NO322334B1 - Lyofilisert preparat av human benmorfogenetisk faktor MP52, og fremgangsmate for fremstilling av et lyofilisert preparat av human benmorfogenetisk faktor MP52 - Google Patents
Lyofilisert preparat av human benmorfogenetisk faktor MP52, og fremgangsmate for fremstilling av et lyofilisert preparat av human benmorfogenetisk faktor MP52 Download PDFInfo
- Publication number
- NO322334B1 NO322334B1 NO19993702A NO993702A NO322334B1 NO 322334 B1 NO322334 B1 NO 322334B1 NO 19993702 A NO19993702 A NO 19993702A NO 993702 A NO993702 A NO 993702A NO 322334 B1 NO322334 B1 NO 322334B1
- Authority
- NO
- Norway
- Prior art keywords
- bone morphogenetic
- human bone
- morphogenetic factor
- lyophilized preparation
- mannitol
- Prior art date
Links
- 108010007726 Bone Morphogenetic Proteins Proteins 0.000 title claims description 40
- 102000007350 Bone Morphogenetic Proteins Human genes 0.000 title claims description 40
- 101100472152 Trypanosoma brucei brucei (strain 927/4 GUTat10.1) REL1 gene Proteins 0.000 title claims description 40
- 238000002360 preparation method Methods 0.000 title claims description 35
- 238000000034 method Methods 0.000 title claims description 6
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 claims description 24
- 235000010355 mannitol Nutrition 0.000 claims description 22
- 229930195725 Mannitol Natural products 0.000 claims description 20
- 239000000594 mannitol Substances 0.000 claims description 20
- 239000000243 solution Substances 0.000 claims description 11
- 238000004108 freeze drying Methods 0.000 claims description 10
- 238000004519 manufacturing process Methods 0.000 claims description 5
- 238000002156 mixing Methods 0.000 claims description 5
- 238000010353 genetic engineering Methods 0.000 claims description 4
- 239000000203 mixture Substances 0.000 claims description 4
- 239000011259 mixed solution Substances 0.000 claims description 3
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 12
- 238000003860 storage Methods 0.000 description 8
- 230000011164 ossification Effects 0.000 description 7
- 239000000047 product Substances 0.000 description 7
- 239000003708 ampul Substances 0.000 description 5
- 238000001962 electrophoresis Methods 0.000 description 4
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 description 3
- 239000012153 distilled water Substances 0.000 description 3
- 238000002347 injection Methods 0.000 description 3
- 239000007924 injection Substances 0.000 description 3
- 239000000825 pharmaceutical preparation Substances 0.000 description 3
- 229940127557 pharmaceutical product Drugs 0.000 description 3
- 238000013112 stability test Methods 0.000 description 3
- 238000012360 testing method Methods 0.000 description 3
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 description 2
- 102000004887 Transforming Growth Factor beta Human genes 0.000 description 2
- 108090001012 Transforming Growth Factor beta Proteins 0.000 description 2
- 235000001014 amino acid Nutrition 0.000 description 2
- 150000001413 amino acids Chemical class 0.000 description 2
- 239000007864 aqueous solution Substances 0.000 description 2
- 150000001720 carbohydrates Chemical class 0.000 description 2
- 239000000706 filtrate Substances 0.000 description 2
- 238000005259 measurement Methods 0.000 description 2
- 150000005846 sugar alcohols Polymers 0.000 description 2
