MX367817B - Procedimiento de preparación mejorado para producción de alto rendimiento de conjugado polipeptídico fisiológicamente activo. - Google Patents
Procedimiento de preparación mejorado para producción de alto rendimiento de conjugado polipeptídico fisiológicamente activo.Info
- Publication number
- MX367817B MX367817B MX2015011668A MX2015011668A MX367817B MX 367817 B MX367817 B MX 367817B MX 2015011668 A MX2015011668 A MX 2015011668A MX 2015011668 A MX2015011668 A MX 2015011668A MX 367817 B MX367817 B MX 367817B
- Authority
- MX
- Mexico
- Prior art keywords
- physiologically active
- active polypeptide
- conjugate
- polypeptide conjugate
- preparing
- Prior art date
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- A61K38/22—Hormones
- A61K38/28—Insulins
-
- 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
- A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
- A61K47/51—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
- A61K47/68—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
-
- 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
- A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
- A61K47/51—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
- A61K47/68—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
- A61K47/6801—Drug-antibody or immunoglobulin conjugates defined by the pharmacologically or therapeutically active agent
- A61K47/6803—Drugs conjugated to an antibody or immunoglobulin, e.g. cisplatin-antibody conjugates
- A61K47/6811—Drugs conjugated to an antibody or immunoglobulin, e.g. cisplatin-antibody conjugates the drug being a protein or peptide, e.g. transferrin or bleomycin
-
- 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
- C07K1/107—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length by chemical modification of precursor peptides
- C07K1/1072—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length by chemical modification of precursor peptides by covalent attachment of residues or functional groups
- C07K1/1077—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length by chemical modification of precursor peptides by covalent attachment of residues or functional groups by covalent attachment of residues other than amino acids or peptide residues, e.g. sugars, polyols, fatty acids
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- C07K14/575—Hormones
- C07K14/62—Insulins
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2319/00—Fusion polypeptide
- C07K2319/30—Non-immunoglobulin-derived peptide or protein having an immunoglobulin constant or Fc region, or a fragment thereof, attached thereto
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Organic Chemistry (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Immunology (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Animal Behavior & Ethology (AREA)
- Epidemiology (AREA)
- Pharmacology & Pharmacy (AREA)
- Molecular Biology (AREA)
- Zoology (AREA)
- Gastroenterology & Hepatology (AREA)
- Endocrinology (AREA)
- Diabetes (AREA)
- Biochemistry (AREA)
- Biophysics (AREA)
- Genetics & Genomics (AREA)
- Toxicology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Analytical Chemistry (AREA)
- Peptides Or Proteins (AREA)
- Medicinal Preparation (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Abstract
La presente invención se refiere a un procedimiento de preparación de un conjugado engarzando un polipéptido fisiológicamente activo, un engarce de polímero no peptidilo y una región constante de inmunoglobulina mediante un enlace covalente. Más particularmente, la presente invención se refiere a un procedimiento para preparar eficientemente el conjugado de polipéptido fisiológicamente activo, en el que se utiliza una sal en una reacción de acoplamiento para mejorar el problema de bajo rendimiento de la producción durante la preparación del conjugado de polipéptido fisiológicamente activo. Puede producirse el complejo de polipéptido fisiológicamente activo-polímero no peptidilo-región constante de inmunoglobulina con alta pureza y alto rendimiento mediante el procedimiento de preparación de la presente invención. Debido al procedimiento de preparación del conjugado de polipéptido fisiológicamente activo, pueden reducirse los costos de producción. Por lo tanto, puede utilizarse el procedimiento para desarrollar formulaciones de acción prolongada de polipéptidos fisiológicamente activos, que tienen aplicabilidad industrial mejorada y conformidad con las reglamentaciones sobre fármacos.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| KR20130023602 | 2013-03-05 | ||
| PCT/KR2014/001818 WO2014137161A1 (ko) | 2013-03-05 | 2014-03-05 | 생리활성 폴리펩타이드 결합체의 고수율 생산을 위한 개선된 제조 방법 |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| MX2015011668A MX2015011668A (es) | 2015-12-16 |
| MX367817B true MX367817B (es) | 2019-09-06 |
Family
ID=51491612
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| MX2015011668A MX367817B (es) | 2013-03-05 | 2014-03-05 | Procedimiento de preparación mejorado para producción de alto rendimiento de conjugado polipeptídico fisiológicamente activo. |
Country Status (23)
| Country | Link |
|---|---|
| US (1) | US10660940B2 (es) |
| EP (1) | EP2966083B1 (es) |
