JP4036494B2 - ウイルスを不活化した静脈内注射可能な免疫血清グロブリンの調製 - Google Patents
ウイルスを不活化した静脈内注射可能な免疫血清グロブリンの調製 Download PDFInfo
- Publication number
- JP4036494B2 JP4036494B2 JP26508496A JP26508496A JP4036494B2 JP 4036494 B2 JP4036494 B2 JP 4036494B2 JP 26508496 A JP26508496 A JP 26508496A JP 26508496 A JP26508496 A JP 26508496A JP 4036494 B2 JP4036494 B2 JP 4036494B2
- Authority
- JP
- Japan
- Prior art keywords
- solution
- aca
- incubation
- tnbp
- antibody solution
- 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.)
- Expired - Lifetime
Links
- 241000700605 Viruses Species 0.000 title claims abstract description 33
- 238000002360 preparation method Methods 0.000 title description 26
- 108010045362 Serum Globulins Proteins 0.000 title description 14
- 102000005686 Serum Globulins Human genes 0.000 title description 14
- 238000000034 method Methods 0.000 claims abstract description 76
- 230000000694 effects Effects 0.000 claims abstract description 30
- 230000002391 anti-complement effect Effects 0.000 claims abstract description 24
- 108010008730 anticomplement Proteins 0.000 claims abstract description 24
- 230000003612 virological effect Effects 0.000 claims abstract description 12
- 239000004094 surface-active agent Substances 0.000 claims description 29
- 108010074605 gamma-Globulins Proteins 0.000 claims description 7
- 229910019142 PO4 Inorganic materials 0.000 claims description 5
- 238000001514 detection method Methods 0.000 claims description 4
- NBIIXXVUZAFLBC-UHFFFAOYSA-K phosphate Chemical compound [O-]P([O-])([O-])=O NBIIXXVUZAFLBC-UHFFFAOYSA-K 0.000 claims description 4
- 239000010452 phosphate Substances 0.000 claims description 4
- 241000894007 species Species 0.000 claims description 4
- 238000004519 manufacturing process Methods 0.000 claims description 3
- 210000004779 membrane envelope Anatomy 0.000 claims description 2
- 235000021317 phosphate Nutrition 0.000 claims 2
- 150000003013 phosphoric acid derivatives Chemical class 0.000 claims 1
- 238000011534 incubation Methods 0.000 abstract description 47
- STCOOQWBFONSKY-UHFFFAOYSA-N tributyl phosphate Chemical compound CCCCOP(=O)(OCCCC)OCCCC STCOOQWBFONSKY-UHFFFAOYSA-N 0.000 abstract description 43
- 230000002779 inactivation Effects 0.000 abstract description 27
- 238000011282 treatment Methods 0.000 abstract description 15
- NRHMKIHPTBHXPF-TUJRSCDTSA-M sodium cholate Chemical compound [Na+].C([C@H]1C[C@H]2O)[C@H](O)CC[C@]1(C)[C@@H]1[C@@H]2[C@@H]2CC[C@H]([C@@H](CCC([O-])=O)C)[C@@]2(C)[C@@H](O)C1 NRHMKIHPTBHXPF-TUJRSCDTSA-M 0.000 abstract description 5
- 239000003599 detergent Substances 0.000 abstract description 3
- -1 sodium cholate Chemical compound 0.000 abstract description 2
- 239000000243 solution Substances 0.000 description 49
- 229940099352 cholate Drugs 0.000 description 30
- BHQCQFFYRZLCQQ-OELDTZBJSA-N cholic acid Chemical compound C([C@H]1C[C@H]2O)[C@H](O)CC[C@]1(C)[C@@H]1[C@@H]2[C@@H]2CC[C@H]([C@@H](CCC(O)=O)C)[C@@]2(C)[C@@H](O)C1 BHQCQFFYRZLCQQ-OELDTZBJSA-N 0.000 description 30
- 239000002904 solvent Substances 0.000 description 24
- 230000008569 process Effects 0.000 description 18
- 235000018102 proteins Nutrition 0.000 description 16
- 102000004169 proteins and genes Human genes 0.000 description 16
- 108090000623 proteins and genes Proteins 0.000 description 16
- 239000000047 product Substances 0.000 description 15
- 230000007423 decrease Effects 0.000 description 14
- 239000000203 mixture Substances 0.000 description 13
- 230000000295 complement effect Effects 0.000 description 12
- 239000007858 starting material Substances 0.000 description 12
- 238000002474 experimental method Methods 0.000 description 11
- 238000001990 intravenous administration Methods 0.000 description 10
