HRP20201663T1 - PRILAGOĐAVANJE pH VRIJEDNOSTI RADI POBOLJŠANJA OPORAVKA BANAKA STANICA USLIJED ODMRZAVANJA - Google Patents
PRILAGOĐAVANJE pH VRIJEDNOSTI RADI POBOLJŠANJA OPORAVKA BANAKA STANICA USLIJED ODMRZAVANJA Download PDFInfo
- Publication number
- HRP20201663T1 HRP20201663T1 HRP20201663TT HRP20201663T HRP20201663T1 HR P20201663 T1 HRP20201663 T1 HR P20201663T1 HR P20201663T T HRP20201663T T HR P20201663TT HR P20201663 T HRP20201663 T HR P20201663T HR P20201663 T1 HRP20201663 T1 HR P20201663T1
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- Prior art keywords
- freezing medium
- value
- freezing
- medium
- cho cells
- Prior art date
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- 238000010979 pH adjustment Methods 0.000 title 1
- 238000011084 recovery Methods 0.000 title 1
- 239000012595 freezing medium Substances 0.000 claims 31
- IAZDPXIOMUYVGZ-UHFFFAOYSA-N Dimethylsulphoxide Chemical compound CS(C)=O IAZDPXIOMUYVGZ-UHFFFAOYSA-N 0.000 claims 15
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 claims 15
- 210000004978 chinese hamster ovary cell Anatomy 0.000 claims 12
- 238000000034 method Methods 0.000 claims 12
- 210000004027 cell Anatomy 0.000 claims 11
- 238000007710 freezing Methods 0.000 claims 9
- 230000008014 freezing Effects 0.000 claims 9
- CDBYLPFSWZWCQE-UHFFFAOYSA-L Sodium Carbonate Chemical compound [Na+].[Na+].[O-]C([O-])=O CDBYLPFSWZWCQE-UHFFFAOYSA-L 0.000 claims 6
- 229920001184 polypeptide Polymers 0.000 claims 5
- 102000004196 processed proteins & peptides Human genes 0.000 claims 5
- 108090000765 processed proteins & peptides Proteins 0.000 claims 5
- 239000002577 cryoprotective agent Substances 0.000 claims 4
- 102000039446 nucleic acids Human genes 0.000 claims 4
- 108020004707 nucleic acids Proteins 0.000 claims 4
- 150000007523 nucleic acids Chemical class 0.000 claims 4
- LYCAIKOWRPUZTN-UHFFFAOYSA-N Ethylene glycol Chemical compound OCCO LYCAIKOWRPUZTN-UHFFFAOYSA-N 0.000 claims 3
- KWYUFKZDYYNOTN-UHFFFAOYSA-M Potassium hydroxide Chemical compound [OH-].[K+] KWYUFKZDYYNOTN-UHFFFAOYSA-M 0.000 claims 3
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 claims 3
- 239000008366 buffered solution Substances 0.000 claims 3
- 239000012930 cell culture fluid Substances 0.000 claims 3
- 229910000029 sodium carbonate Inorganic materials 0.000 claims 3
- 239000002609 medium Substances 0.000 claims 2
- 102000004169 proteins and genes Human genes 0.000 claims 2
- 108090000623 proteins and genes Proteins 0.000 claims 2
- 230000001225 therapeutic effect Effects 0.000 claims 2
- JKMHFZQWWAIEOD-UHFFFAOYSA-N 2-[4-(2-hydroxyethyl)piperazin-1-yl]ethanesulfonic acid Chemical compound OCC[NH+]1CCN(CCS([O-])(=O)=O)CC1 JKMHFZQWWAIEOD-UHFFFAOYSA-N 0.000 claims 1
- 102000004190 Enzymes Human genes 0.000 claims 1
- 108090000790 Enzymes Proteins 0.000 claims 1
- 239000007995 HEPES buffer Substances 0.000 claims 1
- 102000008394 Immunoglobulin Fragments Human genes 0.000 claims 1
- 108010021625 Immunoglobulin Fragments Proteins 0.000 claims 1
- UIIMBOGNXHQVGW-DEQYMQKBSA-M Sodium bicarbonate-14C Chemical compound [Na+].O[14C]([O-])=O UIIMBOGNXHQVGW-DEQYMQKBSA-M 0.000 claims 1
- 238000001816 cooling Methods 0.000 claims 1
- 108020001507 fusion proteins Proteins 0.000 claims 1
- 102000037865 fusion proteins Human genes 0.000 claims 1
- 238000005259 measurement Methods 0.000 claims 1
- ULWHHBHJGPPBCO-UHFFFAOYSA-N propane-1,1-diol Chemical compound CCC(O)O ULWHHBHJGPPBCO-UHFFFAOYSA-N 0.000 claims 1
- 159000000000 sodium salts Chemical class 0.000 claims 1
Classifications
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- A—HUMAN NECESSITIES
- A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
