JPH0425255B2 - - Google Patents
Info
- Publication number
- JPH0425255B2 JPH0425255B2 JP58238044A JP23804483A JPH0425255B2 JP H0425255 B2 JPH0425255 B2 JP H0425255B2 JP 58238044 A JP58238044 A JP 58238044A JP 23804483 A JP23804483 A JP 23804483A JP H0425255 B2 JPH0425255 B2 JP H0425255B2
- Authority
- JP
- Japan
- Prior art keywords
- plasma
- silicic acid
- plasma protein
- colloidal silicic
- coagulation
- 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
- 102000004506 Blood Proteins Human genes 0.000 claims abstract description 43
- 108010017384 Blood Proteins Proteins 0.000 claims abstract description 43
- RMAQACBXLXPBSY-UHFFFAOYSA-N silicic acid Chemical compound O[Si](O)(O)O RMAQACBXLXPBSY-UHFFFAOYSA-N 0.000 claims abstract description 40
- 235000012239 silicon dioxide Nutrition 0.000 claims abstract description 40
- 239000012460 protein solution Substances 0.000 claims abstract description 36
- 238000011282 treatment Methods 0.000 claims abstract description 22
- 239000003463 adsorbent Substances 0.000 claims abstract description 10
- 239000002156 adsorbate Substances 0.000 claims abstract description 6
- 238000004519 manufacturing process Methods 0.000 claims abstract description 6
- 239000000203 mixture Substances 0.000 claims abstract description 6
- 230000002439 hemostatic effect Effects 0.000 claims abstract description 4
- 238000001990 intravenous administration Methods 0.000 claims abstract description 4
- 239000000825 pharmaceutical preparation Substances 0.000 claims abstract description 3
- 238000000034 method Methods 0.000 claims description 24
- 238000001179 sorption measurement Methods 0.000 claims description 20
- 210000004369 blood Anatomy 0.000 claims description 17
- 239000008280 blood Substances 0.000 claims description 17
- 230000015271 coagulation Effects 0.000 claims description 15
- 238000005345 coagulation Methods 0.000 claims description 15
- HTTJABKRGRZYRN-UHFFFAOYSA-N Heparin Chemical compound OC1C(NC(=O)C)C(O)OC(COS(O)(=O)=O)C1OC1C(OS(O)(=O)=O)C(O)C(OC2C(C(OS(O)(=O)=O)C(OC3C(C(O)C(O)C(O3)C(O)=O)OS(O)(=O)=O)C(CO)O2)NS(O)(=O)=O)C(C(O)=O)O1 HTTJABKRGRZYRN-UHFFFAOYSA-N 0.000 claims description 10
- 229960002897 heparin Drugs 0.000 claims description 10
- 229920000669 heparin Polymers 0.000 claims description 10
- 238000002360 preparation method Methods 0.000 claims description 9
- 239000012298 atmosphere Substances 0.000 claims description 8
- 239000011261 inert gas Substances 0.000 claims description 7
- 239000003381 stabilizer Substances 0.000 claims description 6
- KRKNYBCHXYNGOX-UHFFFAOYSA-K Citrate Chemical compound [O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O KRKNYBCHXYNGOX-UHFFFAOYSA-K 0.000 claims description 4
- 150000002500 ions Chemical class 0.000 claims description 4
- BHPQYMZQTOCNFJ-UHFFFAOYSA-N Calcium cation Chemical compound [Ca+2] BHPQYMZQTOCNFJ-UHFFFAOYSA-N 0.000 claims description 3
- 229910001424 calcium ion Inorganic materials 0.000 claims description 3
- 238000000605 extraction Methods 0.000 claims description 3
- 230000001678 irradiating effect Effects 0.000 claims description 3
- 238000000926 separation method Methods 0.000 claims description 3
- 230000001954 sterilising effect Effects 0.000 claims description 3
- 238000011146 sterile filtration Methods 0.000 claims description 2
- 238000009472 formulation Methods 0.000 claims 2
- 238000001914 filtration Methods 0.000 claims 1
- 108010049003 Fibrinogen Proteins 0.000 abstract description 21
- 102000008946 Fibrinogen Human genes 0.000 abstract description 21
- 229940012952 fibrinogen Drugs 0.000 abstract description 21
- 239000000243 solution Substances 0.000 abstract description 12
- 239000007858 starting material Substances 0.000 abstract description 3
- 239000000701 coagulant Substances 0.000 abstract 1
- 210000002381 plasma Anatomy 0.000 description 58
- 102000015081 Blood Coagulation Factors Human genes 0.000 description 16
