CA1054052A - Simplified method for preparation of high yield, high purity factor viii concentrate - Google Patents
Simplified method for preparation of high yield, high purity factor viii concentrateInfo
- Publication number
- CA1054052A CA1054052A CA258,324A CA258324A CA1054052A CA 1054052 A CA1054052 A CA 1054052A CA 258324 A CA258324 A CA 258324A CA 1054052 A CA1054052 A CA 1054052A
- Authority
- CA
- Canada
- Prior art keywords
- factor viii
- fibrinogen
- cryoprecipitate
- percent
- concentrate
- 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
Links
- 238000000034 method Methods 0.000 title claims abstract description 37
- 229960000301 factor viii Drugs 0.000 title claims abstract description 34
- 239000012141 concentrate Substances 0.000 title claims abstract description 14
- 238000002360 preparation method Methods 0.000 title abstract description 5
- 108010054218 Factor VIII Proteins 0.000 claims abstract description 32
- 102000001690 Factor VIII Human genes 0.000 claims abstract description 32
- 229940012952 fibrinogen Drugs 0.000 claims description 23
- 108010049003 Fibrinogen Proteins 0.000 claims description 22
- 102000008946 Fibrinogen Human genes 0.000 claims description 22
- 239000007788 liquid Substances 0.000 claims description 16
- 238000001816 cooling Methods 0.000 claims description 11
- 239000000047 product Substances 0.000 claims description 10
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 9
- 239000006228 supernatant Substances 0.000 claims description 7
- 239000007858 starting material Substances 0.000 claims description 6
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims description 5
- 102000004169 proteins and genes Human genes 0.000 claims description 5
- 108090000623 proteins and genes Proteins 0.000 claims description 5
- 239000011780 sodium chloride Substances 0.000 claims description 5
- 239000012153 distilled water Substances 0.000 claims description 4
- 230000001376 precipitating effect Effects 0.000 claims description 4
- 238000003860 storage Methods 0.000 claims description 4
- 150000002632 lipids Chemical class 0.000 claims description 3
- 229920005862 polyol Polymers 0.000 claims description 3
- 150000003077 polyols Chemical class 0.000 claims description 3
- 238000001179 sorption measurement Methods 0.000 claims description 3
- 239000012736 aqueous medium Substances 0.000 claims description 2
- 238000004090 dissolution Methods 0.000 claims description 2
- 230000007774 longterm Effects 0.000 claims description 2
- 230000000087 stabilizing effect Effects 0.000 claims description 2
- 230000001954 sterilising effect Effects 0.000 claims description 2
- 239000000203 mixture Substances 0.000 claims 1
- 238000001556 precipitation Methods 0.000 abstract description 13
- 101000911390 Homo sapiens Coagulation factor VIII Proteins 0.000 description 21
- 102100026735 Coagulation factor VIII Human genes 0.000 description 20
- DHMQDGOQFOQNFH-UHFFFAOYSA-N Glycine Chemical compound NCC(O)=O DHMQDGOQFOQNFH-UHFFFAOYSA-N 0.000 description 8
- 238000000605 extraction Methods 0.000 description 7
- 239000000243 solution Substances 0.000 description 7
- 238000004519 manufacturing process Methods 0.000 description 6
- 239000000126 substance Substances 0.000 description 6
- 229920001223 polyethylene glycol Polymers 0.000 description 5
- 239000004471 Glycine Substances 0.000 description 4
- 208000006454 hepatitis Diseases 0.000 description 4
- 231100000283 hepatitis Toxicity 0.000 description 4
- 238000000746 purification Methods 0.000 description 4
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 description 3
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 description 3
- 239000012467 final product Substances 0.000 description 3
- 150000002500 ions Chemical class 0.000 description 3