- A01N—PRESERVATION OF BODIES OF HUMANS OR ANIMALS OR PLANTS OR PARTS THEREOF; BIOCIDES, e.g. AS DISINFECTANTS, AS PESTICIDES OR AS HERBICIDES; PEST REPELLANTS OR ATTRACTANTS; PLANT GROWTH REGULATORS
- A01N1/00—Preservation of bodies of humans or animals, or parts thereof
- A01N1/02—Preservation of living parts
- A01N1/0205—Chemical aspects
- A01N1/021—Preservation or perfusion media, liquids, solids or gases used in the preservation of cells, tissue, organs or bodily fluids
- A01N1/0221—Freeze-process protecting agents, i.e. substances protecting cells from effects of the physical process, e.g. cryoprotectants, osmolarity regulators like oncotic agents
-
- A—HUMAN NECESSITIES
- A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
- A01N—PRESERVATION OF BODIES OF HUMANS OR ANIMALS OR PLANTS OR PARTS THEREOF; BIOCIDES, e.g. AS DISINFECTANTS, AS PESTICIDES OR AS HERBICIDES; PEST REPELLANTS OR ATTRACTANTS; PLANT GROWTH REGULATORS
- A01N1/00—Preservation of bodies of humans or animals, or parts thereof
- A01N1/02—Preservation of living parts
- A01N1/0278—Physical preservation processes
-
- A—HUMAN NECESSITIES
- A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
- A01N—PRESERVATION OF BODIES OF HUMANS OR ANIMALS OR PLANTS OR PARTS THEREOF; BIOCIDES, e.g. AS DISINFECTANTS, AS PESTICIDES OR AS HERBICIDES; PEST REPELLANTS OR ATTRACTANTS; PLANT GROWTH REGULATORS
- A01N1/00—Preservation of bodies of humans or animals, or parts thereof
- A01N1/02—Preservation of living parts
- A01N1/0278—Physical preservation processes
- A01N1/0284—Temperature processes, i.e. using a designated change in temperature over time
-
- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
- C12N5/00—Undifferentiated human, animal or plant cells, e.g. cell lines; Tissues; Cultivation or maintenance thereof; Culture media therefor
- C12N5/0018—Culture media for cell or tissue culture
-
- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
- C12N5/00—Undifferentiated human, animal or plant cells, e.g. cell lines; Tissues; Cultivation or maintenance thereof; Culture media therefor
- C12N5/06—Animal cells or tissues; Human cells or tissues
- C12N5/0602—Vertebrate cells
- C12N5/0681—Cells of the genital tract; Non-germinal cells from gonads
- C12N5/0682—Cells of the female genital tract, e.g. endometrium; Non-germinal cells from ovaries, e.g. ovarian follicle cells
-
- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
- C12N2510/00—Genetically modified cells
- C12N2510/02—Cells for production
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- Life Sciences & Earth Sciences (AREA)
- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Wood Science & Technology (AREA)
- Zoology (AREA)
- Biomedical Technology (AREA)
- Biotechnology (AREA)
- General Health & Medical Sciences (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Genetics & Genomics (AREA)
- Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- Dentistry (AREA)
- Environmental Sciences (AREA)
- Biochemistry (AREA)
- General Engineering & Computer Science (AREA)
- Microbiology (AREA)
- Cell Biology (AREA)
- Reproductive Health (AREA)
- Micro-Organisms Or Cultivation Processes Thereof (AREA)
- Fuel Cell (AREA)
- Preparation Of Compounds By Using Micro-Organisms (AREA)
- Apparatus Associated With Microorganisms And Enzymes (AREA)
- Agricultural Chemicals And Associated Chemicals (AREA)
Claims (15)
1. Postupak zamrzavanja CHO stanica (stanica jajnika kineskog hrčka) radi skladištenja, naznačen time, da uključuje zamrzavanje CHO stanica u mediju za zamrzavanje, pri čemu medij za zamrzavanje sadrži puferiranu otopinu i krioprotektivno sredstvo, i gdje je pH vrijednost medija za zamrzavanje prilagođena na pH vrijednost od 7,5 do 8,5 prije zamrzavanja.