- 108010039209 Blood Coagulation Factors Proteins 0.000 description 16
- 239000003114 blood coagulation factor Substances 0.000 description 16
- 230000000694 effects Effects 0.000 description 15
- 238000009281 ultraviolet germicidal irradiation Methods 0.000 description 12
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 9
- 238000002560 therapeutic procedure Methods 0.000 description 7
- 206010053567 Coagulopathies Diseases 0.000 description 6
- 208000015294 blood coagulation disease Diseases 0.000 description 6
- 239000012503 blood component Substances 0.000 description 6
- 208000006454 hepatitis Diseases 0.000 description 6
- 231100000283 hepatitis Toxicity 0.000 description 6
- 102000004169 proteins and genes Human genes 0.000 description 6
- 108090000623 proteins and genes Proteins 0.000 description 6
- VEZXCJBBBCKRPI-UHFFFAOYSA-N beta-propiolactone Chemical compound O=C1CCO1 VEZXCJBBBCKRPI-UHFFFAOYSA-N 0.000 description 5
- 230000023555 blood coagulation Effects 0.000 description 5
- 208000035475 disorder Diseases 0.000 description 5
- 229960000380 propiolactone Drugs 0.000 description 5
- 238000005119 centrifugation Methods 0.000 description 4
- 201000010099 disease Diseases 0.000 description 4
- 208000031169 hemorrhagic disease Diseases 0.000 description 4
- 210000000056 organ Anatomy 0.000 description 4
- 238000012360 testing method Methods 0.000 description 4
- IJGRMHOSHXDMSA-UHFFFAOYSA-N Atomic nitrogen Chemical compound N#N IJGRMHOSHXDMSA-UHFFFAOYSA-N 0.000 description 3
- 102000009123 Fibrin Human genes 0.000 description 3
- 108010073385 Fibrin Proteins 0.000 description 3
- BWGVNKXGVNDBDI-UHFFFAOYSA-N Fibrin monomer Chemical compound CNC(=O)CNC(=O)CN BWGVNKXGVNDBDI-UHFFFAOYSA-N 0.000 description 3
- 229950003499 fibrin Drugs 0.000 description 3
- 238000004108 freeze drying Methods 0.000 description 3
- 238000001802 infusion Methods 0.000 description 3
- 239000001509 sodium citrate Substances 0.000 description 3
- NLJMYIDDQXHKNR-UHFFFAOYSA-K sodium citrate Chemical compound O.O.[Na+].[Na+].[Na+].[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O NLJMYIDDQXHKNR-UHFFFAOYSA-K 0.000 description 3
- 208000024891 symptom Diseases 0.000 description 3
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 3
- XKRFYHLGVUSROY-UHFFFAOYSA-N Argon Chemical compound [Ar] XKRFYHLGVUSROY-UHFFFAOYSA-N 0.000 description 2
- 206010062713 Haemorrhagic diathesis Diseases 0.000 description 2
- 108090000113 Plasma Kallikrein Proteins 0.000 description 2
- 239000004019 antithrombin Substances 0.000 description 2
- 239000010836 blood and blood product Substances 0.000 description 2
- 229940125691 blood product Drugs 0.000 description 2
- 238000006243 chemical reaction Methods 0.000 description 2
- 230000035602 clotting Effects 0.000 description 2
- 230000009852 coagulant defect Effects 0.000 description 2
- 239000012141 concentrate Substances 0.000 description 2
- 208000009190 disseminated intravascular coagulation Diseases 0.000 description 2
- 210000003743 erythrocyte Anatomy 0.000 description 2
- 239000004023 fresh frozen plasma Substances 0.000 description 2
- 239000007789 gas Substances 0.000 description 2
- 230000023597 hemostasis Effects 0.000 description 2
- 239000012931 lyophilized formulation Substances 0.000 description 2
- 238000012423 maintenance Methods 0.000 description 2
- 230000017074 necrotic cell death Effects 0.000 description 2
- 239000012299 nitrogen atmosphere Substances 0.000 description 2
- 238000011176 pooling Methods 0.000 description 2
- 239000000047 product Substances 0.000 description 2
- 210000002966 serum Anatomy 0.000 description 2
- 238000004659 sterilization and disinfection Methods 0.000 description 2
- 230000009885 systemic effect Effects 0.000 description 2
- 208000010444 Acidosis Diseases 0.000 description 1
- 229910002019 Aerosil® 380 Inorganic materials 0.000 description 1
