DE3430320A1 - Verfahren zur herstellung von immunglobulin-praeparaten mit verminderter komplementaktivitaet - Google Patents
Verfahren zur herstellung von immunglobulin-praeparaten mit verminderter komplementaktivitaetInfo
- Publication number
- DE3430320A1 DE3430320A1 DE19843430320 DE3430320A DE3430320A1 DE 3430320 A1 DE3430320 A1 DE 3430320A1 DE 19843430320 DE19843430320 DE 19843430320 DE 3430320 A DE3430320 A DE 3430320A DE 3430320 A1 DE3430320 A1 DE 3430320A1
- Authority
- DE
- Germany
- Prior art keywords
- immunoglobulin
- solution
- concentration
- polyethylene glycol
- peg
- 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.)
- Withdrawn
Links
- 108060003951 Immunoglobulin Proteins 0.000 title claims abstract description 59
- 102000018358 immunoglobulin Human genes 0.000 title claims abstract description 59
- 238000002360 preparation method Methods 0.000 title claims description 22
- 238000000034 method Methods 0.000 title claims description 19
- 230000024203 complement activation Effects 0.000 title claims description 9
- 230000002829 reductive effect Effects 0.000 title claims description 7
- 229920001223 polyethylene glycol Polymers 0.000 claims abstract description 26
- 239000002202 Polyethylene glycol Substances 0.000 claims abstract description 25
- DHMQDGOQFOQNFH-UHFFFAOYSA-N Glycine Chemical compound NCC(O)=O DHMQDGOQFOQNFH-UHFFFAOYSA-N 0.000 claims abstract description 16
- 239000002244 precipitate Substances 0.000 claims abstract description 14
- 102000004169 proteins and genes Human genes 0.000 claims abstract description 12
- 108090000623 proteins and genes Proteins 0.000 claims abstract description 12
- 229960002449 glycine Drugs 0.000 claims abstract description 8
- 235000013905 glycine and its sodium salt Nutrition 0.000 claims abstract description 8
- 239000006228 supernatant Substances 0.000 claims abstract description 6
- 229940057838 polyethylene glycol 4000 Drugs 0.000 claims abstract description 5
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims description 16
- 238000001556 precipitation Methods 0.000 claims description 10
- 150000001768 cations Chemical class 0.000 claims description 6
- 150000001450 anions Chemical class 0.000 claims description 5
- 238000004519 manufacturing process Methods 0.000 claims description 5
- 239000002904 solvent Substances 0.000 claims description 5
- 150000003839 salts Chemical class 0.000 claims description 4
- 238000000926 separation method Methods 0.000 claims description 3
- 230000003171 anti-complementary effect Effects 0.000 abstract description 19
- 229940072221 immunoglobulins Drugs 0.000 abstract description 10
- 108010032597 Cohn fraction II Proteins 0.000 abstract description 6
- 239000000243 solution Substances 0.000 description 58
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 description 31
- 239000011780 sodium chloride Substances 0.000 description 13
- 108010074605 gamma-Globulins Proteins 0.000 description 7
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 description 6
- 238000001990 intravenous administration Methods 0.000 description 6
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 description 5
- 229920001030 Polyethylene Glycol 4000 Polymers 0.000 description 5
- 229920005654 Sephadex Polymers 0.000 description 5
- 239000012507 Sephadex™ Substances 0.000 description 5
- 239000008103 glucose Substances 0.000 description 5
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 description 4
- 230000000295 complement effect Effects 0.000 description 4
- OKTJSMMVPCPJKN-UHFFFAOYSA-N Carbon Chemical compound [C] OKTJSMMVPCPJKN-UHFFFAOYSA-N 0.000 description 2
- 229920001612 Hydroxyethyl starch Polymers 0.000 description 2
- 229920002684 Sepharose Polymers 0.000 description 2
- 239000007864 aqueous solution Substances 0.000 description 2
- 238000005194 fractionation Methods 0.000 description 2
- 229940050526 hydroxyethylstarch Drugs 0.000 description 2
- 239000012535 impurity Substances 0.000 description 2
- 239000000463 material Substances 0.000 description 2
- 239000000203 mixture Substances 0.000 description 2
- 239000008363 phosphate buffer Substances 0.000 description 2
- 239000013049 sediment Substances 0.000 description 2
- 238000007086 side reaction Methods 0.000 description 2
- 238000003756 stirring Methods 0.000 description 2