- 239000000463 material Substances 0.000 description 10
- 238000009472 formulation Methods 0.000 description 9
- DHMQDGOQFOQNFH-UHFFFAOYSA-N Glycine Chemical compound NCC(O)=O DHMQDGOQFOQNFH-UHFFFAOYSA-N 0.000 description 8
- 239000012460 protein solution Substances 0.000 description 7
- OWEGMIWEEQEYGQ-UHFFFAOYSA-N 100676-05-9 Natural products OC1C(O)C(O)C(CO)OC1OCC1C(O)C(O)C(O)C(OC2C(OC(O)C(O)C2O)CO)O1 OWEGMIWEEQEYGQ-UHFFFAOYSA-N 0.000 description 6
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 description 6
- GUBGYTABKSRVRQ-PICCSMPSSA-N Maltose Natural products O[C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@@H](CO)OC(O)[C@H](O)[C@H]1O GUBGYTABKSRVRQ-PICCSMPSSA-N 0.000 description 6
- 238000004128 high performance liquid chromatography Methods 0.000 description 6
- 230000009467 reduction Effects 0.000 description 6
- 239000000706 filtrate Substances 0.000 description 5
- 238000001914 filtration Methods 0.000 description 5
- 238000010253 intravenous injection Methods 0.000 description 5
- 235000010482 polyoxyethylene sorbitan monooleate Nutrition 0.000 description 5
- 229920000053 polysorbate 80 Polymers 0.000 description 5
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 5
- 239000004471 Glycine Substances 0.000 description 4
- 239000010836 blood and blood product Substances 0.000 description 4
- 229940125691 blood product Drugs 0.000 description 4
- 210000003743 erythrocyte Anatomy 0.000 description 4
- 238000005194 fractionation Methods 0.000 description 4
- 150000002632 lipids Chemical class 0.000 description 4
- 239000011347 resin Substances 0.000 description 4
- 229920005989 resin Polymers 0.000 description 4
- 210000002966 serum Anatomy 0.000 description 4
- 241000710780 Bovine viral diarrhea virus 1 Species 0.000 description 3
- 108060003951 Immunoglobulin Proteins 0.000 description 3
- 230000002776 aggregation Effects 0.000 description 3
- 238000004220 aggregation Methods 0.000 description 3
- 238000003556 assay Methods 0.000 description 3
- 235000014633 carbohydrates Nutrition 0.000 description 3
- 150000001720 carbohydrates Chemical class 0.000 description 3
- 238000004587 chromatography analysis Methods 0.000 description 3
- 238000007796 conventional method Methods 0.000 description 3
- 230000009089 cytolysis Effects 0.000 description 3
- 230000002209 hydrophobic effect Effects 0.000 description 3
- 230000000521 hyperimmunizing effect Effects 0.000 description 3
- 102000018358 immunoglobulin Human genes 0.000 description 3
- 238000013101 initial test Methods 0.000 description 3
- 238000007918 intramuscular administration Methods 0.000 description 3
- 238000003860 storage Methods 0.000 description 3
- 238000000108 ultra-filtration Methods 0.000 description 3
- 206010067484 Adverse reaction Diseases 0.000 description 2
- 241000713772 Human immunodeficiency virus 1 Species 0.000 description 2
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 description 2
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 description 2
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 description 2
- 230000002411 adverse Effects 0.000 description 2
- 230000006838 adverse reaction Effects 0.000 description 2
- 150000001413 amino acids Chemical class 0.000 description 2
- 238000013459 approach Methods 0.000 description 2
- 239000007864 aqueous solution Substances 0.000 description 2
- 210000004369 blood Anatomy 0.000 description 2
- 239000008280 blood Substances 0.000 description 2
- 230000001419 dependent effect Effects 0.000 description 2
- 238000011026 diafiltration Methods 0.000 description 2
- 201000010099 disease Diseases 0.000 description 2
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 2
