HUE029197T2 - Oldott pufferanyagok elõszûréssel történõ beállítása nagy koncentrációjú immunglobulin készítményhez - Google Patents
Oldott pufferanyagok elõszûréssel történõ beállítása nagy koncentrációjú immunglobulin készítményhez Download PDFInfo
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- HUE029197T2 HUE029197T2 HUE10745660A HUE10745660A HUE029197T2 HU E029197 T2 HUE029197 T2 HU E029197T2 HU E10745660 A HUE10745660 A HU E10745660A HU E10745660 A HUE10745660 A HU E10745660A HU E029197 T2 HUE029197 T2 HU E029197T2
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- 108060003951 Immunoglobulin Proteins 0.000 title claims description 93
- 102000018358 immunoglobulin Human genes 0.000 title claims description 93
- 239000000872 buffer Substances 0.000 title claims description 60
- 238000002360 preparation method Methods 0.000 title description 6
- 238000011045 prefiltration Methods 0.000 title description 3
- 238000000034 method Methods 0.000 claims description 71
- 108090000623 proteins and genes Proteins 0.000 claims description 69
- 102000004169 proteins and genes Human genes 0.000 claims description 68
- 238000009295 crossflow filtration Methods 0.000 claims description 39
- 230000008569 process Effects 0.000 claims description 31
- 239000012465 retentate Substances 0.000 claims description 25
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- 150000001450 anions Chemical class 0.000 claims description 11
- 150000001768 cations Chemical class 0.000 claims description 10
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- 102000039446 nucleic acids Human genes 0.000 claims description 5
- 108020004707 nucleic acids Proteins 0.000 claims description 5
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- 102000003800 Selectins Human genes 0.000 claims description 2
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- AAEVYOVXGOFMJO-UHFFFAOYSA-N prometryn Chemical compound CSC1=NC(NC(C)C)=NC(NC(C)C)=N1 AAEVYOVXGOFMJO-UHFFFAOYSA-N 0.000 claims description 2
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- 238000000108 ultra-filtration Methods 0.000 description 51
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- 108090000765 processed proteins & peptides Proteins 0.000 description 21
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 description 20
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- 238000002474 experimental method Methods 0.000 description 11
- HNSDLXPSAYFUHK-UHFFFAOYSA-N 1,4-bis(2-ethylhexyl) sulfosuccinate Chemical compound CCCCC(CC)COC(=O)CC(S(O)(=O)=O)C(=O)OCC(CC)CCCC HNSDLXPSAYFUHK-UHFFFAOYSA-N 0.000 description 9
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- HNDVDQJCIGZPNO-YFKPBYRVSA-N L-histidine Chemical compound OC(=O)[C@@H](N)CC1=CN=CN1 HNDVDQJCIGZPNO-YFKPBYRVSA-N 0.000 description 3
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- 108700005091 Immunoglobulin Genes Proteins 0.000 description 2
- NBIIXXVUZAFLBC-UHFFFAOYSA-N Phosphoric acid Chemical compound OP(O)(O)=O NBIIXXVUZAFLBC-UHFFFAOYSA-N 0.000 description 2
- WCUXLLCKKVVCTQ-UHFFFAOYSA-M Potassium chloride Chemical compound [Cl-].[K+] WCUXLLCKKVVCTQ-UHFFFAOYSA-M 0.000 description 2
- 241000700605 Viruses Species 0.000 description 2
- 125000003275 alpha amino acid group Chemical group 0.000 description 2
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- 125000001424 substituent group Chemical group 0.000 description 2
- 239000006228 supernatant Substances 0.000 description 2
- LWIHDJKSTIGBAC-UHFFFAOYSA-K tripotassium phosphate Chemical compound [K+].[K+].[K+].[O-]P([O-])([O-])=O LWIHDJKSTIGBAC-UHFFFAOYSA-K 0.000 description 2
- 125000000022 2-aminoethyl group Chemical group [H]C([*])([H])C([H])([H])N([H])[H] 0.000 description 1
- HJPIFBJPTYTSEX-UHFFFAOYSA-N 2h-tetracen-1-one Chemical compound C1=CC=C2C=C(C=C3C(=O)CC=CC3=C3)C3=CC2=C1 HJPIFBJPTYTSEX-UHFFFAOYSA-N 0.000 description 1
- 101001028764 Arabidopsis thaliana Mitochondrial phosphate carrier protein 2, mitochondrial Proteins 0.000 description 1
