RU2005110423A - Полипептиды, обработанные has, особенно эритропоэтин, обработанный has - Google Patents
Полипептиды, обработанные has, особенно эритропоэтин, обработанный has Download PDFInfo
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- C08B31/00—Preparation of derivatives of starch
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- C08B31/12—Ethers having alkyl or cycloalkyl radicals substituted by heteroatoms, e.g. hydroxyalkyl or carboxyalkyl starch
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- C08B31/08—Ethers
- C08B31/10—Alkyl or cycloalkyl ethers
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- 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
- A61K47/56—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 organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule
- A61K47/61—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 organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule the organic macromolecular compound being a polysaccharide or a derivative thereof
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- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
- A61K9/0021—Intradermal administration, e.g. through microneedle arrays, needleless injectors
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- A61P7/06—Antianaemics
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- 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
- C07K14/475—Growth factors; Growth regulators
- C07K14/505—Erythropoietin [EPO]
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- 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
- C07K14/52—Cytokines; Lymphokines; Interferons
- C07K14/53—Colony-stimulating factor [CSF]
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- 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
- C07K14/52—Cytokines; Lymphokines; Interferons
- C07K14/54—Interleukins [IL]
- C07K14/5412—IL-6
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- 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
- C07K14/52—Cytokines; Lymphokines; Interferons
- C07K14/54—Interleukins [IL]
- C07K14/55—IL-2
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- 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
- C07K14/52—Cytokines; Lymphokines; Interferons
- C07K14/555—Interferons [IFN]
- C07K14/56—IFN-alpha
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- 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
- C07K14/52—Cytokines; Lymphokines; Interferons
- C07K14/555—Interferons [IFN]
- C07K14/565—IFN-beta
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K17/00—Carrier-bound or immobilised peptides; Preparation thereof
- C07K17/02—Peptides being immobilised on, or in, an organic carrier
- C07K17/10—Peptides being immobilised on, or in, an organic carrier the carrier being a carbohydrate
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- C08B—POLYSACCHARIDES; DERIVATIVES THEREOF
- C08B31/00—Preparation of derivatives of starch
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- C—CHEMISTRY; METALLURGY
- C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
- C08B—POLYSACCHARIDES; DERIVATIVES THEREOF
- C08B31/00—Preparation of derivatives of starch
- C08B31/003—Crosslinking of starch
- C08B31/006—Crosslinking of derivatives of starch
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- C—CHEMISTRY; METALLURGY
- C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
- C08B—POLYSACCHARIDES; DERIVATIVES THEREOF
- C08B31/00—Preparation of derivatives of starch
- C08B31/08—Ethers
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- C—CHEMISTRY; METALLURGY
- C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
- C08B—POLYSACCHARIDES; DERIVATIVES THEREOF
- C08B31/00—Preparation of derivatives of starch
- C08B31/18—Oxidised starch
- C08B31/185—Derivatives of oxidised starch, e.g. crosslinked oxidised starch
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- C08H—DERIVATIVES OF NATURAL MACROMOLECULAR COMPOUNDS
- C08H1/00—Macromolecular products derived from proteins
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
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Claims (25)
1. Конъюгат гидроксиалкилкрахмала (HAS)-эритропоэтина (EPO) (HAS-EPO), содержащий одну или несколько молекул HAS, где каждый HAS конъюгирован с EPO через углеводный фрагмент.
2. HAS-EPO по п.1, отличающийся тем, что указанный EPO имеет аминокислотную последовательность человеческого EPO.
3. HAS-EPO по п.1, отличающийся тем, что указанный EPO содержит одну или несколько углеводных боковых цепей, присоединенных к EPO посредством N- и/или O-гликозилирования, где предпочтительно указанные углеводные боковые цепи присоединены к EPO в процессе продукции в клетках млекопитающего, особенно человека, насекомого или дрожжей.
4. HAS-EPO по любому из пп.1-3, отличающийся тем, что указанный HAS конъюгирован с EPO через линкерную молекулу.
5. HAS-EPO по любому из пп.1-3, отличающийся тем, что указанный HAS конъюгирован с EPO по его восстанавливающему концу, предпочтительно, исключительно по его восстанавливающему концу.
6. HAS-EPO по любому из пп.1-3, отличающийся тем, что указанный HAS конъюгирован с ЕРО через свободную гидразидную, гидроксиламиновую, тиольную или семикарбазидную функциональную группу, введенную в HAS до конъюгирования.
7. HAS-EPO по п.3, отличающийся тем, что указанный HAS конъюгирован с ЕРО через углеводный фрагмент, который является частью боковых углеводных цепей и который предпочтительно является окисленным.
