) | EP2822587B1 (es) |
| JP (1) | JP5859148B2 (es) |
| KR (1) | KR101666289B1 (es) |
| CN (1) | CN104159613B (es) |
| AR (2) | AR090272A1 (es) |
| AU (1) | AU2013229613B2 (es) |
| BR (1) | BR112014019667B1 (es) |
| CA (1) | CA2860543C (es) |
| CY (1) | CY1117363T1 (es) |
| DK (1) | DK2822587T3 (es) |
| ES (1) | ES2564281T3 (es) |
| HR (1) | HRP20160434T1 (es) |
| HU (1) | HUE028440T2 (es) |
| IL (1) | IL234120B (es) |
| MX (1) | MX351148B (es) |
| MY (1) | MY166045A (es) |
| NZ (1) | NZ626955A (es) |
| PL (1) | PL2822587T3 (es) |
| RS (1) | RS54644B1 (es) |
| RU (1) | RU2014140137A (es) |
| SG (1) | SG11201404481RA (es) |
| SI (1) | SI2822587T1 (es) |
| WO (1) | WO2013131866A1 (es) |
| ZA (1) | ZA201405103B (es) |
Families Citing this family (35)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| KR101374454B1 (ko) | 2005-03-31 | 2014-03-17 | 추가이 세이야쿠 가부시키가이샤 | 회합제어에 의한 폴리펩티드 제조방법 |
| EP4793360A2 (en) | 2006-03-31 | 2026-08-19 | Chugai Seiyaku Kabushiki Kaisha | Methods for controlling blood pharmacokinetics of antibodies |
| JP5144499B2 (ja) | 2006-03-31 | 2013-02-13 | 中外製薬株式会社 | 二重特異性抗体を精製するための抗体改変方法 |
| EP3127921A1 (en) | 2007-09-26 | 2017-02-08 | Chugai Seiyaku Kabushiki Kaisha | Method of modifying isoelectric point of antibody via amino acid substition in cdr |
| JO3672B1 (ar) | 2008-12-15 | 2020-08-27 | Regeneron Pharma | أجسام مضادة بشرية عالية التفاعل الكيماوي بالنسبة لإنزيم سبتيليسين كنفرتيز بروبروتين / كيكسين نوع 9 (pcsk9). |
| MX366337B (es) * | 2010-10-06 | 2019-07-05 | Regeneron Pharma | Formulaciones estabilizadas que contienen anticuerpos anti-receptor de interleucina-4 (il-4r). |
| CN105859889B (zh) | 2010-11-17 | 2020-01-07 | 中外制药株式会社 | 具有代替凝血因子viii的功能的功能的多特异性抗原结合分子 |
| CA2825778A1 (en) | 2011-01-28 | 2012-08-02 | Sanofi | Pharmaceutical compositions comprising human antibodies to pcsk9 |
| AR087305A1 (es) | 2011-07-28 | 2014-03-12 | Regeneron Pharma | Formulaciones estabilizadas que contienen anticuerpos anti-pcsk9, metodo de preparacion y kit |
| CA2925256C (en) | 2013-09-27 | 2023-08-15 | Chugai Seiyaku Kabushiki Kaisha | Method for producing polypeptide heteromultimer |
| US10428157B2 (en) | 2013-11-12 | 2019-10-01 | Sanofi Biotechnology | Dosing regimens for use with PCSK9 inhibitors |
| TWI701435B (zh) | 2014-09-26 | 2020-08-11 | 日商中外製藥股份有限公司 | 測定ｆｖｉｉｉ的反應性之方法 |
| TWI700300B (zh) | 2014-09-26 | 2020-08-01 | 日商中外製藥股份有限公司 | 中和具有第ｖｉｉｉ凝血因子（ｆｖｉｉｉ）機能替代活性的物質之抗體 |
| JP7082484B2 (ja) | 2015-04-01 | 2022-06-08 | 中外製薬株式会社 | ポリペプチド異種多量体の製造方法 |
| AU2016282334B2 (en) | 2015-06-24 | 2022-07-21 | F. Hoffmann-La Roche Ag | Anti-transferrin receptor antibodies with tailored affinity |
| EA201890519A1 (ru) | 2015-08-18 | 2018-07-31 | Ридженерон Фармасьютикалз, Инк. | Ингибирующие антитела против pcsk9 для лечения пациентов с гиперлипидемией, подвергающихся аферезу липопротеинов |
| MX2018003822A (es) | 2015-10-02 | 2018-06-22 | Hoffmann La Roche | Anticuerpos biespecificos contra el cd20 humano y el receptor de transferrina humano y metodos de uso. |