- BFSVOASYOCHEOV-UHFFFAOYSA-N 2-diethylaminoethanol Chemical compound CCN(CC)CCO BFSVOASYOCHEOV-UHFFFAOYSA-N 0.000 description 1
- 102000009027 Albumins Human genes 0.000 description 1
- 108010088751 Albumins Proteins 0.000 description 1
- 102000004506 Blood Proteins Human genes 0.000 description 1
- 108010017384 Blood Proteins Proteins 0.000 description 1
- 229920002271 DEAE-Sepharose Polymers 0.000 description 1
- 102000057297 Pepsin A Human genes 0.000 description 1
- 108090000284 Pepsin A Proteins 0.000 description 1
- 239000004698 Polyethylene Substances 0.000 description 1
- 230000004913 activation Effects 0.000 description 1
- 239000000427 antigen Substances 0.000 description 1
- 102000036639 antigens Human genes 0.000 description 1
- 108091007433 antigens Proteins 0.000 description 1
- 239000000440 bentonite Substances 0.000 description 1
- 229910000278 bentonite Inorganic materials 0.000 description 1
- SVPXDRXYRYOSEX-UHFFFAOYSA-N bentoquatam Chemical compound O.O=[Si]=O.O=[Al]O[Al]=O SVPXDRXYRYOSEX-UHFFFAOYSA-N 0.000 description 1
- 238000009739 binding Methods 0.000 description 1
- 229920001400 block copolymer Polymers 0.000 description 1
- 238000007385 chemical modification Methods 0.000 description 1
- 238000004140 cleaning Methods 0.000 description 1
- 230000003247 decreasing effect Effects 0.000 description 1
- 238000011067 equilibration Methods 0.000 description 1
- 238000012869 ethanol precipitation Methods 0.000 description 1
- 238000011049 filling Methods 0.000 description 1
- 238000004108 freeze drying Methods 0.000 description 1
- 229940027941 immunoglobulin g Drugs 0.000 description 1
- 238000002156 mixing Methods 0.000 description 1
- TZBAVQKIEKDGFH-UHFFFAOYSA-N n-[2-(diethylamino)ethyl]-1-benzothiophene-2-carboxamide;hydrochloride Chemical compound [Cl-].C1=CC=C2SC(C(=O)NCC[NH+](CC)CC)=CC2=C1 TZBAVQKIEKDGFH-UHFFFAOYSA-N 0.000 description 1
- 230000007935 neutral effect Effects 0.000 description 1
- 229940111202 pepsin Drugs 0.000 description 1
- 229940012957 plasmin Drugs 0.000 description 1
- 229920001515 polyalkylene glycol Polymers 0.000 description 1
- -1 polyethylene Polymers 0.000 description 1
- 229920000573 polyethylene Polymers 0.000 description 1
- 229920001451 polypropylene glycol Polymers 0.000 description 1
- 239000000843 powder Substances 0.000 description 1
- 239000000047 product Substances 0.000 description 1
- 238000005932 reductive alkylation reaction Methods 0.000 description 1
- 210000002966 serum Anatomy 0.000 description 1
- 239000003381 stabilizer Substances 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
- 238000006277 sulfonation reaction Methods 0.000 description 1
- 239000013589 supplement Substances 0.000 description 1
- 230000002747 voluntary effect Effects 0.000 description 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 1
- 229920003169 water-soluble polymer Polymers 0.000 description 1
- 238000010626 work up procedure Methods 0.000 description 1
Classifications
-
- 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
- Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- Health & Medical Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Biochemistry (AREA)
- Biophysics (AREA)
- Life Sciences & Earth Sciences (AREA)
- Genetics & Genomics (AREA)
- Medicinal Chemistry (AREA)
- Molecular Biology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Immunology (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP14968883A JPS6042336A (ja) | 1983-08-18 | 1983-08-18 | 免疫グロブリンの製造方法 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| DE3430320A1 true DE3430320A1 (de) | 1985-03-28 |
Family
ID=15480636
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DE19843430320 Withdrawn DE3430320A1 (de) | 1983-08-18 | 1984-08-17 | Verfahren zur herstellung von immunglobulin-praeparaten mit verminderter komplementaktivitaet |
Country Status (2)
| Country | Link |
|---|---|
| JP (1) | JPS6042336A (enrdf_load_stackoverflow) |
| DE (1) | DE3430320A1 (enrdf_load_stackoverflow) |
Cited By (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE3641115A1 (de) * | 1986-12-02 | 1988-06-16 | Lentia Gmbh | Verfahren zur herstellung eines intravenoes anwendbaren und in fluessiger form stabilen immunglobulins |
| US5525519A (en) * | 1992-01-07 | 1996-06-11 | Middlesex Sciences, Inc. | Method for isolating biomolecules from a biological sample with linear polymers |
