HRP20150372T1 - Dugotrajna pohrana neglikoziliranog rekombinantnog ljudskog g-csf - Google Patents
Dugotrajna pohrana neglikoziliranog rekombinantnog ljudskog g-csf Download PDFInfo
- Publication number
- HRP20150372T1 HRP20150372T1 HRP20150372TT HRP20150372T HRP20150372T1 HR P20150372 T1 HRP20150372 T1 HR P20150372T1 HR P20150372T T HRP20150372T T HR P20150372TT HR P20150372 T HRP20150372 T HR P20150372T HR P20150372 T1 HRP20150372 T1 HR P20150372T1
- Authority
- HR
- Croatia
- Prior art keywords
- csf
- composition
- temperature
- frozen
- range
- Prior art date
Links
- 230000007774 longterm Effects 0.000 title claims 2
- 239000000203 mixture Substances 0.000 claims 32
- 108010017080 Granulocyte Colony-Stimulating Factor Proteins 0.000 claims 24
- 102000004269 Granulocyte Colony-Stimulating Factor Human genes 0.000 claims 24
- 238000000034 method Methods 0.000 claims 15
- QTBSBXVTEAMEQO-UHFFFAOYSA-M Acetate Chemical compound CC([O-])=O QTBSBXVTEAMEQO-UHFFFAOYSA-M 0.000 claims 4
- 101000746367 Homo sapiens Granulocyte colony-stimulating factor Proteins 0.000 claims 4
- WHUUTDBJXJRKMK-VKHMYHEASA-N L-glutamic acid Chemical compound OC(=O)[C@@H](N)CCC(O)=O WHUUTDBJXJRKMK-VKHMYHEASA-N 0.000 claims 4
- 229930195712 glutamate Natural products 0.000 claims 4
- FBPFZTCFMRRESA-FSIIMWSLSA-N D-Glucitol Natural products OC[C@H](O)[C@H](O)[C@@H](O)[C@H](O)CO FBPFZTCFMRRESA-FSIIMWSLSA-N 0.000 claims 3
- 239000007788 liquid Substances 0.000 claims 3
- 239000000600 sorbitol Substances 0.000 claims 3
- 238000001816 cooling Methods 0.000 claims 2
- 238000009472 formulation Methods 0.000 claims 1
- 239000008194 pharmaceutical composition Substances 0.000 claims 1
- 239000004094 surface-active agent Substances 0.000 claims 1
Classifications
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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
- 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
- A61K38/19—Cytokines; Lymphokines; Interferons
- A61K38/193—Colony stimulating factors [CSF]
-
- 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
- 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
- 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
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P7/00—Drugs for disorders of the blood or the extracellular fluid
-
- 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
- C07K14/53—Colony-stimulating factor [CSF]
- C07K14/535—Granulocyte CSF; Granulocyte-macrophage CSF
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
- Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
- Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
- Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
Claims (13)
1. Postupak za stabilnu dugotrajnu pohranu neglikoziliranog rekombinantnog ljudskog G-CSF, naznačen time, da taj postupak obuhvaća sljedeće korake:
(a) pribavljanje vodenog acetata ili glutamata puferiranog G-CSF-sastava koji sadrži neglikozilirani rekombinantni ljudski G-CSF i sorbitol, pri čemu količina tog G-CSF je u rasponu od 0,1 mg/ml do 8,0 mg/ml i pri čemu spomenuti sastav ima volumen od 100 ml do 8 l;
(b) hlađenje G-CSF-sastava pribavljenog u koraku (a) do temperature od -15°C ili ispod toga za dobivanje zamrznute G-CSF-formulacije;
(c) pohranjivanje G-CSF-sastava dobivenog u koraku (b) u zamrznutom stanju na vremenski period od najmanje mjesec dana; i
(d) povećanje temperature zamrznutog G-CSF-sastava iz koraka (c) na temperaturu u rasponu od 2°C do 8°C u vremenskom periodu namještenom tako da dopusti sastavu odmrzavanje te za dobivanje tekućeg sastava koji ima sadržaj G-CSF od najmanje 95% sadržaja sastava pribavljenog u koraku (a).
2. Postupak prema zahtjevu 1, naznačen time, da je količina od G-CSF u puferiranom G-CSF-sastavu iz koraka (a) u rasponu od 0,25 mg/ml do 6,5 mg/ml.
3. Postupak prema zahtjevu 1 ili zahtjevu 2, naznačen time, da je pH-vrijednost puferiranog G-CSF-sastava od 3,5 do 5,0, poželjno od 3,7 do 4,8.
4. Postupak prema bilo kojem zahtjevu od 1 do 3, naznačen time, da je koncentracija acetata ili glutamata u puferiranom G-CSF-sastavu u rasponu od 0,5 mM do 100 mM, poželjno od 2 mM do 80 mM.
5. Postupak prema bilo kojem zahtjevu od 1 do 4, naznačen time, da je količina sorbitola u G-CSF-sastavu, u rasponu od 10 do 100 mg/ml, poželjno od 25 do 75 mg/ml.