| AR106189A1 (es) | 2015-10-02 | 2017-12-20 | Hoffmann La Roche | ANTICUERPOS BIESPECÍFICOS CONTRA EL A-b HUMANO Y EL RECEPTOR DE TRANSFERRINA HUMANO Y MÉTODOS DE USO |
| US20200270363A1 (en) | 2015-12-25 | 2020-08-27 | Chugai Seiyaku Kabushiki Kaisha | Antibody having enhanced activity, and method for modifying same |
| SG11201803989WA (en) | 2015-12-28 | 2018-06-28 | Chugai Pharmaceutical Co Ltd | Method for promoting efficiency of purification of fc region-containing polypeptide |
| AU2017255077B2 (en) | 2016-04-28 | 2024-05-16 | Chugai Seiyaku Kabushiki Kaisha | Antibody-containing preparation |
| CA3027018A1 (en) | 2016-07-29 | 2018-02-01 | Chugai Seiyaku Kabushiki Kaisha | Bispecific antibody exhibiting increased alternative fviii-cofactor-function activity |
| US11352438B2 (en) | 2016-09-06 | 2022-06-07 | Chugai Seiyaku Kabushiki Kaisha | Methods of using a bispecific antibody that recognizes coagulation factor IX and/or activated coagulation factor IX and coagulation factor X and/or activated coagulation factor X |
| JP7209298B2 (ja) | 2017-03-31 | 2023-01-20 | 公立大学法人奈良県立医科大学 | 血液凝固第ｖｉｉｉ因子の機能を代替する多重特異性抗原結合分子を含有する、血液凝固第ｉｘ因子異常症の予防および／または治療に用いられる医薬組成物 |
| EP3632421B1 (en) * | 2017-05-30 | 2025-08-13 | Morinaga Milk Industry Co., Ltd. | Acetic acid and/or an acetic acid salt for use in the treatment of alzheimer-type dementia |
| MD3672631T3 (ro) * | 2017-08-22 | 2023-09-30 | Biogen Ma Inc | Compoziții farmaceutice conținând anticorpi anti-beta amiloidici |
| CA3071236A1 (en) | 2017-09-29 | 2019-04-04 | Chugai Seiyaku Kabushiki Kaisha | Multispecific antigen-binding molecule having blood coagulation factor viii (fviii) cofactor function-substituting activity, and pharmaceutical formulation containing said moleculeas active ingredient |
| KR20260090008A (ko) | 2017-11-01 | 2026-06-16 | 추가이 세이야쿠 가부시키가이샤 | 생물 활성이 저하된 항체 배리언트 및 아이소폼 |
| IL298989A (en) * | 2020-07-03 | 2023-02-01 | CSL Innovation Pty Ltd | High concentration promotion of factor XII antigen binding proteins |
| US20250042984A1 (en) * | 2021-12-20 | 2025-02-06 | CSL Innovation Pty Ltd | Protein formulations and uses thereof |
| EP4518837A1 (en) * | 2022-05-02 | 2025-03-12 | Regeneron Pharmaceuticals, Inc. | Anti-interleukin-4 receptor (il-4r) antibody formulations |
| WO2024246085A1 (en) | 2023-05-31 | 2024-12-05 | F. Hoffmann-La Roche Ag | Therapeutic use of bispecific anti-abeta/tfr antibodies |
| WO2026119372A1 (en) | 2024-12-02 | 2026-06-11 | F. Hoffmann-La Roche Ag | Therapeutic use of bispecific anti-abeta/tfr antibodies |
| JP2026096188A (ja) | 2024-12-02 | 2026-06-12 | エフ． ホフマン－ラ ロシュ アーゲー | 二重特異性抗Ａベータ／ＴｆＲ抗体の治療的使用 |
| WO2026119384A1 (en) | 2024-12-04 | 2026-06-11 | F. Hoffmann-La Roche Ag | Therapeutic use of bispecific anti-abeta/tfr antibodies |
Family Cites Families (12)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4816567A (en) | 1983-04-08 | 1989-03-28 | Genentech, Inc. | Recombinant immunoglobin preparations |
| US5204244A (en) | 1987-10-27 | 1993-04-20 | Oncogen | Production of chimeric antibodies by homologous recombination |