8. HAS-EPO по п.7, отличающийся тем, что указанный HAS конъюгирован с остатком галактозы или сиаловой кислоты в боковых углеводных цепях.
9. HAS-EPO по любому из пп.1-3, содержащий 1-12, предпочтительно 1-6 или 1-3, наиболее предпочтительно 1-4 молекул HAS на молекулу EPO.
10. HAS-EPO по любому из пп.1-3, отличающийся тем, что указанный HAS выбирают из группы, состоящей из гидроксиэтилкрахмала, гидроксипропилкрахмала и гидроксибутилкрахмала, предпочтительно гидроксиэтилкрахмала (HES), и где указанный HES предпочтительно имеет молекулярную массу от 1 до 300 кДа, предпочтительно от 5 до 100 кДа, и где указанный HES предпочтительно проявляет степень молярного замещения от 0,1 до 0,8, а соотношение С2:С6-замещения в диапазоне 2-20 по гидроксиэтильным группам.
11. Способ получения конъюгата гидроксиалкилкрахмала (HAS)-эритропоэтина (EPO) (HAS-EPO), предусматривающий стадии:
a) получения EPO, способного к реакции с модифицированным HAS,
b) получения модифицированного HAS, способного к реакции с EPO со стадии а), и
c) проведения реакции EPO со стадии а) с HAS со стадии b), посредством чего получают HAS-EPO, содержащий одну или несколько молекул HAS, где каждый HAS конъюгирован с EPO через углеводный фрагмент.
12. Способ по п.11, отличающийся тем, что указанный EPO имеет аминокислотную последовательность человеческого EPO.
13. Способ по любому из п.11 или 12, отличающийся тем, что указанный EPO получают рекомбинантным способом.
14. Способ по любому из п.11 или 12, отличающийся тем, что указанный HAS конъюгирован с EPO по его восстанавливающему концу, предпочтительно, исключительно по его восстанавливающему концу.
15. Способ по любому из п.11 или 12, отличающийся тем, что указанный EPO содержит одну или несколько боковых углеводных цепей, присоединенных к EPO посредством N- и/или O-гликозилирования, где предпочтительно указанные углеводные боковые цепи присоединены к EPO в процессе продукции в клетках млекопитающего, особенно человека, насекомого или дрожжей.
16. Способ по п.15, отличающийся тем, что указанный HAS конъюгирован с EPO через углеводный фрагмент, который является частью боковых углеводных цепей.
17. Способ по п.16, отличающийся тем, что на стадии а) EPO модифицируют путем окисления по меньшей мере одного углеводного фрагмента, предпочтительно по меньшей мере одного концевого сахаридного звена, более предпочтительно галактозы в одной или нескольких боковых углеводных цепях EPO.
18. Способ по п.17, отличающийся тем, что концевое сахаридное звено окисляют после частичного или полного (ферментативного и/или химического) удаления концевой сиаловой кислоты.
19. Способ по п.18, отличающийся тем, что на стадии с) модифицированный HAS конъюгируют с окисленным концевым сахаридным звеном.
20. Способ по любому из п.18 или 19, отличающийся тем, что указанный HAS модифицируют таким образом, что он содержит свободную гидразидную, гидроксиламиновую, тиольную или семикарбазидную функциональную группу.
21. Способ по любому из п.11 или 12, отличающийся тем, что стадию с) проводят в реакционной среде, содержащей по меньшей мере 10 мас.% H2O.
22. Способ по любому из п.11 или 12, отличающийся тем, что указанный HAS конъюгирован с ЕРО через линкерную молекулу.
23. Способ по любому из п.11 или 12, отличающийся тем, что указанный HAS представляет собой гидроксиэтилкрахмал, гидроксипропилкрахмал и гидроксибутилкрахмал, предпочтительно гидроксиэтилкрахмал (HES), и и где указанный HES предпочтительно имеет молекулярную массу от 1 до 300 кДа, предпочтительно от 5 до 100 кДа, и где указанный HES предпочтительно проявляет степень молярного замещения от 0,1 до 0,8, а соотношение С2:С6-замещения в диапазоне 2-20 по гидроксиэтильным группам.
24. HAS-ЕРО, получаемый в соответствии со способом по п.18.
25. Фармацевтическая композиция, содержащая HAS-ЕРО по любому из п.1 или 24.