- 239000002244 precipitate Substances 0.000 description 3
- 239000002202 Polyethylene glycol Substances 0.000 description 2
- 239000007983 Tris buffer Substances 0.000 description 2
- 241000700605 Viruses Species 0.000 description 2
- WNROFYMDJYEPJX-UHFFFAOYSA-K aluminium hydroxide Chemical compound [OH-].[OH-].[OH-].[Al+3] WNROFYMDJYEPJX-UHFFFAOYSA-K 0.000 description 2
- 229940024545 aluminum hydroxide Drugs 0.000 description 2
- 230000000603 anti-haemophilic effect Effects 0.000 description 2
- 239000000427 antigen Substances 0.000 description 2
- 102000036639 antigens Human genes 0.000 description 2
- 108091007433 antigens Proteins 0.000 description 2
- 239000000872 buffer Substances 0.000 description 2
- 238000005119 centrifugation Methods 0.000 description 2
- 238000011109 contamination Methods 0.000 description 2
- 230000007423 decrease Effects 0.000 description 2
- 230000000694 effects Effects 0.000 description 2
- 239000000463 material Substances 0.000 description 2
- 229920001983 poloxamer Polymers 0.000 description 2
- 230000001698 pyrogenic effect Effects 0.000 description 2
- 238000011084 recovery Methods 0.000 description 2
- 239000002002 slurry Substances 0.000 description 2
- LENZDBCJOHFCAS-UHFFFAOYSA-N tris Chemical compound OCC(N)(CO)CO LENZDBCJOHFCAS-UHFFFAOYSA-N 0.000 description 2
- TUSDEZXZIZRFGC-UHFFFAOYSA-N 1-O-galloyl-3,6-(R)-HHDP-beta-D-glucose Natural products OC1C(O2)COC(=O)C3=CC(O)=C(O)C(O)=C3C3=C(O)C(O)=C(O)C=C3C(=O)OC1C(O)C2OC(=O)C1=CC(O)=C(O)C(O)=C1 TUSDEZXZIZRFGC-UHFFFAOYSA-N 0.000 description 1
- 102000009027 Albumins Human genes 0.000 description 1
- 108010088751 Albumins Proteins 0.000 description 1
- 241000370685 Arge Species 0.000 description 1
- 102000004506 Blood Proteins Human genes 0.000 description 1
- 108010017384 Blood Proteins Proteins 0.000 description 1
- 108010035369 Cohn fraction I Proteins 0.000 description 1
- 239000001263 FEMA 3042 Substances 0.000 description 1
- 208000031220 Hemophilia Diseases 0.000 description 1
- 208000009292 Hemophilia A Diseases 0.000 description 1
- 102000018721 Macroglobulins Human genes 0.000 description 1
- 108010091934 Macroglobulins Proteins 0.000 description 1
- LRBQNJMCXXYXIU-PPKXGCFTSA-N Penta-digallate-beta-D-glucose Natural products OC1=C(O)C(O)=CC(C(=O)OC=2C(=C(O)C=C(C=2)C(=O)OC[C@@H]2[C@H]([C@H](OC(=O)C=3C=C(OC(=O)C=4C=C(O)C(O)=C(O)C=4)C(O)=C(O)C=3)[C@@H](OC(=O)C=3C=C(OC(=O)C=4C=C(O)C(O)=C(O)C=4)C(O)=C(O)C=3)[C@H](OC(=O)C=3C=C(OC(=O)C=4C=C(O)C(O)=C(O)C=4)C(O)=C(O)C=3)O2)OC(=O)C=2C=C(OC(=O)C=3C=C(O)C(O)=C(O)C=3)C(O)=C(O)C=2)O)=C1 LRBQNJMCXXYXIU-PPKXGCFTSA-N 0.000 description 1
- 108010094028 Prothrombin Proteins 0.000 description 1
- 102100027378 Prothrombin Human genes 0.000 description 1
- 238000010521 absorption reaction Methods 0.000 description 1
- 238000007792 addition Methods 0.000 description 1
- 238000004220 aggregation Methods 0.000 description 1
- 230000002776 aggregation Effects 0.000 description 1
- 229940024546 aluminum hydroxide gel Drugs 0.000 description 1
- SMYKVLBUSSNXMV-UHFFFAOYSA-K aluminum;trihydroxide;hydrate Chemical compound O.[OH-].[OH-].[OH-].[Al+3] SMYKVLBUSSNXMV-UHFFFAOYSA-K 0.000 description 1
- BFNBIHQBYMNNAN-UHFFFAOYSA-N ammonium sulfate Chemical compound N.N.OS(O)(=O)=O BFNBIHQBYMNNAN-UHFFFAOYSA-N 0.000 description 1
- 229910052921 ammonium sulfate Inorganic materials 0.000 description 1
- 235000011130 ammonium sulphate Nutrition 0.000 description 1
- 230000001580 bacterial effect Effects 0.000 description 1
- 229920001400 block copolymer Polymers 0.000 description 1
- 239000008280 blood Substances 0.000 description 1
- 210000004369 blood Anatomy 0.000 description 1
- 230000036765 blood level Effects 0.000 description 1
- 239000001506 calcium phosphate Substances 0.000 description 1
- 238000012512 characterization method Methods 0.000 description 1