6. Postupak prema bilo kojem zahtjevu od 1 do 5, naznačen time, da vodeni acetat ili glutamat puferiranog G-CSF-sastava, koji je pribavljen u koraku (a), ima volumen od 100 ml do 4 l, i još bolje od 100 ml do 1,5 l.
7. Postupak prema bilo kojem zahtjevu od 1 do 6, naznačen time, da se G-CSF-sastav u koraku (b) hladi do temperature od -15°C do -25°C ili do temperature od -60°C do -80°C.
8. Postupak prema bilo kojem zahtjevu od 1 do 7, naznačen time, da se zamrznuti G-CSF-sastav u koraku (c) pohranjuje u vremenskom periodu od najmanje tri mjeseca.
9. Postupak prema bilo kojem zahtjevu od 1 do 8, naznačen time, da se povećanje temperature zamrznutog G-CSF-sastava, na temperaturu u rasponu od 2°C do 8°C u koraku (d), ostvaruje pomoću postepenog ili linearnog povećavanja temperature u vremenskom periodu od najmanje 6 sati.
10. Postupak prema bilo kojem zahtjevu od 1 do 8, naznačen time, da se povećanje temperature zamrznutog G-CSF-sastava, na temperaturu u koraku (d), ostvaruje pomoću prebacivanja zamrznutog sastava na temperaturu u rasponu od 2°C do 8°C te pomoću održavanja sastava na spomenutoj temperaturi u vremenskom periodu od najmanje 12 sati, poželjno od najmanje 24 sata, i najbolje od najmanje 36 sati.
11. Postupak prema bilo kojem zahtjevu od 1 do 10, naznačen time, da je G-CSF-sastav oslobođen od tenzida.
12. Postupak prema bilo kojem zahtjevu od 1 do 10, naznačen time, da G-CSF-sastav sadrži tenzid.
13. Postupak za pribavljanje farmaceutskog sastava neglikoziliranog rekombinantnog ljudskog G-CSF, naznačen time, da taj postupak obuhvaća sljedeće korake:
(a) formuliranje neglikoziliranog rekombinantnog ljudskog G-CSF s acetatnim ili glutamatnim puferom i sorbitolom, za dobivanje vodenog puferiranog G-CSF-sastava, pri čemu je količina tog G-CSF u rasponu od 0,1 mg/ml do 8,0 mg/ml i pri čemu spomenuti sastav ima volumen od 100 ml do 8 l;
(b) hlađenje G-CSF-sastava iz koraka (a) do temperature od -15°C ili ispod toga za dobivanje zamrznutog G-CSF-sastava;
(c) pohranjivanje G-CSF-sastava dobivenog u koraku (b) u zamrznutom stanju na vremenski period od najmanje mjesec dana;
(d) povećavanje temperature zamrznutog G-CSF-sastava iz koraka (c) na temperaturu u rasponu od 2°C do 8°C u vremenskom periodu namještenom tako da dopusti sastavu odmrzavanje te za dobivanje tekućeg sastava koji ima sadržaj G-CSF od najmanje 95% sadržaja sastava pribavljenog u koraku (a); i
(e) punjenje tekućeg sastava dobivenog u koraku (d) u primarna pakiranja za parenteralnu uporabu.
Applications Claiming Priority (4)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP10166915A EP2399572A1 (en) | 2010-06-22 | 2010-06-22 | Long-term storage of non-glycosylated recombinant human G-CSF |
| US36056210P | 2010-07-01 | 2010-07-01 | |
| PCT/EP2011/060454 WO2011161165A1 (en) | 2010-06-22 | 2011-06-22 | Long-term storage of non-glycosylated recombinant human g-csf |
| EP11726819.3A EP2585044B1 (en) | 2010-06-22 | 2011-06-22 | Long-term storage of non-glycosylated recombinant human g-csf |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20150372T1 true HRP20150372T1 (hr) | 2015-05-08 |
Family
ID=43414064
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20150372TT HRP20150372T1 (hr) | 2010-06-22 | 2015-03-30 | Dugotrajna pohrana neglikoziliranog rekombinantnog ljudskog g-csf |
Country Status (12)
| Country | Link |
|---|---|
| US (3) | US8449873B2 (hr) |
| EP (2) | EP2399572A1 (hr) |
| JP (1) | JP5837924B2 (hr) |
| CN (1) | CN102946863B (hr) |
| AU (1) | AU2011268944B2 (hr) |
| CA (1) | CA2802932C (hr) |
| ES (1) | ES2534334T3 (hr) |
| HK (1) | HK1181673A1 (hr) |
| HR (1) | HRP20150372T1 (hr) |
| RS (1) | RS53884B1 (hr) |
| SI (1) | SI2585044T1 (hr) |
| WO (1) | WO2011161165A1 (hr) |
Families Citing this family (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104906053B (zh) * | 2015-06-12 | 2018-01-16 | 北京四环生物制药有限公司 | 注射用重组人粒细胞刺激因子冻干粉针剂 |