| JP (1) | JP6374412B2 (es) |
| KR (1) | KR102136336B1 (es) |
| CN (2) | CN110590903A (es) |
| AR (1) | AR094987A1 (es) |
| AU (1) | AU2014226741B2 (es) |
| BR (1) | BR112015021764B1 (es) |
| CA (1) | CA2903365C (es) |
| ES (1) | ES2743612T3 (es) |
| HK (1) | HK1217717A1 (es) |
| IL (1) | IL240869B (es) |
| MX (1) | MX367817B (es) |
| MY (1) | MY186423A (es) |
| NZ (1) | NZ712948A (es) |
| PH (1) | PH12015501952B1 (es) |
| PT (1) | PT2966083T (es) |
| RU (1) | RU2677796C9 (es) |
| SA (1) | SA515360980B1 (es) |
| SG (1) | SG11201506937RA (es) |
| TW (1) | TWI647240B (es) |
| WO (1) | WO2014137161A1 (es) |
| ZA (1) | ZA201507312B (es) |
Families Citing this family (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| AR081755A1 (es) * | 2010-04-02 | 2012-10-17 | Hanmi Holdings Co Ltd | Formulacion de accion prolongada de la hormona estimuladora de los foliculos donde se usa un fragmento de inmunoglobulina, metodo de preparacion y metodo para tratar a un sujeto que sufre un trastorno reproductivo |
| KR20130049671A (ko) | 2011-11-04 | 2013-05-14 | 한미사이언스 주식회사 | 생리활성 폴리펩타이드 결합체 제조 방법 |
| AR090281A1 (es) | 2012-03-08 | 2014-10-29 | Hanmi Science Co Ltd | Proceso mejorado para la preparacion de un complejo polipeptidico fisiologicamente activo |
| US20200283492A1 (en) * | 2017-09-29 | 2020-09-10 | Hanmi Pharm Co., Ltd. | Long acting protein complex having an enhanced efficiency |
| CN114945587A (zh) | 2019-07-18 | 2022-08-26 | 韩美药品株式会社 | 通过制备中间体而制备长效药物缀合物的新方法 |
Family Cites Families (14)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| GB8824591D0 (en) * | 1988-10-20 | 1988-11-23 | Royal Free Hosp School Med | Fractionation process |
| US6096871A (en) | 1995-04-14 | 2000-08-01 | Genentech, Inc. | Polypeptides altered to contain an epitope from the Fc region of an IgG molecule for increased half-life |
| WO1997034631A1 (en) | 1996-03-18 | 1997-09-25 | Board Of Regents, The University Of Texas System | Immunoglobin-like domains with increased half lives |
| CA2407956A1 (en) * | 2000-05-03 | 2001-11-08 | Amgen Inc. | Modified peptides as therapeutic agents |
| US20040062748A1 (en) * | 2002-09-30 | 2004-04-01 | Mountain View Pharmaceuticals, Inc. | Polymer conjugates with decreased antigenicity, methods of preparation and uses thereof |
| CN102139114A (zh) * | 2003-02-26 | 2011-08-03 | 尼克塔治疗公司 | 聚合物-因子viii部分缀合物 |
| KR101135244B1 (ko) * | 2007-11-29 | 2012-04-24 | 한미사이언스 주식회사 | 인슐린 분비 펩타이드 결합체를 포함하는 비만 관련질환 치료용 조성물 |
| AU2004282984B2 (en) | 2003-11-13 | 2011-07-14 | Hanmi Science Co., Ltd. | Protein complex using immunoglobulin fragment andmethod for the preparation thereof |
| CU23556A1 (es) * | 2005-11-30 | 2010-07-20 | Ct Ingenieria Genetica Biotech | Estructura polimérica semejante a dendrímero para la obtención de conjugados de interés farmacéutico |
| NZ601248A (en) | 2008-04-14 | 2014-06-27 | Halozyme Inc | Modified hyaluronidases and uses in treating hyaluronan-associated diseases and conditions |
| MY151184A (en) * | 2008-07-23 | 2014-04-30 | Hanmi Science Co Ltd | A polypeptide complex comprising non-peptidyl polymer having three functional ends |
| WO2010078376A2 (en) | 2008-12-30 | 2010-07-08 | Ventana Medical Systems, Inc. | Fc-specific polymer-conjugated antibodies and their diagnostic use |
| AR081066A1 (es) * | 2010-04-02 | 2012-06-06 | Hanmi Holdings Co Ltd | Conjugado de insulina donde se usa un fragmento de inmunoglobulina |
| KR101330868B1 (ko) | 2010-06-08 | 2013-11-18 | 한미사이언스 주식회사 | 면역글로불린 단편을 이용한 인슐린 유도체 약물 결합체 |
-
2014
- 2014-03-05 KR KR1020140026256A patent/KR102136336B1/ko active IP Right Grant
- 2014-03-05 CN CN201910874160.1A patent/CN110590903A/zh active Pending
- 2014-03-05 BR BR112015021764-8A patent/BR112015021764B1/pt active IP Right Grant
- 2014-03-05 CA CA2903365A patent/CA2903365C/en active Active
- 2014-03-05 NZ NZ712948A patent/NZ712948A/en unknown
- 2014-03-05 US US14/772,493 patent/US10660940B2/en active Active
- 2014-03-05 SG SG11201506937RA patent/SG11201506937RA/en unknown
- 2014-03-05 TW TW103107577A patent/TWI647240B/zh not_active IP Right Cessation
- 2014-03-05 ES ES14760968T patent/ES2743612T3/es active Active
- 2014-03-05 AR ARP140100703A patent/AR094987A1/es active IP Right Grant
- 2014-03-05 AU AU2014226741A patent/AU2014226741B2/en active Active
- 2014-03-05 RU RU2015139510A patent/RU2677796C9/ru active
- 2014-03-05 WO PCT/KR2014/001818 patent/WO2014137161A1/ko active Application Filing
- 2014-03-05 JP JP2015561270A patent/JP6374412B2/ja active Active
- 2014-03-05 MY MYPI2015002182A patent/MY186423A/en unknown
- 2014-03-05 PT PT14760968T patent/PT2966083T/pt unknown
- 2014-03-05 CN CN201480011914.6A patent/CN105143255B/zh active Active
- 2014-03-05 EP EP14760968.9A patent/EP2966083B1/en active Active
- 2014-03-05 MX MX2015011668A patent/MX367817B/es active IP Right Grant
-
2015
- 2015-08-27 IL IL240869A patent/IL240869B/en active IP Right Grant
- 2015-09-03 SA SA515360980A patent/SA515360980B1/ar unknown
- 2015-09-03 PH PH12015501952A patent/PH12015501952B1/en unknown
- 2015-10-02 ZA ZA2015/07312A patent/ZA201507312B/en unknown
-
2016
- 2016-05-18 HK HK16105703.9A patent/HK1217717A1/zh unknown
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| FG | Grant or registration |