| US5202238A (en) | 1987-10-27 | 1993-04-13 | Oncogen | Production of chimeric antibodies by homologous recombination |
| US5959177A (en) | 1989-10-27 | 1999-09-28 | The Scripps Research Institute | Transgenic plants expressing assembled secretory antibodies |
| EP0604580A1 (en) | 1991-09-19 | 1994-07-06 | Genentech, Inc. | EXPRESSION IN E. COLI OF ANTIBODY FRAGMENTS HAVING AT LEAST A CYSTEINE PRESENT AS A FREE THIOL, USE FOR THE PRODUCTION OF BIFUNCTIONAL F(ab') 2? ANTIBODIES |
| US5789199A (en) | 1994-11-03 | 1998-08-04 | Genentech, Inc. | Process for bacterial production of polypeptides |
| US5840523A (en) | 1995-03-01 | 1998-11-24 | Genetech, Inc. | Methods and compositions for secretion of heterologous polypeptides |
| US6040498A (en) | 1998-08-11 | 2000-03-21 | North Caroline State University | Genetically engineered duckweed |
| US7125978B1 (en) | 1999-10-04 | 2006-10-24 | Medicago Inc. | Promoter for regulating expression of foreign genes |
| KR100797667B1 (ko) | 1999-10-04 | 2008-01-23 | 메디카고 인코포레이티드 | 외래 유전자의 전사를 조절하는 방법 |
| CA2632828C (en) * | 2005-12-12 | 2012-07-10 | F. Hoffmann-La Roche Ag | Antibodies against amyloid beta with glycosylation in the variable region |
| CN101553504A (zh) * | 2006-12-11 | 2009-10-07 | 豪夫迈·罗氏有限公司 | Aβ抗体胃肠外制剂 |
-
2013
- 2013-03-05 JP JP2014560323A patent/JP5859148B2/ja active Active
- 2013-03-05 MX MX2014009662A patent/MX351148B/es active IP Right Grant
- 2013-03-05 EP EP13707176.7A patent/EP2822587B1/en active Active
- 2013-03-05 RS RS20160187A patent/RS54644B1/sr unknown
- 2013-03-05 HR HRP20160434TT patent/HRP20160434T1/hr unknown
- 2013-03-05 CN CN201380012493.4A patent/CN104159613B/zh active Active
- 2013-03-05 SI SI201330150T patent/SI2822587T1/sl unknown
- 2013-03-05 ES ES13707176.7T patent/ES2564281T3/es active Active
- 2013-03-05 RU RU2014140137A patent/RU2014140137A/ru not_active Application Discontinuation
- 2013-03-05 NZ NZ626955A patent/NZ626955A/en unknown
- 2013-03-05 US US14/381,849 patent/US20150030589A1/en not_active Abandoned
- 2013-03-05 SG SG11201404481RA patent/SG11201404481RA/en unknown
- 2013-03-05 KR KR1020147025086A patent/KR101666289B1/ko active Active
- 2013-03-05 DK DK13707176.7T patent/DK2822587T3/en active
- 2013-03-05 PL PL13707176T patent/PL2822587T3/pl unknown
- 2013-03-05 CA CA2860543A patent/CA2860543C/en active Active
- 2013-03-05 WO PCT/EP2013/054313 patent/WO2013131866A1/en not_active Ceased
- 2013-03-05 MY MYPI2014002221A patent/MY166045A/en unknown
- 2013-03-05 BR BR112014019667-2A patent/BR112014019667B1/pt active IP Right Grant
- 2013-03-05 HU HUE13707176A patent/HUE028440T2/en unknown
- 2013-03-05 AU AU2013229613A patent/AU2013229613B2/en active Active
- 2013-03-07 AR ARP130100743A patent/AR090272A1/es not_active Application Discontinuation
-
2014
- 2014-07-11 ZA ZA2014/05103A patent/ZA201405103B/en unknown
- 2014-08-14 IL IL234120A patent/IL234120B/en active IP Right Grant
-
2016
- 2016-04-12 CY CY20161100295T patent/CY1117363T1/el unknown
-
2021
- 2021-06-25 AR ARP210101758A patent/AR122746A2/es unknown
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