- 238000006243 chemical reaction Methods 0.000 description 1
- 238000004587 chromatography analysis Methods 0.000 description 1
- 239000000356 contaminant Substances 0.000 description 1
- 230000002844 continuous effect Effects 0.000 description 1
- 230000003247 decreasing effect Effects 0.000 description 1
- 239000007857 degradation product Substances 0.000 description 1
- 230000001419 dependent effect Effects 0.000 description 1
- 230000008030 elimination Effects 0.000 description 1
- 238000003379 elimination reaction Methods 0.000 description 1
- 238000010828 elution Methods 0.000 description 1
- 239000000839 emulsion Substances 0.000 description 1
- 235000019441 ethanol Nutrition 0.000 description 1
- 238000001914 filtration Methods 0.000 description 1
- 239000012530 fluid Substances 0.000 description 1
- 238000005187 foaming Methods 0.000 description 1
- 238000005194 fractionation Methods 0.000 description 1
- 238000007710 freezing Methods 0.000 description 1
- 230000008014 freezing Effects 0.000 description 1
- 108010074605 gamma-Globulins Proteins 0.000 description 1
- 229960002897 heparin Drugs 0.000 description 1
- 229920000669 heparin Polymers 0.000 description 1
- 102000057593 human F8 Human genes 0.000 description 1
- 229960000900 human factor viii Drugs 0.000 description 1
- 238000002955 isolation Methods 0.000 description 1
- 238000011031 large-scale manufacturing process Methods 0.000 description 1
- 239000012528 membrane Substances 0.000 description 1
- -1 poly(oxyethylene) Polymers 0.000 description 1
- 239000011148 porous material Substances 0.000 description 1
- 230000003389 potentiating effect Effects 0.000 description 1
- 230000002035 prolonged effect Effects 0.000 description 1
- 229940039716 prothrombin Drugs 0.000 description 1
- 239000001509 sodium citrate 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
- LRBQNJMCXXYXIU-NRMVVENXSA-N tannic acid Chemical compound OC1=C(O)C(O)=CC(C(=O)OC=2C(=C(O)C=C(C=2)C(=O)OC[C@@H]2[C@H]([C@H](OC(=O)C=3C=C(OC(=O)C=4C=C(O)C(O)=C(O)C=4)C(O)=C(O)C=3)[C@@H](OC(=O)C=3C=C(OC(=O)C=4C=C(O)C(O)=C(O)C=4)C(O)=C(O)C=3)[C@@H](OC(=O)C=3C=C(OC(=O)C=4C=C(O)C(O)=C(O)C=4)C(O)=C(O)C=3)O2)OC(=O)C=2C=C(OC(=O)C=3C=C(O)C(O)=C(O)C=3)C(O)=C(O)C=2)O)=C1 LRBQNJMCXXYXIU-NRMVVENXSA-N 0.000 description 1
- 229940033123 tannic acid Drugs 0.000 description 1
- 235000015523 tannic acid Nutrition 0.000 description 1
- 229920002258 tannic acid Polymers 0.000 description 1
- 238000010257 thawing Methods 0.000 description 1
- 230000001225 therapeutic effect Effects 0.000 description 1
- QORWJWZARLRLPR-UHFFFAOYSA-H tricalcium bis(phosphate) Chemical compound [Ca+2].[Ca+2].[Ca+2].[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O QORWJWZARLRLPR-UHFFFAOYSA-H 0.000 description 1
- 229940078499 tricalcium phosphate Drugs 0.000 description 1
- 229910000391 tricalcium phosphate Inorganic materials 0.000 description 1
- 235000019731 tricalcium phosphate Nutrition 0.000 description 1
- HRXKRNGNAMMEHJ-UHFFFAOYSA-K trisodium citrate Chemical compound [Na+].[Na+].[Na+].[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O HRXKRNGNAMMEHJ-UHFFFAOYSA-K 0.000 description 1
- 229940038773 trisodium citrate Drugs 0.000 description 1
- 238000010792 warming Methods 0.000 description 1
Classifications
-
- 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)
-
- 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)
- Biophysics (AREA)
- Medicinal Chemistry (AREA)
- Zoology (AREA)
- Biochemistry (AREA)
- Toxicology (AREA)
- General Health & Medical Sciences (AREA)
- Genetics & Genomics (AREA)
- Gastroenterology & Hepatology (AREA)