Applications Claiming Priority (4)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US40978102P | 2002-09-11 | 2002-09-11 | |
US60/409,781 | 2002-09-11 | ||
EP02020425.1 | 2002-09-11 | ||
EP02020425A EP1400533A1 (en) | 2002-09-11 | 2002-09-11 | HASylated polypeptides, especially HASylated erythropoietin |
Publications (2)
Publication Number | Publication Date |
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RU2005110423A true RU2005110423A (ru) | 2006-01-20 |
RU2328505C2 RU2328505C2 (ru) | 2008-07-10 |
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Family Applications (3)
Application Number | Title | Priority Date | Filing Date |
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RU2005110415/04A RU2329274C2 (ru) | 2002-09-11 | 2003-08-08 | Способ получения производных гидроксиалкилкрахмала |
RU2005110423/04A RU2328505C2 (ru) | 2002-09-11 | 2003-08-08 | Полипептиды, обработанные has, особенно эритропоэтин, обработанный has |
RU2005110412/04A RU2326891C2 (ru) | 2002-09-11 | 2003-08-08 | Производные гидроксиалкилкрахмала |
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RU2005110415/04A RU2329274C2 (ru) | 2002-09-11 | 2003-08-08 | Способ получения производных гидроксиалкилкрахмала |
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RU2005110412/04A RU2326891C2 (ru) | 2002-09-11 | 2003-08-08 | Производные гидроксиалкилкрахмала |
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US (5) | US7815893B2 (ru) |
EP (8) | EP1398322B1 (ru) |
JP (4) | JP2006516534A (ru) |
KR (3) | KR101174510B1 (ru) |
CN (2) | CN100348618C (ru) |
AR (3) | AR041097A1 (ru) |
AT (3) | ATE406387T1 (ru) |
AU (6) | AU2003255406B2 (ru) |
BR (3) | BR0314107A (ru) |
CA (2) | CA2496317C (ru) |
CY (1) | CY1109813T1 (ru) |
DE (7) | DE03020423T1 (ru) |
DK (3) | DK1398322T3 (ru) |
ES (4) | ES2213507T3 (ru) |
HK (4) | HK1136226A1 (ru) |
IL (5) | IL166506A0 (ru) |
MX (4) | MXPA05002591A (ru) |
NO (2) | NO20051419L (ru) |
PL (3) | PL375037A1 (ru) |
PT (3) | PT1398322E (ru) |
RU (3) | RU2329274C2 (ru) |
SI (2) | SI1398327T1 (ru) |
TW (1) | TW200418875A (ru) |
WO (3) | WO2004024776A1 (ru) |
ZA (1) | ZA200600651B (ru) |
Families Citing this family (157)
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DE10112825A1 (de) * | 2001-03-16 | 2002-10-02 | Fresenius Kabi De Gmbh | HESylierung von Wirkstoffen in wässriger Lösung |
DE10209822A1 (de) | 2002-03-06 | 2003-09-25 | Biotechnologie Ges Mittelhesse | Kopplung niedermolekularer Substanzen an ein modifiziertes Polysaccharid |
DE10209821A1 (de) | 2002-03-06 | 2003-09-25 | Biotechnologie Ges Mittelhesse | Kopplung von Proteinen an ein modifiziertes Polysaccharid |
DE10242076A1 (de) * | 2002-09-11 | 2004-03-25 | Fresenius Kabi Deutschland Gmbh | HAS-Allergen-Konjugate |
CA2496317C (en) | 2002-09-11 | 2014-02-18 | Fresenius Kabi Deutschland Gmbh | Method of producing hydroxyalkyl starch derivatives |
ES2214166T1 (es) * | 2002-09-11 | 2004-09-16 | Fresenius Kabi Deutschland Gmbh | Polipeptidos has-ilados, especialmente, eriptropoyetina has-ilada. |
AU2003273413A1 (en) | 2002-10-08 | 2004-05-04 | Fresenius Kabi Deutschland Gmbh | Pharmaceutically active oligosaccharide conjugates |
DE10256558A1 (de) * | 2002-12-04 | 2004-09-16 | Supramol Parenteral Colloids Gmbh | Ester von Polysaccharid Aldonsäuren, Verfahren zu ihrer Herstellung und Verwendung zur Kopplung an pharmazeutische Wirkstoffe |
US20080274948A1 (en) * | 2003-08-08 | 2008-11-06 | Fresenius Kabi Deutschland Gmbh | Conjugates of Hydroxyalkyl Starch and G-Csf |
WO2005014655A2 (en) * | 2003-08-08 | 2005-02-17 | Fresenius Kabi Deutschland Gmbh | Conjugates of hydroxyalkyl starch and a protein |
KR101154343B1 (ko) * | 2003-08-08 | 2012-07-05 | 프레제니우스 카비 도이치란트 게엠베하 | 히드록시알킬 스타치 및 g-csf의 컨쥬게이트 |
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