- DGAQECJNVWCQMB-PUAWFVPOSA-M Ilexoside XXIX Chemical compound C[C@@H]1CC[C@@]2(CC[C@@]3(C(=CC[C@H]4[C@]3(CC[C@@H]5[C@@]4(CC[C@@H](C5(C)C)OS(=O)(=O)[O-])C)C)[C@@H]2[C@]1(C)O)C)C(=O)O[C@H]6[C@@H]([C@H]([C@@H]([C@H](O6)CO)O)O)O.[Na+] DGAQECJNVWCQMB-PUAWFVPOSA-M 0.000 description 1
- 102000008394 Immunoglobulin Fragments Human genes 0.000 description 1
- 108010021625 Immunoglobulin Fragments Proteins 0.000 description 1
- 102000006496 Immunoglobulin Heavy Chains Human genes 0.000 description 1
- 108010019476 Immunoglobulin Heavy Chains Proteins 0.000 description 1
- 102000013463 Immunoglobulin Light Chains Human genes 0.000 description 1
- 108010065825 Immunoglobulin Light Chains Proteins 0.000 description 1
- 108010067060 Immunoglobulin Variable Region Proteins 0.000 description 1
- 240000007594 Oryza sativa Species 0.000 description 1
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- 229920002684 Sepharose Polymers 0.000 description 1
- 101710120037 Toxin CcdB Proteins 0.000 description 1
- LPQOADBMXVRBNX-UHFFFAOYSA-N ac1ldcw0 Chemical compound Cl.C1CN(C)CCN1C1=C(F)C=C2C(=O)C(C(O)=O)=CN3CCSC1=C32 LPQOADBMXVRBNX-UHFFFAOYSA-N 0.000 description 1
- 238000009825 accumulation Methods 0.000 description 1
- 239000008186 active pharmaceutical agent Substances 0.000 description 1
- 238000005377 adsorption chromatography Methods 0.000 description 1
- 229910000147 aluminium phosphate Inorganic materials 0.000 description 1
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- 125000003118 aryl group Chemical group 0.000 description 1
- 229960000074 biopharmaceutical Drugs 0.000 description 1
- 239000008366 buffered solution Substances 0.000 description 1
- 150000001720 carbohydrates Chemical class 0.000 description 1
- 235000014633 carbohydrates Nutrition 0.000 description 1
- 125000002057 carboxymethyl group Chemical group [H]OC(=O)C([H])([H])[*] 0.000 description 1
- 238000005341 cation exchange Methods 0.000 description 1
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- 239000003446 ligand Substances 0.000 description 1
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- JMZFEHDNIAQMNB-UHFFFAOYSA-N m-aminophenylboronic acid Chemical compound NC1=CC=CC(B(O)O)=C1 JMZFEHDNIAQMNB-UHFFFAOYSA-N 0.000 description 1
- 229920002521 macromolecule Polymers 0.000 description 1
- 229910052751 metal Inorganic materials 0.000 description 1
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- 229920000642 polymer Polymers 0.000 description 1
- 239000001103 potassium chloride Substances 0.000 description 1
- 235000011164 potassium chloride Nutrition 0.000 description 1
- 229910000160 potassium phosphate Inorganic materials 0.000 description 1
- 235000011009 potassium phosphates Nutrition 0.000 description 1
- 238000011165 process development Methods 0.000 description 1
- 108020003175 receptors Proteins 0.000 description 1
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- 150000003839 salts Chemical class 0.000 description 1
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- 229910052708 sodium Inorganic materials 0.000 description 1
- 239000011734 sodium Substances 0.000 description 1
- 239000007974 sodium acetate buffer Substances 0.000 description 1
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- 239000003053 toxin Substances 0.000 description 1
- 231100000765 toxin Toxicity 0.000 description 1
- LENZDBCJOHFCAS-UHFFFAOYSA-N tris Chemical compound OCC(N)(CO)CO LENZDBCJOHFCAS-UHFFFAOYSA-N 0.000 description 1
- DGVVWUTYPXICAM-UHFFFAOYSA-N β‐Mercaptoethanol Chemical compound OCCS DGVVWUTYPXICAM-UHFFFAOYSA-N 0.000 description 1
Classifications
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K1/00—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
- C07K1/14—Extraction; Separation; Purification
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K1/00—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
- C07K1/14—Extraction; Separation; Purification
- C07K1/34—Extraction; Separation; Purification by filtration, ultrafiltration or reverse osmosis
-
- 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