- 102000009027 Albumins Human genes 0.000 description 1
- 108010088751 Albumins Proteins 0.000 description 1
- 241000282461 Canis lupus Species 0.000 description 1
- 108010080865 Factor XII Proteins 0.000 description 1
- 102000000429 Factor XII Human genes 0.000 description 1
- 108010071241 Factor XIIa Proteins 0.000 description 1
- 102000006395 Globulins Human genes 0.000 description 1
- 108010044091 Globulins Proteins 0.000 description 1
- 208000032843 Hemorrhage Diseases 0.000 description 1
- 208000032456 Hemorrhagic Shock Diseases 0.000 description 1
- 208000024659 Hemostatic disease Diseases 0.000 description 1
- 102000008100 Human Serum Albumin Human genes 0.000 description 1
- 108091006905 Human Serum Albumin Proteins 0.000 description 1
- 208000001953 Hypotension Diseases 0.000 description 1
- 206010021143 Hypoxia Diseases 0.000 description 1
- 108060003951 Immunoglobulin Proteins 0.000 description 1
- 206010028980 Neoplasm Diseases 0.000 description 1
- 208000035965 Postoperative Complications Diseases 0.000 description 1
- 101100219985 Rattus norvegicus Ccn3 gene Proteins 0.000 description 1
- 206010049771 Shock haemorrhagic Diseases 0.000 description 1
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 description 1
- 208000007536 Thrombosis Diseases 0.000 description 1
- 241000700605 Viruses Species 0.000 description 1
- 230000007950 acidosis Effects 0.000 description 1
- 208000026545 acidosis disease Diseases 0.000 description 1
- 239000012190 activator Substances 0.000 description 1
- 230000006978 adaptation Effects 0.000 description 1
- 210000004381 amniotic fluid Anatomy 0.000 description 1
- 230000002052 anaphylactic effect Effects 0.000 description 1
- 230000000603 anti-haemophilic effect Effects 0.000 description 1
- 239000003146 anticoagulant agent Substances 0.000 description 1
- 229910052786 argon Inorganic materials 0.000 description 1
- 230000001580 bacterial effect Effects 0.000 description 1
- 230000005540 biological transmission Effects 0.000 description 1
- 230000015572 biosynthetic process Effects 0.000 description 1
- 208000034158 bleeding Diseases 0.000 description 1
- 230000000740 bleeding effect Effects 0.000 description 1
- 239000003686 blood clotting factor concentrate Substances 0.000 description 1
- 201000011510 cancer Diseases 0.000 description 1
- 230000006866 deterioration Effects 0.000 description 1
- 238000002405 diagnostic procedure Methods 0.000 description 1
- 229910001873 dinitrogen Inorganic materials 0.000 description 1
- 239000012153 distilled water Substances 0.000 description 1
- 230000010102 embolization Effects 0.000 description 1
- 238000005516 engineering process Methods 0.000 description 1
- 239000012634 fragment Substances 0.000 description 1
- 238000007710 freezing Methods 0.000 description 1
- 230000008014 freezing Effects 0.000 description 1
- 102000018358 immunoglobulin Human genes 0.000 description 1
- 229940072221 immunoglobulins Drugs 0.000 description 1
- 230000001771 impaired effect Effects 0.000 description 1
- 230000002779 inactivation Effects 0.000 description 1
- 208000015181 infectious disease Diseases 0.000 description 1
- 239000003112 inhibitor Substances 0.000 description 1
- 230000002401 inhibitory effect Effects 0.000 description 1
- 230000000977 initiatory effect Effects 0.000 description 1
- 208000014674 injury Diseases 0.000 description 1
- 239000013067 intermediate product Substances 0.000 description 1
- 238000005342 ion exchange Methods 0.000 description 1
- 229910052743 krypton Inorganic materials 0.000 description 1
- DNNSSWSSYDEUBZ-UHFFFAOYSA-N krypton atom Chemical compound [Kr] DNNSSWSSYDEUBZ-UHFFFAOYSA-N 0.000 description 1
- 230000003902 lesion Effects 0.000 description 1
- 208000032839 leukemia Diseases 0.000 description 1
- -1 lyophilized plasma Substances 0.000 description 1
- 230000007246 mechanism Effects 0.000 description 1