- 238000001704 evaporation Methods 0.000 description 2
- 230000008020 evaporation Effects 0.000 description 2
- 239000012467 final product Substances 0.000 description 2
- 238000002347 injection Methods 0.000 description 2
- 239000007924 injection Substances 0.000 description 2
- 239000007927 intramuscular injection Substances 0.000 description 2
- 238000002156 mixing Methods 0.000 description 2
- 230000004048 modification Effects 0.000 description 2
- 238000012986 modification Methods 0.000 description 2
- 239000000843 powder Substances 0.000 description 2
- 238000001223 reverse osmosis Methods 0.000 description 2
- 239000011734 sodium Substances 0.000 description 2
- 238000000859 sublimation Methods 0.000 description 2
- 230000008022 sublimation Effects 0.000 description 2
- 108010032597 Cohn fraction II Proteins 0.000 description 1
- 108010044316 Cohn fraction III Proteins 0.000 description 1
- 102000006395 Globulins Human genes 0.000 description 1
- 108010044091 Globulins Proteins 0.000 description 1
- 206010018910 Haemolysis Diseases 0.000 description 1
- 108010054147 Hemoglobins Proteins 0.000 description 1
- 102000001554 Hemoglobins Human genes 0.000 description 1
- 208000005176 Hepatitis C Diseases 0.000 description 1
- 239000004793 Polystyrene Substances 0.000 description 1
- 206010037742 Rabies Diseases 0.000 description 1
- 206010043376 Tetanus Diseases 0.000 description 1
- 239000002253 acid Substances 0.000 description 1
- 238000001042 affinity chromatography Methods 0.000 description 1
- 238000004458 analytical method Methods 0.000 description 1
- 230000008901 benefit Effects 0.000 description 1
- 230000004071 biological effect Effects 0.000 description 1
- 239000002981 blocking agent Substances 0.000 description 1
- 210000004027 cell Anatomy 0.000 description 1
- 238000006243 chemical reaction Methods 0.000 description 1
- 239000002812 cholic acid derivative Substances 0.000 description 1
- 230000004154 complement system Effects 0.000 description 1
- 230000001143 conditioned effect Effects 0.000 description 1
- 238000011109 contamination Methods 0.000 description 1
- 230000003247 decreasing effect Effects 0.000 description 1
- 230000036425 denaturation Effects 0.000 description 1
- 238000004925 denaturation Methods 0.000 description 1
- 238000009826 distribution Methods 0.000 description 1
- 230000007717 exclusion Effects 0.000 description 1
- 238000000605 extraction Methods 0.000 description 1
- 239000013020 final formulation Substances 0.000 description 1
- 238000001879 gelation Methods 0.000 description 1
- 230000008588 hemolysis Effects 0.000 description 1
- 208000006454 hepatitis Diseases 0.000 description 1
- 231100000283 hepatitis Toxicity 0.000 description 1
- 230000028993 immune response Effects 0.000 description 1
- 230000036039 immunity Effects 0.000 description 1
- 229940027941 immunoglobulin g Drugs 0.000 description 1
- 229940072221 immunoglobulins Drugs 0.000 description 1
- 238000001727 in vivo Methods 0.000 description 1
- 230000000415 inactivating effect Effects 0.000 description 1
- 238000010348 incorporation Methods 0.000 description 1
- 208000015181 infectious disease Diseases 0.000 description 1
- 230000005764 inhibitory process Effects 0.000 description 1
- 238000010255 intramuscular injection Methods 0.000 description 1
- 238000004255 ion exchange chromatography Methods 0.000 description 1
- 238000002955 isolation Methods 0.000 description 1
- 239000008176 lyophilized powder Substances 0.000 description 1
- 230000001404 mediated effect Effects 0.000 description 1
- 239000000178 monomer Substances 0.000 description 1
- 239000002245 particle Substances 0.000 description 1