- ZRKFYGHZFMAOKI-QMGMOQQFSA-N tgfbeta Chemical compound C([C@H](NC(=O)[C@H](C(C)C)NC(=O)CNC(=O)[C@H](CCC(O)=O)NC(=O)[C@H](CCCNC(N)=N)NC(=O)[C@H](CC(N)=O)NC(=O)[C@H](CC(C)C)NC(=O)[C@H]([C@@H](C)O)NC(=O)[C@H](CCC(O)=O)NC(=O)[C@H]([C@@H](C)O)NC(=O)[C@H](CC(C)C)NC(=O)CNC(=O)[C@H](C)NC(=O)[C@H](CO)NC(=O)[C@H](CCC(N)=O)NC(=O)[C@@H](NC(=O)[C@H](C)NC(=O)[C@H](C)NC(=O)[C@@H](NC(=O)[C@H](CC(C)C)NC(=O)[C@@H](N)CCSC)C(C)C)[C@@H](C)CC)C(=O)N[C@@H]([C@@H](C)O)C(=O)N[C@@H](C(C)C)C(=O)N[C@@H](CC=1C=CC=CC=1)C(=O)N[C@@H](C)C(=O)N1[C@@H](CCC1)C(=O)N[C@@H]([C@@H](C)O)C(=O)N[C@@H](CC(N)=O)C(=O)N[C@@H](CCC(O)=O)C(=O)N[C@@H](C)C(=O)N[C@@H](CC=1C=CC=CC=1)C(=O)N[C@@H](CCCNC(N)=N)C(=O)N[C@@H](C)C(=O)N[C@@H](CC(C)C)C(=O)N1[C@@H](CCC1)C(=O)N1[C@@H](CCC1)C(=O)N[C@@H](CCCNC(N)=N)C(=O)N[C@@H](CCC(O)=O)C(=O)N[C@@H](CCCNC(N)=N)C(=O)N[C@@H](CO)C(=O)N[C@@H](CCCNC(N)=N)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CC(C)C)C(O)=O)C1=CC=C(O)C=C1 ZRKFYGHZFMAOKI-QMGMOQQFSA-N 0.000 description 2
- 108010049931 Bone Morphogenetic Protein 2 Proteins 0.000 description 1
- 102100024506 Bone morphogenetic protein 2 Human genes 0.000 description 1
- 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 description 1
- 229920002307 Dextran Polymers 0.000 description 1
- QNAYBMKLOCPYGJ-REOHCLBHSA-N L-alanine Chemical compound C[C@H](N)C(O)=O QNAYBMKLOCPYGJ-REOHCLBHSA-N 0.000 description 1
- KDXKERNSBIXSRK-YFKPBYRVSA-N L-lysine Chemical compound NCCCC[C@H](N)C(O)=O KDXKERNSBIXSRK-YFKPBYRVSA-N 0.000 description 1
- KZSNJWFQEVHDMF-BYPYZUCNSA-N L-valine Chemical compound CC(C)[C@H](N)C(O)=O KZSNJWFQEVHDMF-BYPYZUCNSA-N 0.000 description 1
- 239000004472 Lysine Substances 0.000 description 1
- KDXKERNSBIXSRK-UHFFFAOYSA-N Lysine Natural products NCCCCC(N)C(O)=O KDXKERNSBIXSRK-UHFFFAOYSA-N 0.000 description 1
- 229930006000 Sucrose Natural products 0.000 description 1
- CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 description 1
- KZSNJWFQEVHDMF-UHFFFAOYSA-N Valine Natural products CC(C)C(N)C(O)=O KZSNJWFQEVHDMF-UHFFFAOYSA-N 0.000 description 1
- 239000002253 acid Substances 0.000 description 1
- 239000000654 additive Substances 0.000 description 1
- 235000004279 alanine Nutrition 0.000 description 1
- 230000005540 biological transmission Effects 0.000 description 1
- 230000015572 biosynthetic process Effects 0.000 description 1
- 239000000872 buffer Substances 0.000 description 1
- 239000002299 complementary DNA Substances 0.000 description 1
- 238000007796 conventional method Methods 0.000 description 1
- 238000011161 development Methods 0.000 description 1
- 238000011038 discontinuous diafiltration by volume reduction Methods 0.000 description 1
- 238000011156 evaluation Methods 0.000 description 1
- 238000011049 filling Methods 0.000 description 1
- 238000001914 filtration Methods 0.000 description 1
- 235000013305 food Nutrition 0.000 description 1
- 230000009931 harmful effect Effects 0.000 description 1
- 230000007774 longterm Effects 0.000 description 1
- 239000012528 membrane Substances 0.000 description 1
- 230000001002 morphogenetic effect Effects 0.000 description 1
- 230000007935 neutral effect Effects 0.000 description 1
- 230000003287 optical effect Effects 0.000 description 1
- 239000000843 powder Substances 0.000 description 1
- 235000018102 proteins Nutrition 0.000 description 1
- 102000004169 proteins and genes Human genes 0.000 description 1
- 108090000623 proteins and genes Proteins 0.000 description 1
- 238000011160 research Methods 0.000 description 1
- 239000000600 sorbitol Substances 0.000 description 1
- 238000010186 staining Methods 0.000 description 1
- 238000010561 standard procedure Methods 0.000 description 1
- 239000005720 sucrose Substances 0.000 description 1
- 230000001225 therapeutic effect Effects 0.000 description 1
