HRP20160815T1 - Postupak pročišćavanja ugljikohidrata iz skupine a streptokoka - Google Patents
Postupak pročišćavanja ugljikohidrata iz skupine a streptokoka Download PDFInfo
- Publication number
- HRP20160815T1 HRP20160815T1 HRP20160815TT HRP20160815T HRP20160815T1 HR P20160815 T1 HRP20160815 T1 HR P20160815T1 HR P20160815T T HRP20160815T T HR P20160815TT HR P20160815 T HRP20160815 T HR P20160815T HR P20160815 T1 HRP20160815 T1 HR P20160815T1
- Authority
- HR
- Croatia
- Prior art keywords
- anion exchange
- exchange chromatography
- steps
- gas
- gel filtration
- Prior art date
Links
- 238000000034 method Methods 0.000 title claims 19
- 241001505901 Streptococcus sp. 'group A' Species 0.000 title claims 12
- 150000001720 carbohydrates Chemical class 0.000 title claims 12
- 238000000746 purification Methods 0.000 title 1
- 238000005571 anion exchange chromatography Methods 0.000 claims 10
- 235000014633 carbohydrates Nutrition 0.000 claims 10
- 238000002523 gelfiltration Methods 0.000 claims 7
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims 5
- 239000011159 matrix material Substances 0.000 claims 4
- 238000001914 filtration Methods 0.000 claims 3
- 238000005349 anion exchange Methods 0.000 claims 2
- 238000009295 crossflow filtration Methods 0.000 claims 2
- 239000012528 membrane Substances 0.000 claims 2
- 239000011347 resin Substances 0.000 claims 2
- 229920005989 resin Polymers 0.000 claims 2
- 238000000108 ultra-filtration Methods 0.000 claims 2
- KIUKXJAPPMFGSW-DNGZLQJQSA-N (2S,3S,4S,5R,6R)-6-[(2S,3R,4R,5S,6R)-3-Acetamido-2-[(2S,3S,4R,5R,6R)-6-[(2R,3R,4R,5S,6R)-3-acetamido-2,5-dihydroxy-6-(hydroxymethyl)oxan-4-yl]oxy-2-carboxy-4,5-dihydroxyoxan-3-yl]oxy-5-hydroxy-6-(hydroxymethyl)oxan-4-yl]oxy-3,4,5-trihydroxyoxane-2-carboxylic acid Chemical compound CC(=O)N[C@H]1[C@H](O)O[C@H](CO)[C@@H](O)[C@@H]1O[C@H]1[C@H](O)[C@@H](O)[C@H](O[C@H]2[C@@H]([C@@H](O[C@H]3[C@@H]([C@@H](O)[C@H](O)[C@H](O3)C(O)=O)O)[C@H](O)[C@@H](CO)O2)NC(C)=O)[C@@H](C(O)=O)O1 KIUKXJAPPMFGSW-DNGZLQJQSA-N 0.000 claims 1
- 229920005654 Sephadex Polymers 0.000 claims 1
- 241000193996 Streptococcus pyogenes Species 0.000 claims 1
- 238000010306 acid treatment Methods 0.000 claims 1
- 239000007900 aqueous suspension Substances 0.000 claims 1
- 230000001268 conjugating effect Effects 0.000 claims 1
- 239000003937 drug carrier Substances 0.000 claims 1
- 229920002674 hyaluronan Polymers 0.000 claims 1
- 229960003160 hyaluronic acid Drugs 0.000 claims 1
- 239000000825 pharmaceutical preparation Substances 0.000 claims 1
- 230000002829 reductive effect Effects 0.000 claims 1
- 239000007858 starting material Substances 0.000 claims 1
- 239000000725 suspension Substances 0.000 claims 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K39/02—Bacterial antigens
- A61K39/09—Lactobacillales, e.g. aerococcus, enterococcus, lactobacillus, lactococcus, streptococcus
- A61K39/092—Streptococcus
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/04—Antibacterial agents
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01D—SEPARATION
- B01D15/00—Separating processes involving the treatment of liquids with solid sorbents; Apparatus therefor
- B01D15/08—Selective adsorption, e.g. chromatography
- B01D15/26—Selective adsorption, e.g. chromatography characterised by the separation mechanism
- B01D15/34—Size selective separation, e.g. size exclusion chromatography, gel filtration, permeation
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01D—SEPARATION
- B01D15/00—Separating processes involving the treatment of liquids with solid sorbents; Apparatus therefor
- B01D15/08—Selective adsorption, e.g. chromatography
- B01D15/26—Selective adsorption, e.g. chromatography characterised by the separation mechanism
- B01D15/36—Selective adsorption, e.g. chromatography characterised by the separation mechanism involving ionic interaction
- B01D15/361—Ion-exchange
- B01D15/363—Anion-exchange
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K2039/555—Medicinal preparations containing antigens or antibodies characterised by a specific combination antigen/adjuvant
- A61K2039/55505—Inorganic adjuvants
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K2039/60—Medicinal preparations containing antigens or antibodies characteristics by the carrier linked to the antigen
- A61K2039/6031—Proteins
- A61K2039/6037—Bacterial toxins, e.g. diphteria toxoid [DT], tetanus toxoid [TT]
-
- 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
- B01D61/145—Ultrafiltration
Claims (12)
1. Postupak priprave farmaceutskog pripravka, naznačen time što se sastoji u koracima miješanja ugljikohidrata iz skupine A streptokoka (GAS) s farmaceutski prihvatljivim nosačem, gdje se GAS ugljikohidrat je pročišćuje u postupku koji se sastoji u koraku anionskoizmjenjivačke kromatografije.