- 239000000825 pharmaceutical preparation Substances 0.000 description 1
- 230000004962 physiological condition Effects 0.000 description 1
- 229920000642 polymer Polymers 0.000 description 1
- 239000000244 polyoxyethylene sorbitan monooleate Substances 0.000 description 1
- 229940068968 polysorbate 80 Drugs 0.000 description 1
- 229920002223 polystyrene Polymers 0.000 description 1
- 238000011533 pre-incubation Methods 0.000 description 1
- 238000001556 precipitation Methods 0.000 description 1
- 235000004252 protein component Nutrition 0.000 description 1
- 230000017854 proteolysis Effects 0.000 description 1
- 230000009291 secondary effect Effects 0.000 description 1
- 238000004062 sedimentation Methods 0.000 description 1
- 239000000377 silicon dioxide Substances 0.000 description 1
- 239000011780 sodium chloride Substances 0.000 description 1
- 239000007787 solid Substances 0.000 description 1
- 230000006641 stabilisation Effects 0.000 description 1
- 238000011105 stabilization Methods 0.000 description 1
- 239000008174 sterile solution Substances 0.000 description 1
- 238000003756 stirring Methods 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
- 238000012360 testing method Methods 0.000 description 1
- 238000005199 ultracentrifugation Methods 0.000 description 1
- 241001430294 unidentified retrovirus Species 0.000 description 1
- 229960005486 vaccine Drugs 0.000 description 1
- 230000003253 viricidal effect Effects 0.000 description 1
- 239000008215 water for injection Substances 0.000 description 1
Images
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
- A61L2/0005—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts
- A61L2/0082—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts using chemical substances
- A61L2/0088—Liquid substances
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
- C07K16/06—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies from serum
- C07K16/065—Purification, fragmentation
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Molecular Biology (AREA)
- Organic Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Biomedical Technology (AREA)
- Biochemistry (AREA)
- Animal Behavior & Ethology (AREA)
- Engineering & Computer Science (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Immunology (AREA)
- Epidemiology (AREA)
- Biophysics (AREA)
- Genetics & Genomics (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Medicinal Preparation (AREA)
- Peptides Or Proteins (AREA)
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US08/532,211 US6686191B1 (en) | 1995-09-22 | 1995-09-22 | Preparation of virally inactivated intravenously injectable immune serum globulin |
| US532211 | 1995-09-22 |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| JPH09124507A JPH09124507A (ja) | 1997-05-13 |
| JPH09124507A5 JPH09124507A5 (enExample) | 2004-09-02 |
| JP4036494B2 true JP4036494B2 (ja) | 2008-01-23 |
Family
ID=24120836
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP26508496A Expired - Lifetime JP4036494B2 (ja) | 1995-09-22 | 1996-09-17 | ウイルスを不活化した静脈内注射可能な免疫血清グロブリンの調製 |
Country Status (10)
| Country | Link |
|---|---|
| US (1) | US6686191B1 (enExample) |
| EP (2) | EP1356829A3 (enExample) |
| JP (1) | JP4036494B2 (enExample) |
| AT (1) | ATE257016T1 (enExample) |
| AU (1) | AU709608B2 (enExample) |
| CA (1) | CA2185859C (enExample) |
| DE (1) | DE69631229T2 (enExample) |
| DK (1) | DK0764447T3 (enExample) |
| ES (1) | ES2213760T3 (enExample) |
| PT (1) | PT764447E (enExample) |
Families Citing this family (14)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO1998044948A2 (en) * | 1997-04-07 | 1998-10-15 | Cangene Corporation | Intravenous immune globulin formulation containing a non-ionic surface active agent with improved pharmacokinetic properties |