Family Cites Families (14)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| GR871067B (en) | 1986-07-18 | 1987-11-19 | Chugai Pharmaceutical Co Ltd | Process for producing stable pharmaceutical preparation containing granulocyte colony stimulating factor |
| US5104651A (en) | 1988-12-16 | 1992-04-14 | Amgen Inc. | Stabilized hydrophobic protein formulations of g-csf |
| DE4014750A1 (de) | 1990-05-08 | 1991-11-14 | Boehringer Mannheim Gmbh | Muteine des granulozyten-stimulierenden faktors (g-csf) |
| JP2000247903A (ja) | 1999-03-01 | 2000-09-12 | Chugai Pharmaceut Co Ltd | 長期安定化製剤 |
| US6956023B1 (en) * | 2001-04-19 | 2005-10-18 | University Of Florida | Materials and methods for providing nutrition to neonates |
| GB0323968D0 (en) | 2003-10-13 | 2003-11-19 | Glaxosmithkline Biolog Sa | Immunogenic compositions |
| DE10348550A1 (de) | 2003-10-20 | 2005-06-16 | Hexal Biotech Forschungsgmbh | Stabile wässrige G-CSF-haltige Zusammensetzungen |
| EP1682184B1 (en) * | 2003-11-04 | 2013-10-16 | LEK Pharmaceuticals d.d. | Stable pharmaceutical composition comprising granulocyte-colony stimulating factor |
| WO2007034509A2 (en) | 2005-09-19 | 2007-03-29 | Zenotech Laboratories Limited | Recombinant granulocyte-colony stimulating factor formulation and process |
| DE202006020194U1 (de) | 2006-03-01 | 2007-12-06 | Bioceuticals Arzneimittel Ag | G-CSF-Flüssigformulierung |
| KR20090110349A (ko) * | 2007-02-16 | 2009-10-21 | 와이어쓰 | 소르비톨을 함유하는 단백질 제제 |
| CA2679551C (en) | 2007-04-05 | 2014-10-21 | Sandoz Ag | Stable aqueous g-csf formulations |
| MX2010002348A (es) * | 2007-08-27 | 2010-07-30 | Biogenerix Ag | Formulacion liquida de g-csf. |
| WO2011041376A1 (en) * | 2009-09-30 | 2011-04-07 | Prolong Pharmaceuticals | Modified granulocyte colony stimulating factor (g-csf) |
-
2010
- 2010-06-22 EP EP10166915A patent/EP2399572A1/en not_active Withdrawn
-
2011
- 2011-06-22 US US13/166,345 patent/US8449873B2/en active Active
- 2011-06-22 JP JP2013515886A patent/JP5837924B2/ja not_active Expired - Fee Related
- 2011-06-22 ES ES11726819.3T patent/ES2534334T3/es active Active
- 2011-06-22 SI SI201130441T patent/SI2585044T1/sl unknown
- 2011-06-22 CN CN201180031047.9A patent/CN102946863B/zh not_active Expired - Fee Related
- 2011-06-22 AU AU2011268944A patent/AU2011268944B2/en not_active Ceased
- 2011-06-22 US US13/805,180 patent/US8784794B2/en not_active Expired - Fee Related
- 2011-06-22 WO PCT/EP2011/060454 patent/WO2011161165A1/en active Application Filing
- 2011-06-22 RS RS20150167A patent/RS53884B1/en unknown
- 2011-06-22 CA CA2802932A patent/CA2802932C/en not_active Expired - Fee Related
- 2011-06-22 EP EP11726819.3A patent/EP2585044B1/en not_active Not-in-force
-
2013
- 2013-08-05 HK HK13109084.3A patent/HK1181673A1/xx not_active IP Right Cessation
-
2014
- 2014-06-17 US US14/306,689 patent/US9387233B2/en active Active
-
2015
- 2015-03-30 HR HRP20150372TT patent/HRP20150372T1/hr unknown
Also Published As
| Publication number | Publication date |
|---|---|
| US20140294756A1 (en) | 2014-10-02 |
| EP2585044B1 (en) | 2015-01-07 |
| EP2399572A1 (en) | 2011-12-28 |
| US8449873B2 (en) | 2013-05-28 |
| ES2534334T3 (es) | 2015-04-21 |
| AU2011268944A1 (en) | 2013-01-17 |
| JP5837924B2 (ja) | 2015-12-24 |
| US20120042613A1 (en) | 2012-02-23 |
| CA2802932A1 (en) | 2011-12-29 |
| CN102946863A (zh) | 2013-02-27 |
| CN102946863B (zh) | 2015-06-10 |
| US9387233B2 (en) | 2016-07-12 |
| SI2585044T1 (sl) | 2015-04-30 |
| CA2802932C (en) | 2018-03-06 |
| US20130164253A1 (en) | 2013-06-27 |
| RS53884B1 (en) | 2015-08-31 |
| US8784794B2 (en) | 2014-07-22 |
| EP2585044A1 (en) | 2013-05-01 |
| HK1181673A1 (en) | 2013-11-15 |
| JP2013529618A (ja) | 2013-07-22 |
| WO2011161165A1 (en) | 2011-12-29 |
| AU2011268944B2 (en) | 2014-05-01 |
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