2. Postupak u skladu s patentnim zahtjevom 1, naznačen time što pročišćeni GAS ugljikohidrat ima molekulsku težinu od otprilike 10 kDa.
3. Postupak u skladu s patentnim zahtjevom 1 ili patentnim zahtjevom 2, naznačen time što je saharid djelomično ili u potpunosti de-N-acetiliran.
4. Postupak u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačen time što je polazni materijal vodena suspenzija GAS ugljikohidrata, koja dodatno sadrži hijaluronsku kiselinu i/ili poliramnozu, gdje se suspenziju može pripraviti takvom obradom bakterije Streptococcus pyogenes da se GAS ugljikohidrat otpušta reduktivnom obradom kiselinom.
5. Postupak u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačen time što se postupak sastoji od jednog ili više koraka filtriranja prije koraka anionskoizmjenjivačke kromatografije, gdje filtriranje može biti ortogonalno filtriranje, uz upotrebu 0,65 µm filtra.
6. Postupak u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačen time što se postupak sastoji od jednog ili više koraka ultrafiltriranja prije koraka anionskoizmjenjivačke kromatografije, gdje ultrafiltriranje može biti filtriranje tangencijalnim protokom uz upotrebu membrane za ograničavanje 30 kDa.
7. Postupak u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačen time što
(a) korak anionskoizmjenjivačke kromatografije se provodi uz upotrebu Q-smole kao matriksa za anionsku izmjenu; i/ili
(b) korak anionskoizmjenjivačke kromatografije se provodi uz upotrebu 1 ml smole kao matriksa za anionsku izmjenu za svaki 1 mg GAS ugljikohidrata; i/ili
(c) korak anionskoizmjenjivačke kromatografije se provodi u uvjetima koji omogućuju prolaženje GAS ugljikohidrata.
8. Postupak u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačen time što pufer kao pokretna faza za anionskoizmjenjivačku kromatografiju sadrži alkohol, gdje konačna koncentracija alkohola u puferu kao pokretnoj fazi je između 15% i 25%, te gdje alkohol može biti etanol.
9. Postupak u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačen time što se postupak sastoji od jednog ili više koraka filtriranja na gelu nakon koraka anionskoizmjenjivačke kromatografije, gdje se jedan ili više koraka filtriranja na gelu može provesti uz upotrebu dekstranskog gelsa kao matriksa za filtriranje na gelu, te gdje se jedan ili više koraka filtriranja na gelu može provesti uz upotrebu 1 ml matriksa za filtriranje na gelu za svaka 0,2 mg GAS ugljikohidrata.
10. Postupak u skladu s patentnim zahtjevom 9, naznačen time što
(a) jedan ili više koraka filtriranja na gelu se provodi uz upotrebu istog pufera kao pokretne faze kao korak anionskoizmjenjivačke kromatografije; i/ili
(b) jedan ili više koraka filtriranja na gelu se provodi uz upotrebu pufera kao pokretne faze, kao što je definirano u patentnom zahtjevu 8.
11. Postupak u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačen time što se postupak sastoji od jednog ili više koraka koncentriranja GAS ugljikohidrata nakon koraka anionskoizmjenjivačke kromatografije, gdje se jedan ili više koraka koncentriranja može provesti filtriranjem tangencijalnim protokom uz upotrebu membrane za ograničavanje 5 ili 10 kDa.