- 230000001404 mediated effect Effects 0.000 description 1
- 239000012528 membrane Substances 0.000 description 1
- 230000004060 metabolic process Effects 0.000 description 1
- 230000004089 microcirculation Effects 0.000 description 1
- 229910052757 nitrogen Inorganic materials 0.000 description 1
- 230000001575 pathological effect Effects 0.000 description 1
- 230000010412 perfusion Effects 0.000 description 1
- 239000002504 physiological saline solution Substances 0.000 description 1
- 238000001556 precipitation Methods 0.000 description 1
- 238000012545 processing Methods 0.000 description 1
- 230000001681 protective effect Effects 0.000 description 1
- 108010012557 prothrombin complex concentrates Proteins 0.000 description 1
- 238000003908 quality control method Methods 0.000 description 1
- 230000005855 radiation Effects 0.000 description 1
- 238000011160 research Methods 0.000 description 1
- 230000006641 stabilisation Effects 0.000 description 1
- 238000011105 stabilization Methods 0.000 description 1
- 238000003756 stirring Methods 0.000 description 1
- 238000003860 storage Methods 0.000 description 1
- 239000003634 thrombocyte concentrate Substances 0.000 description 1
- 230000008733 trauma Effects 0.000 description 1
- 238000000108 ultra-filtration Methods 0.000 description 1
- 230000003612 virological effect Effects 0.000 description 1
Classifications
-
- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
- C12N9/00—Enzymes; Proenzymes; Compositions thereof; Processes for preparing, activating, inhibiting, separating or purifying enzymes
- C12N9/14—Hydrolases (3)
- C12N9/48—Hydrolases (3) acting on peptide bonds (3.4)
- C12N9/50—Proteinases, e.g. Endopeptidases (3.4.21-3.4.25)
- C12N9/64—Proteinases, e.g. Endopeptidases (3.4.21-3.4.25) derived from animal tissue
- C12N9/6421—Proteinases, e.g. Endopeptidases (3.4.21-3.4.25) derived from animal tissue from mammals
- C12N9/6424—Serine endopeptidases (3.4.21)
- C12N9/647—Blood coagulation factors not provided for in a preceding group or according to more than one of the proceeding groups
-
- 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
- C07K14/745—Blood coagulation or fibrinolysis factors
-
- 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
- C07K14/745—Blood coagulation or fibrinolysis factors
- C07K14/755—Factors VIII, e.g. factor VIII C (AHF), factor VIII Ag (VWF)
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- C07K14/81—Protease inhibitors
- C07K14/8107—Endopeptidase (E.C. 3.4.21-99) inhibitors
- C07K14/811—Serine protease (E.C. 3.4.21) inhibitors
- C07K14/8121—Serpins
- C07K14/8128—Antithrombin III
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- Life Sciences & Earth Sciences (AREA)
- Genetics & Genomics (AREA)
- Molecular Biology (AREA)
- Zoology (AREA)
- Biochemistry (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Hematology (AREA)
- Engineering & Computer Science (AREA)
- Biophysics (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Gastroenterology & Hepatology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Biomedical Technology (AREA)
- Toxicology (AREA)
- Wood Science & Technology (AREA)
- Biotechnology (AREA)
- Microbiology (AREA)
- General Engineering & Computer Science (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
- Peptides Or Proteins (AREA)
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| DE19823247150 DE3247150A1 (de) | 1982-12-21 | 1982-12-21 | Gerinnungsaktive plasmaproteinloesung, verfahren zu ihrer herstellung und ihre verwendung zur behandlung von stoerungen des haemostasesystems |
| DE3247150.5 | 1982-12-21 |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| JPS59118710A JPS59118710A (ja) | 1984-07-09 |
| JPH0425255B2 true JPH0425255B2 (US06811534-20041102-M00003.png) | 1992-04-30 |
Family
ID=6181202
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP58238044A Granted JPS59118710A (ja) | 1982-12-21 | 1983-12-19 | 凝固活性血漿蛋白溶液、その製造方法並びに製剤 |
