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
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- 239000012465 retentate Substances 0.000 claims description 25
- 239000000463 material Substances 0.000 claims description 17
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- 150000001450 anions Chemical class 0.000 claims description 11
- 150000001768 cations Chemical class 0.000 claims description 10
- 239000012141 concentrate Substances 0.000 claims description 8
- 238000004519 manufacturing process Methods 0.000 claims description 6
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- 102000039446 nucleic acids Human genes 0.000 claims description 5
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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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- 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
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- 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
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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
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- 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
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 |
|---|---|
| HUE029197T2 true HUE029197T2 (hu) | 2017-02-28 |
Family
ID=41463102
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| 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 |
|---|---|---|---|---|
| CA2772846C (en) | 2009-09-29 | 2020-09-29 | F. Hoffmann-La Roche Ag | Pre-filtration adjustment of buffer solutes |
| 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) |
| JP7419354B2 (ja) * | 2018-10-24 | 2024-01-22 | エフ． ホフマン－ラ ロシュ アーゲー | オリゴヌクレオチドの精製プロセス |
Family Cites Families (12)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CA1263072A (en) | 1984-06-22 | 1989-11-21 | Richard L. Veech | Hemodialysis processes and hemodialysis solutions |
| US5256294A (en) * | 1990-09-17 | 1993-10-26 | Genentech, Inc. | Tangential flow filtration process and apparatus |
| US6113898A (en) | 1995-06-07 | 2000-09-05 | Idec Pharmaceuticals Corporation | Human B7.1-specific primatized antibodies and transfectomas expressing said antibodies |
| WO2003039486A2 (en) | 2001-11-09 | 2003-05-15 | Idec Pharmaceuticals Corporation | Anti-cd80 antibody having adcc activity for adcc mediated killing of b cell lymphoma cells alone or in combination with other therapies |
| AR038568A1 (es) | 2002-02-20 | 2005-01-19 | Hoffmann La Roche | Anticuerpos anti-a beta y su uso |
| CN1671741A (zh) | 2002-06-21 | 2005-09-21 | 拜奥根Idec公司 | 浓缩抗体的缓冲剂制剂及其使用方法 |
| DK1737891T3 (da) | 2004-04-13 | 2013-03-25 | Hoffmann La Roche | Anti-p-selectin-antistoffer |
| US20060051347A1 (en) | 2004-09-09 | 2006-03-09 | Winter Charles M | Process for concentration of antibodies and therapeutic products thereof |
| EP2170949B1 (en) * | 2007-07-17 | 2012-12-26 | F. Hoffmann - La Roche AG | Variable tangential flow filtration |
| CN101874040A (zh) | 2007-11-29 | 2010-10-27 | 弗·哈夫曼-拉罗切有限公司 | 免疫球蛋白聚集体 |
| KR20190045414A (ko) | 2007-11-30 | 2019-05-02 | 애브비 바이오테크놀로지 리미티드 | 단백질 제형 및 이의 제조방법 |
| CA2772846C (en) | 2009-09-29 | 2020-09-29 | F. Hoffmann-La Roche Ag | Pre-filtration adjustment of buffer solutes |
-
2010
- 2010-08-27 CA CA2772846A patent/CA2772846C/en active Active
- 2010-08-27 PL PL10745660.0T patent/PL2483304T3/pl unknown
- 2010-08-27 ES ES10745660.0T patent/ES2582581T3/es active Active
- 2010-08-27 EP EP10745660.0A patent/EP2483304B1/en active Active
- 2010-08-27 HU HUE10745660A patent/HUE029197T2/hu unknown
- 2010-08-27 CN CN201080042449.4A patent/CN102574912B/zh active Active
- 2010-08-27 DK DK10745660.0T patent/DK2483304T3/en active
- 2010-08-27 WO PCT/EP2010/062554 patent/WO2011039012A1/en active Application Filing
- 2010-08-27 SI SI201031216A patent/SI2483304T1/sl unknown
- 2010-08-27 US US13/395,893 patent/US8822655B2/en active Active
- 2010-08-27 JP JP2012530201A patent/JP5697268B2/ja active Active
Also Published As
| Publication number | Publication date |
|---|---|
| CA2772846A1 (en) | 2011-04-07 |
| JP2013505905A (ja) | 2013-02-21 |
| CN102574912B (zh) | 2014-12-24 |
| EP2483304B1 (en) | 2016-05-04 |
| ES2582581T3 (es) | 2016-09-13 |
| CA2772846C (en) | 2020-09-29 |
| DK2483304T3 (en) | 2016-05-30 |
| CN102574912A (zh) | 2012-07-11 |
| US20120219990A1 (en) | 2012-08-30 |
| EP2483304A1 (en) | 2012-08-08 |
| SI2483304T1 (sl) | 2016-08-31 |
| PL2483304T3 (pl) | 2016-11-30 |
| WO2011039012A1 (en) | 2011-04-07 |
| US8822655B2 (en) | 2014-09-02 |
| JP5697268B2 (ja) | 2015-04-08 |
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