- 239000004474 valine Substances 0.000 description 1
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
- A61K38/18—Growth factors; Growth regulators
-
- 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
- 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
- A61K38/18—Growth factors; Growth regulators
- A61K38/1875—Bone morphogenic factor; Osteogenins; Osteogenic factor; Bone-inducing factor
-
- 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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P19/00—Drugs for skeletal disorders
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Immunology (AREA)
- Gastroenterology & Hepatology (AREA)
- Zoology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Physical Education & Sports Medicine (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Organic Chemistry (AREA)
- Biochemistry (AREA)
- Molecular Biology (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Dermatology (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicinal Preparation (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP1634997 | 1997-01-30 | ||
| PCT/JP1998/000371 WO1998033514A1 (fr) | 1997-01-30 | 1998-01-29 | Composition lyophilisee de mp52 humaine de proteines morphogenetiques osseuses |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| NO993702D0 NO993702D0 (no) | 1999-07-29 |
| NO993702L NO993702L (no) | 1999-09-29 |
| NO322334B1 true NO322334B1 (no) | 2006-09-18 |
Family
ID=11913900
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| NO19993702A NO322334B1 (no) | 1997-01-30 | 1999-07-29 | Lyofilisert preparat av human benmorfogenetisk faktor MP52, og fremgangsmate for fremstilling av et lyofilisert preparat av human benmorfogenetisk faktor MP52 |
Country Status (22)
| Country | Link |
|---|---|
| EP (1) | EP0972520B9 (sr) |
| JP (1) | JP4209948B2 (sr) |
| KR (1) | KR100548107B1 (sr) |
| CN (1) | CN1152712C (sr) |
| AP (1) | AP983A (sr) |
| AT (1) | ATE302021T1 (sr) |
| AU (1) | AU737595B2 (sr) |
| BR (1) | BR9807537B1 (sr) |
| CA (1) | CA2278546C (sr) |
| DE (1) | DE69831223T9 (sr) |
| DK (1) | DK0972520T3 (sr) |
| EA (1) | EA001579B1 (sr) |
| ES (1) | ES2244043T3 (sr) |
| HU (1) | HU226554B1 (sr) |
| IL (2) | IL130967A0 (sr) |
| NO (1) | NO322334B1 (sr) |
| NZ (1) | NZ336509A (sr) |
| PL (1) | PL189381B1 (sr) |
| RS (1) | RS49691B (sr) |
| SI (1) | SI0972520T1 (sr) |
| TR (1) | TR199901832T2 (sr) |
| WO (1) | WO1998033514A1 (sr) |
Families Citing this family (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP4388602B2 (ja) † | 1997-02-07 | 2009-12-24 | ストライカー コーポレイション | マトリクスを含まない骨形成デバイス、移植片、およびその使用方法 |
| WO2003030873A1 (en) * | 2001-10-09 | 2003-04-17 | Cellfactors Plc | Therapeutic biological product and method for formation of new vascularised bone |
| CA2466947C (en) | 2001-11-19 | 2012-05-22 | Scil Technology Gmbh | A homogeneously coated device having osteoinductive and osteoconductive properties |
| ATE322916T1 (de) | 2002-09-10 | 2006-04-15 | Scil Technology Gmbh | Unter verringerter sauerstoffkonzentration mit einem osteoinduktiven protein beschichtetes metallimplantat |
| EP1651272A1 (en) * | 2003-08-05 | 2006-05-03 | Fuji Photo Film B.V. | Use of recombinant or synthetic gelatin as a stabiliser in vaccines |
| CA2545458A1 (en) * | 2003-11-10 | 2005-05-26 | Arriva-Prometic Inc. | Dry recombinant human alpha 1-antitrypsin formulation |
| JP4944010B2 (ja) | 2004-03-10 | 2012-05-30 | サイル テクノロジー ゲーエムベーハー | コーティングされたインプラント、その製造および使用 |
| US10360287B2 (en) | 2015-05-22 | 2019-07-23 | Microsoft Technology Licensing, Llc | Unified messaging platform and interface for providing user callouts |