Country Status (5)
Families Citing this family (15)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP0212040B1 (de) * | 1985-08-05 | 1990-05-23 | IMMUNO Aktiengesellschaft für chemisch-medizinische Produkte | Verfahren zur Herstellung von Präparationen auf Basis von Blutgerinnungsfaktoren |
| JPS6317899A (ja) * | 1986-07-09 | 1988-01-25 | Green Cross Corp:The | ハプトグロビンの精製方法 |
| US4725673A (en) * | 1986-08-29 | 1988-02-16 | Alpha Therapeutic Corporation | Plasma fraction purification using silica resin bound to a ligand |
| JPH0219400A (ja) * | 1988-07-07 | 1990-01-23 | Green Cross Corp:The | トロンビンまたはプロトロンビンの製造方法 |
| US7211380B1 (en) * | 1989-03-01 | 2007-05-01 | Shionogi & Co., Ltd. | Physiologically active polypeptide and DNA |
| US6187572B1 (en) | 1990-04-16 | 2001-02-13 | Baxter International Inc. | Method of inactivation of viral and bacterial blood contaminants |
| US5418130A (en) * | 1990-04-16 | 1995-05-23 | Cryopharm Corporation | Method of inactivation of viral and bacterial blood contaminants |
| US5520885A (en) * | 1993-01-19 | 1996-05-28 | Thermogenesis Corporation | Fibrinogen processing apparatus, method and container |
| US20030040480A1 (en) * | 2001-07-20 | 2003-02-27 | Rasmus Rojkjaer | Pharmaceutical composition comprising factor VII polypeptides and factor XI polypeptides |
| CA2460023A1 (en) * | 2001-09-10 | 2003-03-20 | Zymogenetics, Inc. | Method for treating coumarin-induced hemorrhage |
| EP1935429A1 (en) | 2006-12-22 | 2008-06-25 | CSL Behring GmbH | Synergistic therapeutic use of prothrombin complex concentrates with FVIII concentrates |
| WO2011150284A2 (en) | 2010-05-26 | 2011-12-01 | Baxter International Inc. | Removal of serine proteases by treatment with finely divided silicon dioxide |
| AU2010202125B1 (en) | 2010-05-26 | 2010-09-02 | Takeda Pharmaceutical Company Limited | A method to produce an immunoglobulin preparation with improved yield |
| EP3694322B1 (en) | 2017-10-09 | 2024-07-03 | Terumo BCT Biotechnologies, LLC | Lyophilization container and method of using same |
| WO2020185916A1 (en) | 2019-03-14 | 2020-09-17 | Terumo Bct Biotechnologies, Llc | Lyophilization container fill fixture, system and method of use |
Family Cites Families (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| NL6702923A (US06811534-20041102-M00003.png) * | 1966-04-06 | 1967-10-09 | ||
| DE2459291C3 (de) * | 1974-12-14 | 1981-06-04 | Biotest-Serum-Institut Gmbh, 6000 Frankfurt | Verfahren zur Herstellung eines antihämophiles Globulin A enthaltenden Konzentrats neben einem Prothrombin- Komplex und einer Lösung von lagerstabilen Serumproteinen |
| US3998946A (en) * | 1975-04-23 | 1976-12-21 | The Regents Of The University Of Minnesota | Fibrinogen-free plasminogen-plasmin-free plasma and method of preparing and using same |
| DE2902158A1 (de) * | 1979-01-20 | 1980-07-31 | Biotest Serum Institut Gmbh | Verfahren zur herstellung von fibrinogen, einem die gerinnungsfaktoren ii, vii, ix und x enthaltenden prothrombinkomplex, antithrombin iii und einer loesung von lagerstabilen serumproteinen |
-
1982
- 1982-12-21 DE DE19823247150 patent/DE3247150A1/de not_active Withdrawn
-
1983
- 1983-11-25 AT AT83111816T patent/ATE25690T1/de active
- 1983-11-25 EP EP83111816A patent/EP0111777B1/de not_active Expired
- 1983-11-25 DE DE8383111816T patent/DE3369998D1/de not_active Expired
- 1983-12-14 US US06/561,390 patent/US4503039A/en not_active Expired - Fee Related
- 1983-12-19 JP JP58238044A patent/JPS59118710A/ja active Granted
Also Published As
| Publication number | Publication date |
|---|---|
| DE3247150A1 (de) | 1984-06-28 |
| DE3369998D1 (en) | 1987-04-09 |
| EP0111777A1 (de) | 1984-06-27 |
| EP0111777B1 (de) | 1987-03-04 |
| JPS59118710A (ja) | 1984-07-09 |
| ATE25690T1 (de) | 1987-03-15 |
| US4503039A (en) | 1985-03-05 |
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