| US7138120B2 (en) | 1998-06-09 | 2006-11-21 | Statens Serum Institut | Process for producing immunoglobulins for intravenous administration and other immunoglobulin products |
| US8715652B2 (en) | 2003-11-18 | 2014-05-06 | Csl Behring Ag | Immunoglobulin preparations having increased stability |
| US9241897B2 (en) | 2010-02-04 | 2016-01-26 | Csl Behring Ag | Immunoglobulin preparation |
| US9422364B2 (en) | 2010-02-26 | 2016-08-23 | Csl Behring Ag | Immunoglobulin preparation and storage system for an immunoglobulin preparation |
| US9631007B2 (en) | 2005-05-25 | 2017-04-25 | Hoffmann-La-Roche Inc. | Method for the purification of antibodies |
| US12144861B2 (en) | 2014-12-03 | 2024-11-19 | Csl Behring Ag | Pharmaceutical product with increased stability comprising immunoglobulins |
Families Citing this family (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE3825429C2 (de) * | 1988-07-27 | 1994-02-10 | Biotest Pharma Gmbh | Verfahren zur Herstellung eines intravenös verabreichbaren polyklonalen Immunglobulin-Präparates mit hohem IgM-Gehalt |
| US6441144B1 (en) * | 1999-05-20 | 2002-08-27 | Alpha Therapeutic Corporation | Method for repairing dual virally inactivated immune globulin for intravenous administration |
| JP2005320248A (ja) * | 2002-04-22 | 2005-11-17 | Mitsubishi Pharma Corp | 免疫グロブリン製剤の製造方法 |
-
1983
- 1983-08-18 JP JP14968883A patent/JPS6042336A/ja active Granted
-
1984
- 1984-08-17 DE DE19843430320 patent/DE3430320A1/de not_active Withdrawn
Cited By (17)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE3641115A1 (de) * | 1986-12-02 | 1988-06-16 | Lentia Gmbh | Verfahren zur herstellung eines intravenoes anwendbaren und in fluessiger form stabilen immunglobulins |
| US4880913A (en) * | 1986-12-02 | 1989-11-14 | Schwab & Co. Ges.M.B.H. | Process for the preparation of an immunoglobulin which can be administered intravenously and is stable in liquid form |
| US5525519A (en) * | 1992-01-07 | 1996-06-11 | Middlesex Sciences, Inc. | Method for isolating biomolecules from a biological sample with linear polymers |
| US5599719A (en) * | 1992-01-07 | 1997-02-04 | Middlesex Sciences, Inc. | Method for isolating biomolecules from a biological sample with linear polymers |
| US7138120B2 (en) | 1998-06-09 | 2006-11-21 | Statens Serum Institut | Process for producing immunoglobulins for intravenous administration and other immunoglobulin products |
| US8715652B2 (en) | 2003-11-18 | 2014-05-06 | Csl Behring Ag | Immunoglobulin preparations having increased stability |
| US8906368B2 (en) | 2003-11-18 | 2014-12-09 | Zlb Behring Ag | Immunoglobulin preparations having increased stability |
| NO345362B1 (no) * | 2005-05-25 | 2020-12-28 | Hoffmann La Roche | Fremgangsmåte for rensing av antistoffer |
| US9631007B2 (en) | 2005-05-25 | 2017-04-25 | Hoffmann-La-Roche Inc. | Method for the purification of antibodies |
| US11034754B2 (en) | 2005-05-25 | 2021-06-15 | Hoffmann-La Roche Inc. | Method for the purification of antibodies |
| US10137197B2 (en) | 2010-02-04 | 2018-11-27 | Csl Behring Ag | Process for preparing an immunoglobulin preparation |
| US9241897B2 (en) | 2010-02-04 | 2016-01-26 | Csl Behring Ag | Immunoglobulin preparation |
| US12194101B2 (en) | 2010-02-04 | 2025-01-14 | Csl Behring Ag | Process for preparing an immunoglobulin preparation |
| US9422364B2 (en) | 2010-02-26 | 2016-08-23 | Csl Behring Ag | Immunoglobulin preparation and storage system for an immunoglobulin preparation |
| US10434176B2 (en) | 2010-02-26 | 2019-10-08 | Csl Behring Ag | Immunoglobulin preparation and storage system for an immunoglobulin preparation |
| US11419936B2 (en) | 2010-02-26 | 2022-08-23 | Csl Behring Ag | Immunoglobulin preparation and storage system for an immunoglobulin preparation |
| US12144861B2 (en) | 2014-12-03 | 2024-11-19 | Csl Behring Ag | Pharmaceutical product with increased stability comprising immunoglobulins |
Also Published As
| Publication number | Publication date |
|---|---|
| JPS6042336A (ja) | 1985-03-06 |
| JPH0582367B2 (enrdf_load_stackoverflow) | 1993-11-18 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| 8128 | New person/name/address of the agent |
Representative=s name: VOSSIUS, V., DIPL.-CHEM. DR.RER.NAT. TAUCHNER, P., |
|
| 8141 | Disposal/no request for examination |