| US20160344677A1 (en) | 2015-05-22 | 2016-11-24 | Microsoft Technology Licensing, Llc | Unified messaging platform for providing interactive semantic objects |
Family Cites Families (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE3273597D1 (en) * | 1981-11-28 | 1986-11-06 | Sunstar Kk | Pharmaceutical composition containing interferon in stable state |
| US5037644A (en) * | 1986-10-27 | 1991-08-06 | Cetus Corporation | Pharmaceutical compositions of recombinant interleukin-2 and formulation processes |
| AU663328B2 (en) * | 1991-06-21 | 1995-10-05 | Genetics Institute, Llc | Pharmaceutical formulations of osteogenic proteins |
| JP2966592B2 (ja) * | 1991-07-20 | 1999-10-25 | 萩原 義秀 | 安定化されたヒトモノクローナル抗体製剤 |
| UA48105C2 (uk) * | 1992-02-12 | 2002-08-15 | Біофарм Гезельшафт Цур Біотехнологішен Ентвіклунг Вон Фармака Мбх | ФРАГМЕНТ ДНК, ЯКИЙ КОДУЄ БІЛОК РОДИНИ TGF-<font face="Symbol">b</font> (ВАРІАНТИ), РЕКОМБІНАНТНА МОЛЕКУЛА ДНК (ВАРІАНТИ), КЛІТИНА-ХАЗЯЇН (ВАРІАНТИ), СПОСІБ ОДЕРЖАННЯ БІЛКУ РОДИНИ TGF-<font face="Symbol">b</font> (ВАРІАНТИ), БІЛОК РОДИНИ TGF-<font face="Symbol">b</font> (ВАРІАНТИ), ФАРМАЦЕВТИЧНА КОМПОЗИЦІЯ (ВАРІАНТИ), АНТИТІЛО АБО ФРАГМЕНТ АНТИТІЛА (ВАРІАНТИ), МОЛЕКУЛА КДНК (ВАРІАНТИ) |
| CA2093836A1 (en) * | 1992-04-24 | 1993-10-25 | Wayne Gombotz | Biodegradable tgf-.beta. delivery system for bone regeneration |
| DE4239877C1 (de) * | 1992-11-27 | 1994-03-17 | Boehringer Ingelheim Int | Stabilisierte Superoxid-Dismutase (SOD)-Zusammensetzung |
| EP0814841B1 (en) * | 1995-03-21 | 2001-12-05 | Applied Research Systems ARS Holding N.V. | Hcg liquid formulations |
| US7235527B2 (en) * | 1995-04-19 | 2007-06-26 | Biopharm Gesellschaft Zur Biotechnologieschen Entwicklung Von Pharmaka Mbh | Protein and process for producing the same |
-
1998
- 1998-01-29 PL PL98334852A patent/PL189381B1/pl not_active IP Right Cessation
- 1998-01-29 AP APAP/P/1999/001602A patent/AP983A/en active
- 1998-01-29 AU AU56791/98A patent/AU737595B2/en not_active Ceased
- 1998-01-29 EA EA199900694A patent/EA001579B1/ru not_active IP Right Cessation
- 1998-01-29 IL IL13096798A patent/IL130967A0/xx active IP Right Grant
- 1998-01-29 BR BRPI9807537-3A patent/BR9807537B1/pt not_active IP Right Cessation
- 1998-01-29 NZ NZ336509A patent/NZ336509A/xx not_active IP Right Cessation
- 1998-01-29 DK DK98901044T patent/DK0972520T3/da active
- 1998-01-29 WO PCT/JP1998/000371 patent/WO1998033514A1/ja active IP Right Grant
- 1998-01-29 AT AT98901044T patent/ATE302021T1/de active
- 1998-01-29 HU HU0002386A patent/HU226554B1/hu not_active IP Right Cessation
- 1998-01-29 JP JP53271798A patent/JP4209948B2/ja not_active Expired - Fee Related
- 1998-01-29 EP EP98901044A patent/EP0972520B9/en not_active Expired - Lifetime
- 1998-01-29 KR KR1019997006833A patent/KR100548107B1/ko not_active IP Right Cessation
- 1998-01-29 RS YUP-349/99A patent/RS49691B/sr unknown
- 1998-01-29 SI SI9830798T patent/SI0972520T1/sl unknown
- 1998-01-29 ES ES98901044T patent/ES2244043T3/es not_active Expired - Lifetime
- 1998-01-29 CA CA002278546A patent/CA2278546C/en not_active Expired - Fee Related
- 1998-01-29 DE DE69831223T patent/DE69831223T9/de active Active
- 1998-01-29 CN CNB988019841A patent/CN1152712C/zh not_active Expired - Fee Related
- 1998-01-29 TR TR1999/01832T patent/TR199901832T2/xx unknown
-
1999
- 1999-07-15 IL IL130967A patent/IL130967A/en not_active IP Right Cessation
- 1999-07-29 NO NO19993702A patent/NO322334B1/no not_active IP Right Cessation
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| MM1K | Lapsed by not paying the annual fees |