| AT405608B (de) * | 1997-04-08 | 1999-10-25 | Immuno Ag | Verfahren zur inaktivierung von pathogenen, insbesondere von viren, in einem biologischen material |
| BR9807936A (pt) | 1997-04-08 | 2000-02-22 | Baxter Ag | Preparação farmacêutica imuno-tolerante de complexo de pró-trombina, processo para a produção de uma preparação, e, utilização de uma preparação |
| US6717116B1 (en) * | 1999-08-10 | 2004-04-06 | Ibiden Co., Ltd. | Semiconductor production device ceramic plate |
| US8703126B2 (en) | 2000-10-12 | 2014-04-22 | Genentech, Inc. | Reduced-viscosity concentrated protein formulations |
| IL155002A0 (en) | 2000-10-12 | 2003-10-31 | Genentech Inc | Reduced-viscosity concentrated protein formulations |
| KR100791502B1 (ko) * | 2006-09-29 | 2008-01-03 | 한스바이오메드 주식회사 | 바이러스 불활화된 무세포 인체 이식재 생산방법 |
| EP2077118A1 (en) * | 2008-01-07 | 2009-07-08 | Gwo Rei Biomedical Technology Corp. | Clottable concentrate of platelet growth factors and preparation method thereof |
| TW201039854A (en) | 2009-03-06 | 2010-11-16 | Genentech Inc | Antibody formulation |
| LT3345615T (lt) | 2010-03-01 | 2020-02-10 | Bayer Healthcare Llc | Optimizuoti monokloniniai antikūnai prieš audinių faktoriaus kelio slopiklį (tfpi) |
| CN102357259A (zh) * | 2011-07-28 | 2012-02-22 | 王珊珊 | 一种生物蛋白海绵及其制备方法 |
| EP3981873A1 (en) | 2012-06-29 | 2022-04-13 | EMD Millipore Corporation | Methods for inactivating viruses during a protein purification process |
| US8613919B1 (en) | 2012-08-31 | 2013-12-24 | Bayer Healthcare, Llc | High concentration antibody and protein formulations |
| US9592297B2 (en) | 2012-08-31 | 2017-03-14 | Bayer Healthcare Llc | Antibody and protein formulations |
Family Cites Families (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4396608A (en) * | 1981-08-24 | 1983-08-02 | Cutter Laboratories | Intravenously injectable immune serum globulin |
| US4540573A (en) * | 1983-07-14 | 1985-09-10 | New York Blood Center, Inc. | Undenatured virus-free biologically active protein derivatives |
| US4762714A (en) * | 1986-04-08 | 1988-08-09 | Miles Laboratories, Inc. | Preparation of retrovirus-free immunoglobulins |
| GB8628104D0 (en) * | 1986-11-25 | 1986-12-31 | Connaught Lab | Pasteurization of immunoglobin solutions |
| EP0523406B1 (en) * | 1991-07-05 | 1998-12-09 | Bayer Corporation | Use of tri(n-butyl) phosphate at low pH in solutions of biologically active proteins for enhanced virucidal activity |
-
1995
- 1995-09-22 US US08/532,211 patent/US6686191B1/en not_active Expired - Fee Related
-
1996
- 1996-09-10 ES ES96114439T patent/ES2213760T3/es not_active Expired - Lifetime
- 1996-09-10 EP EP03016677A patent/EP1356829A3/en not_active Withdrawn
- 1996-09-10 DK DK96114439T patent/DK0764447T3/da active
- 1996-09-10 EP EP96114439A patent/EP0764447B1/en not_active Expired - Lifetime
- 1996-09-10 AT AT96114439T patent/ATE257016T1/de active
- 1996-09-10 PT PT96114439T patent/PT764447E/pt unknown
- 1996-09-10 DE DE69631229T patent/DE69631229T2/de not_active Expired - Lifetime
- 1996-09-17 JP JP26508496A patent/JP4036494B2/ja not_active Expired - Lifetime
- 1996-09-18 AU AU65690/96A patent/AU709608B2/en not_active Expired
- 1996-09-18 CA CA2185859A patent/CA2185859C/en not_active Expired - Fee Related
Also Published As
| Publication number | Publication date |
|---|---|
| EP1356829A2 (en) | 2003-10-29 |
| DE69631229T2 (de) | 2004-12-02 |
| EP0764447B1 (en) | 2004-01-02 |
| EP0764447A2 (en) | 1997-03-26 |
| ATE257016T1 (de) | 2004-01-15 |
| AU6569096A (en) | 1997-03-27 |
| AU709608B2 (en) | 1999-09-02 |
| EP1356829A3 (en) | 2003-12-17 |
| CA2185859A1 (en) | 1997-03-23 |