- Molecular Biology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Hematology (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 (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| DE19762636757 DE2636757C2 (de) | 1976-08-14 | 1976-08-14 | Verfahren zum Aufkonzentrieren und Reinigen des Antihämophiliefaktors |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA1054052A true CA1054052A (en) | 1979-05-08 |
Family
ID=5985522
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA258,324A Expired CA1054052A (en) | 1976-08-14 | 1976-08-03 | Simplified method for preparation of high yield, high purity factor viii concentrate |
Country Status (7)
| Country | Link |
|---|---|
| JP (1) | JPS5910645B2 (de) |
| AT (1) | AT349639B (de) |
| CA (1) | CA1054052A (de) |
| DE (1) | DE2636757C2 (de) |
| GB (1) | GB1551928A (de) |
| NL (1) | NL177181C (de) |
| SE (1) | SE448274B (de) |
Families Citing this family (14)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4302445A (en) * | 1980-01-18 | 1981-11-24 | Institut Merieux | Method for concentrating and purifying antihemophilic factor or factor VIII |
| AT369263B (de) | 1980-08-27 | 1982-12-27 | Immuno Ag | Verfahren zur herstellung eines faktor viii(ahf) -hochkonzentrates |
| JPS5867627A (ja) * | 1981-10-12 | 1983-04-22 | ア−マ−・フア−マシユ−テイカル・カンパニ− | 高純度抗血友病性因子の製造法 |
| DE3318521A1 (de) * | 1983-05-20 | 1984-11-22 | Lentia GmbH Chem. u. pharm. Erzeugnisse - Industriebedarf, 8000 München | Verfahren zur herstellung eines antihaemophiliefaktor-konzentrats |
| AT379510B (de) * | 1983-05-20 | 1986-01-27 | Immuno Ag | Verfahren zur herstellung einer faktor viii (ahf) -haeltigen praeparation |
| AU6487286A (en) * | 1985-11-08 | 1987-05-14 | Baxter Travenol Laboratories Inc. | Antihemophilic factor by cold precipitation |
| ATE73820T1 (de) * | 1986-03-27 | 1992-04-15 | Octapharma Ag | Verfahren zur herstellung eines hochgereinigten antihaemophilie-faktors. |
| AT391808B (de) * | 1986-11-03 | 1990-12-10 | Immuno Ag | Verfahren zur herstellung einer faktor viii (ahf)-haeltigen fraktion |
| DE3926034C3 (de) * | 1989-08-07 | 1996-11-21 | Behringwerke Ag | Verfahren zur Herstellung eines stabilen Faktors VIII |
| DE69826531T2 (de) * | 1998-06-23 | 2005-09-22 | Shanbrom Technologies, LLC, Ojai | Verfahren und vorrichtung zur herstellung von gereinigten plasmaproteinen |
| WO2000061776A1 (en) * | 1999-04-14 | 2000-10-19 | Mercian Corporation | Vitamin d derivatives and process for producing the same |
| DE102004009400A1 (de) | 2004-02-24 | 2005-09-08 | Zlb Behring Gmbh | Fibrinogen Reinigung |
| JP7110360B2 (ja) | 2017-10-09 | 2022-08-01 | テルモ ビーシーティー バイオテクノロジーズ,エルエルシー | 凍結乾燥方法 |
| CN113614477B (zh) | 2019-03-14 | 2023-04-28 | 泰尔茂比司特生物技术有限公司 | 冷冻干燥装载托盘组件及系统 |
Family Cites Families (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US2543808A (en) * | 1946-12-26 | 1951-03-06 | Parke Davis & Co | Method of preparing fibrinogen |
| GB1507198A (en) * | 1974-04-12 | 1978-04-12 | Squibb & Sons Inc | Antihemophilic factor |
-
1976
- 1976-08-03 CA CA258,324A patent/CA1054052A/en not_active Expired
- 1976-08-05 GB GB3258876A patent/GB1551928A/en not_active Expired
- 1976-08-12 SE SE7609012A patent/SE448274B/xx unknown
- 1976-08-14 DE DE19762636757 patent/DE2636757C2/de not_active Expired
- 1976-08-17 AT AT611376A patent/AT349639B/de not_active IP Right Cessation
- 1976-08-23 JP JP51099638A patent/JPS5910645B2/ja not_active Expired
- 1976-08-23 NL NL7609349A patent/NL177181C/xx not_active IP Right Cessation
Also Published As
| Publication number | Publication date |
|---|---|
| JPS5326313A (en) | 1978-03-11 |
| SE7609012L (sv) | 1978-02-13 |
| DE2636757C2 (de) | 1984-07-05 |
| ATA611376A (de) | 1978-09-15 |
| DE2636757A1 (de) | 1978-02-16 |
| AT349639B (de) | 1979-04-10 |
| JPS5910645B2 (ja) | 1984-03-10 |
| NL177181B (nl) | 1985-03-18 |
| NL177181C (nl) | 1985-08-16 |
| GB1551928A (en) | 1979-09-05 |
| SE448274B (sv) | 1987-02-09 |
| NL7609349A (nl) | 1978-02-27 |
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