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01D—SEPARATION
- B01D61/00—Processes of separation using semi-permeable membranes, e.g. dialysis, osmosis or ultrafiltration; Apparatus, accessories or auxiliary operations specially adapted therefor
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01D—SEPARATION
- B01D61/00—Processes of separation using semi-permeable membranes, e.g. dialysis, osmosis or ultrafiltration; Apparatus, accessories or auxiliary operations specially adapted therefor
- B01D61/14—Ultrafiltration; Microfiltration
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
- C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
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- Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- Health & Medical Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Life Sciences & Earth Sciences (AREA)
- Biochemistry (AREA)
- Biophysics (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Genetics & Genomics (AREA)
- Molecular Biology (AREA)
- Analytical Chemistry (AREA)
- Engineering & Computer Science (AREA)
- Water Supply & Treatment (AREA)
- Immunology (AREA)
- Peptides Or Proteins (AREA)
- Preparation Of Compounds By Using Micro-Organisms (AREA)
Claims (6)
- Äz EP 2 483 384 lajstromszámú európai szabadalom igénypontjainak fordítása:1, Eljárás immunglobulin-oldat koncentrálására, amely tartalmazza a következő aj veszünk egy immunglobulin oldatot egy bizonyos pH-értékket, egy első Immunglobulin pmíein-koneentráeíovat és egy első S" vagy S" pyfer anyagkoncentrációval , b) beálfliuk a pufferanyag első koncentrációját egy második S: koncentrációra, és a pH-ériéket fermtaníok, aboi a második S’ koncentrációt a 2 egyenlet segítségével számítjuk, amennyiben a puffer anyag egy katíen/sem leges pár, vagy a 3 egyenlet segítségével, amennyiben a puffer anyag: egy semfegés/anion pár, c) koncentráljuk a b) lépés szerinti oldatot tangencíáíts (keresztáramú) szűréssel (tangential flow filtration) egy második immunglobulin protein koncentrációra, ahol a 2 egyenletés a 3 egyenletahol a mőikoncenfráelő a pozitivan/negatívan töltői oldott anyagok retentátumában (S^fS' }, a protein töltése (z), a protein môikoncentrâcioia (P) és a molekulatömege (M? j, az oldat sűrűsége a retentátumban (pj és a permeátumhan (p’j, és a dii&zibiSis oldott anyag elméleti mőfkoncentráoiöja (S ), ahol a diffúzibíiis oldott anyag elméleti mólkoncentrációját, S'~l egy korrekciós fényezővel korrigáljuk, ahol az egyes pH-értékeknél bekövetkező relatív növekedést használjuk megfelelő korrekciós faktorként, ahol a puffer aoionjpyffer kation és a puffer sav kőzőil arányt számíthatjuk a retenfafumban meghatározott egyes pH-értékekre a Ne ndersön-Hasseibach-Egyenlet segítségévei, és az egyes pH- értékeknél bekövetkező relatív növekedést használhatjuk megfelelő korrekciós faktortént
- 2, Az 1, Igénypont szerinti eljárás, azzal jellemezve, hogy a puffer anyag biszlidin, és a második koncentrációt a 2 egyenlettel szám Ifjúk.
- 3, Az 1, vagy 2. Igénypont szedni eljárás, azzal jellemezve, hogy az első koncentráció 20 raM. 4. A 3, Igénypont szedni eljárás, azzal jellemezve, hogy a második koncentráció 2.4 mM - 37 mM
- 5. Az I. vagy 2.: igénypontok bármelyike szerinti eljárás, azzal jellemezve, hogy az első koncentráció 46 mM.
- 8, Az 5. igénypont szerinti eljárás, azzal jellemezve, hogy a második koncentráció $2 mi - 72 mM. 7< Az 1.. igénypont szerinti eljárás, azzal jellemezve, hogy a puffer anyag seeták és a koncentrációt á 3 egyenlettel számítjuk. 8* A 7. Igénypont szerinti eljárás, azzal jellemezve, hegy az első koncentráció 26 mi, 9:. A 8. igénypont szerinti eljárás, azzal jellemezve, hogy a második koncentráció § ~ IS mML ttv k 7. igénypont szerinti leprás, azzal jellemezve, hegyez első koncentráció 45 mfvt 11. A11, igénypont szerinti eljárás, azzal jellemezve, hogy a második koncentráció 41 mM - 48 mM. 12:. Az előző igénypontok bármelyike szedni eljárás, azzal jellemezve, hogy az Immunglobulin egy anti-P szelektin antitest: vagy egy anti-Άβ antitest:.