12. Postupak u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačen time što postupak uključuje dodatni korak konjugiranja pročišćenog GAS ugljikohidrata s molekulom nosača.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US10876308P | 2008-10-27 | 2008-10-27 | |
| EP09764294.6A EP2349520B1 (en) | 2008-10-27 | 2009-10-27 | Purification method for carbohydrate from group a streptococcus |
| PCT/IB2009/007346 WO2010049806A1 (en) | 2008-10-27 | 2009-10-27 | Purification method |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20160815T1 true HRP20160815T1 (hr) | 2016-09-23 |
Family
ID=41692891
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20160815TT HRP20160815T1 (hr) | 2008-10-27 | 2016-07-07 | Postupak pročišćavanja ugljikohidrata iz skupine a streptokoka |
Country Status (16)
| Country | Link |
|---|---|
| US (1) | US11065323B2 (hr) |
| EP (1) | EP2349520B1 (hr) |
| JP (1) | JP5689064B2 (hr) |
| CN (1) | CN102264444B (hr) |
| AU (1) | AU2009309416B2 (hr) |
| BR (1) | BRPI0920524A2 (hr) |
| CA (1) | CA2777837C (hr) |
| CY (1) | CY1117906T1 (hr) |
| DK (1) | DK2349520T3 (hr) |
| ES (1) | ES2586308T3 (hr) |
| HR (1) | HRP20160815T1 (hr) |
| HU (1) | HUE029265T2 (hr) |
| PL (1) | PL2349520T3 (hr) |
| PT (1) | PT2349520T (hr) |
| SI (1) | SI2349520T1 (hr) |
| WO (1) | WO2010049806A1 (hr) |
Families Citing this family (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EA202192401A1 (ru) | 2019-04-02 | 2022-03-30 | Ваксайт, Инк. | Оптимизированный бесклеточный синтез плазмидного антигена инвазии в и родственные композиции и способы применения |
| BR112022016268A2 (pt) | 2020-02-18 | 2022-10-11 | Vaxcyte Inc | Composições imunogênicas de strep do grupo a com conjugados de polisacarídeo-proteína |
| CA3208716A1 (en) * | 2021-02-17 | 2022-08-25 | Peter T. Davey | Purification processes for polysaccharides and polypeptide conjugates thereof |
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-
2009
- 2009-10-27 DK DK09764294.6T patent/DK2349520T3/en active
- 2009-10-27 SI SI200931480A patent/SI2349520T1/sl unknown
- 2009-10-27 PT PT97642946T patent/PT2349520T/pt unknown
- 2009-10-27 HU HUE09764294A patent/HUE029265T2/en unknown
- 2009-10-27 EP EP09764294.6A patent/EP2349520B1/en active Active
- 2009-10-27 ES ES09764294.6T patent/ES2586308T3/es active Active
- 2009-10-27 CA CA2777837A patent/CA2777837C/en active Active
- 2009-10-27 CN CN200980153125.5A patent/CN102264444B/zh not_active Expired - Fee Related
- 2009-10-27 BR BRPI0920524A patent/BRPI0920524A2/pt not_active IP Right Cessation
- 2009-10-27 PL PL09764294T patent/PL2349520T3/pl unknown
- 2009-10-27 WO PCT/IB2009/007346 patent/WO2010049806A1/en active Application Filing
- 2009-10-27 JP JP2011532737A patent/JP5689064B2/ja active Active
- 2009-10-27 AU AU2009309416A patent/AU2009309416B2/en active Active
- 2009-10-27 US US13/126,146 patent/US11065323B2/en active Active
-
2016
- 2016-07-07 HR HRP20160815TT patent/HRP20160815T1/hr unknown
- 2016-07-19 CY CY20161100708T patent/CY1117906T1/el unknown
Also Published As
| Publication number | Publication date |
|---|---|
| US20120010398A1 (en) | 2012-01-12 |
| JP5689064B2 (ja) | 2015-03-25 |
| CN102264444B (zh) | 2015-08-05 |
| HUE029265T2 (en) | 2017-02-28 |
| PL2349520T3 (pl) | 2017-08-31 |
| ES2586308T3 (es) | 2016-10-13 |
| WO2010049806A1 (en) | 2010-05-06 |
| CN102264444A (zh) | 2011-11-30 |
| EP2349520B1 (en) | 2016-05-25 |
| EP2349520A1 (en) | 2011-08-03 |
| CY1117906T1 (el) | 2017-05-17 |
| SI2349520T1 (sl) | 2016-08-31 |
| US11065323B2 (en) | 2021-07-20 |
| CA2777837C (en) | 2017-07-11 |
| DK2349520T3 (en) | 2016-08-15 |
| PT2349520T (pt) | 2016-08-16 |
| AU2009309416A1 (en) | 2010-05-06 |
| AU2009309416B2 (en) | 2015-05-28 |
| CA2777837A1 (en) | 2010-05-06 |
| BRPI0920524A2 (pt) | 2015-12-22 |
| JP2012506853A (ja) | 2012-03-22 |
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