| EP0764447A3 (en) | 1997-07-30 |
| ES2213760T3 (es) | 2004-09-01 |
| PT764447E (pt) | 2004-04-30 |
| CA2185859C (en) | 2011-04-19 |
| JPH09124507A (ja) | 1997-05-13 |
| US6686191B1 (en) | 2004-02-03 |
| DE69631229D1 (de) | 2004-02-05 |
| DK0764447T3 (da) | 2004-05-03 |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| EP0073371B1 (en) | Intravenously injectable immune serum globulin and method of preparing same | |
| JP6612182B2 (ja) | 免疫グロブリン組成物を調製するためのプロセス | |
| US4499073A (en) | Intravenously injectable immune serum globulin | |
| JP4036494B2 (ja) | ウイルスを不活化した静脈内注射可能な免疫血清グロブリンの調製 | |
| US4165370A (en) | Injectable gamma globulin | |
| EP1084147B1 (en) | Process for producing immunoglobulins for intravenous administration and other immunoglobulin products | |
| CA1341505C (en) | Intravenously administered polyclonal immunoglobulin preparation containing igm and method of manufacture | |
| US4216205A (en) | Process of preparing a serum protein composition for intravenous application | |
| US20010051708A1 (en) | Process for producing immunoglobulins for intravenous administration and other immunoglobulin products | |
| KR960008653B1 (ko) | γ-글로불린 주사용 액상 제제 | |
| CN115768789A (zh) | 用于获得包含人血浆来源的免疫球蛋白m的组合物的方法 | |
| JPH0768144B2 (ja) | 静脈内投与可能なIgG、IgA及びIgM含有薬物の製造方法 | |
| JPH04346934A (ja) | γ−グロブリンの液状製剤 | |
| JPS6016406B2 (ja) | 静脈内に投与可能なガンマ・グロブリンの製造法ならびにそれにより調製したガンマ・グロブリン | |
| JPH0525862B2 (enExample) | ||
| RU1693751C (ru) | Способ получения иммуноглобулина для внутривенного введения со сниженной антикомплементарной активностью | |
| JP2775097B2 (ja) | 静注用免疫グロブリン製剤 | |
| JP2618643B2 (ja) | 静注用免疫グロブリン製剤 | |
| JPH0375533B2 (enExample) | ||
| JPH0680586A (ja) | 静脈内投与に適したガンマ・グロブリン製剤 |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| A131 | Notification of reasons for refusal |
Free format text: JAPANESE INTERMEDIATE CODE: A131 Effective date: 20070220 |
|
| A601 | Written request for extension of time |
Free format text: JAPANESE INTERMEDIATE CODE: A601 Effective date: 20070517 |
|
| A602 | Written permission of extension of time |
Free format text: JAPANESE INTERMEDIATE CODE: A602 Effective date: 20070522 |
|
| A521 | Request for written amendment filed |
Free format text: JAPANESE INTERMEDIATE CODE: A523 Effective date: 20070820 |
|
| TRDD | Decision of grant or rejection written | ||
| A01 | Written decision to grant a patent or to grant a registration (utility model) |
Free format text: JAPANESE INTERMEDIATE CODE: A01 Effective date: 20071023 |
|
| A61 | First payment of annual fees (during grant procedure) |
Free format text: JAPANESE INTERMEDIATE CODE: A61 Effective date: 20071030 |
|
| R150 | Certificate of patent or registration of utility model |
Free format text: JAPANESE INTERMEDIATE CODE: R150 |
|
| FPAY | Renewal fee payment (event date is renewal date of database) |
Free format text: PAYMENT UNTIL: 20101109 Year of fee payment: 3 |
|
| FPAY | Renewal fee payment (event date is renewal date of database) |
Free format text: PAYMENT UNTIL: 20111109 Year of fee payment: 4 |
|
| FPAY | Renewal fee payment (event date is renewal date of database) |
Free format text: PAYMENT UNTIL: 20121109 Year of fee payment: 5 |
|
| FPAY | Renewal fee payment (event date is renewal date of database) |
Free format text: PAYMENT UNTIL: 20121109 Year of fee payment: 5 |
|
| FPAY | Renewal fee payment (event date is renewal date of database) |
Free format text: PAYMENT UNTIL: 20131109 Year of fee payment: 6 |
|
| R250 | Receipt of annual fees |
Free format text: JAPANESE INTERMEDIATE CODE: R250 |
|
| R250 | Receipt of annual fees |
Free format text: JAPANESE INTERMEDIATE CODE: R250 |
|
| EXPY | Cancellation because of completion of term |