- 13, Eljárás Immunglobulin in vitro előállítására, amely során aj tenyésztünk olyan sejtet, amely az immunglobulint kódoló nukleinsavat tartalmazza, hl kinyerjük az Immunglobulint az a) lépés szedni tenyészkozeghül vagy sejtből, c) tisztítjuk az Immunglobulint, d) koncentráljuk az immunglobulint az 1~12. igénypontok bármelyike .szerinti eljárással, és így immunglobulint állítunk elő.
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP09012316 | 2009-09-29 |
Publications (1)
Publication Number | Publication Date |
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HUE029197T2 true HUE029197T2 (hu) | 2017-02-28 |
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Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
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HUE10745660A HUE029197T2 (hu) | 2009-09-29 | 2010-08-27 | Oldott pufferanyagok elõszûréssel történõ beállítása nagy koncentrációjú immunglobulin készítményhez |
Country Status (11)
Country | Link |
---|---|
US (1) | US8822655B2 (hu) |
EP (1) | EP2483304B1 (hu) |
JP (1) | JP5697268B2 (hu) |
CN (1) | CN102574912B (hu) |
CA (1) | CA2772846C (hu) |
DK (1) | DK2483304T3 (hu) |
ES (1) | ES2582581T3 (hu) |
HU (1) | HUE029197T2 (hu) |
PL (1) | PL2483304T3 (hu) |
SI (1) | SI2483304T1 (hu) |
WO (1) | WO2011039012A1 (hu) |
Families Citing this family (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
ES2582581T3 (es) | 2009-09-29 | 2016-09-13 | F. Hoffmann-La Roche Ag | Ajuste prefiltración de solutos tampón para la preparación de inmunoglobulinas a alta concentración |
EP2833139A1 (en) | 2013-08-01 | 2015-02-04 | SuppreMol GmbH | In vitro method for determining the stability of compositions comprising soluble Fc gamma receptor(s) |
BR112021003998A2 (pt) | 2018-10-24 | 2021-05-25 | F. Hoffmann-La Roche Ag | processo para a purificação de oligonucleotídeos |
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Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
AU4605585A (en) | 1984-06-22 | 1986-01-24 | R.L. Veech | (improved) hemodialysis processes and hemodialysis solutions |
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-
2010
- 2010-08-27 ES ES10745660.0T patent/ES2582581T3/es active Active
- 2010-08-27 WO PCT/EP2010/062554 patent/WO2011039012A1/en active Application Filing
- 2010-08-27 CN CN201080042449.4A patent/CN102574912B/zh active Active
- 2010-08-27 SI SI201031216A patent/SI2483304T1/sl unknown
- 2010-08-27 JP JP2012530201A patent/JP5697268B2/ja active Active
- 2010-08-27 US US13/395,893 patent/US8822655B2/en active Active
- 2010-08-27 PL PL10745660.0T patent/PL2483304T3/pl unknown
- 2010-08-27 DK DK10745660.0T patent/DK2483304T3/en active
- 2010-08-27 CA CA2772846A patent/CA2772846C/en active Active
- 2010-08-27 EP EP10745660.0A patent/EP2483304B1/en active Active
- 2010-08-27 HU HUE10745660A patent/HUE029197T2/hu unknown
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JP5697268B2 (ja) | 2015-04-08 |
WO2011039012A1 (en) | 2011-04-07 |
US8822655B2 (en) | 2014-09-02 |
CA2772846C (en) | 2020-09-29 |
EP2483304B1 (en) | 2016-05-04 |
SI2483304T1 (sl) | 2016-08-31 |
CN102574912A (zh) | 2012-07-11 |
CA2772846A1 (en) | 2011-04-07 |
ES2582581T3 (es) | 2016-09-13 |
EP2483304A1 (en) | 2012-08-08 |
US20120219990A1 (en) | 2012-08-30 |
JP2013505905A (ja) | 2013-02-21 |
PL2483304T3 (pl) | 2016-11-30 |
CN102574912B (zh) | 2014-12-24 |
DK2483304T3 (en) | 2016-05-30 |
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