2. Postupak prema patentnom zahtjevu 1, naznačen time, da je pH vrijednost medija za zamrzavanje podešena na
a) pH od 7,5 do 8,3; ili
b) pH od oko 7,5.
3. Postupak prema patentnom zahtjevu 2, naznačen time, da se stanice kombiniraju s medijem za zamrzavanje prije i/ili nakon prilagođavanja pH vrijednosti.
4. Postupak prema bilo kojem od patentnih zahtjeva 2-3, naznačen time, da nadalje obuhvaća korak mjerenja
a) početne pH vrijednosti medija za zamrzavanje koji sadrži stanice prije prilagođavanja pH vrijednosti medija za zamrzavanje; ili
b) prilagođene pH vrijednosti medija za zamrzavanje; ili
c) prilagođene pH vrijednosti medija za zamrzavanje, pri čemu, ako je izmjerena pH vrijednost medija za zamrzavanje ispod ciljne pH vrijednosti, ponavlja se korak prilagođavanja i korak mjerenja sve dok prilagođena pH vrijednost medija za zamrzavanje ne bude od 7,5 do 8,3.
5. Postupak prema patentnom zahtjevu 2 ili 4, naznačen time, da se pH vrijednost prilagođava dodavanjem
a) baze; ili
b) baze, pri čemu je baza odabrana iz skupine koja se sastoji od natrijevog karbonata, natrijevog bikarbonata, natrijeve soli HEPES, natrijevog hidroksida i kalijevog hidroksida.
6. Postupak prema patentnom zahtjevu 5, naznačen time, da se pH vrijednost medija za zamrzavanje prilagođava dodavanjem
a) baze u medij za zamrzavanje prema sljedećoj formuli Vbaza = Cbaza*Vp(pHt -pHi), pri čemu je Cbaza koeficijent specifičan za bazu, Vbaza je volumen baze koji se dodaje mediju za zamrzavanje, Vp je volumen medija za zamrzavanje, pHt je ciljna pH vrijednost, a pHi je početna pH vrijednost; ili
b) baze u medij za zamrzavanje prema sljedećoj formuli Vbaza = Cbaza*Vp(pHt − pHi), pri čemu je Cbaza koeficijent specifičan za bazu, Vbaza je volumen baze koji se dodaje mediju za zamrzavanje, Vp je volumen medija za zamrzavanje, pHt je ciljna pH vrijednost, a pHi je početna pH vrijednost, pri čemu se pH vrijednost medija za zamrzavanje prilagođava dodavanjem natrijevog karbonata u medij za zamrzavanje prema sljedećoj formuli VNa2CO3 = 0,0085Vp(pHt − pHi), pri čemu je VNa2CO3 volumen od 1M natrijevog karbonata koji se dodaje mediju za zamrzavanje, Vp je volumen medija za zamrzavanje, pHt je ciljna pH vrijednost, a pHi je početna pH vrijednost.
7. Postupak prema patentnom zahtjevu 6, naznačen time, da ciljna pH vrijednost iznosi od 7,5 do 8,5, od 7,5 do 8,3 ili 7,5.
8. Postupak prema bilo kojem od patentnih zahtjeva 1-7, naznačen time, da se CHO stanice nalaze u mediju koji ima pH vrijednost od 6,2 do 6,6 prije nego što se CHO stanice kombiniraju s medijem za zamrzavanje.
9. Postupak prema bilo kojem od patentnih zahtjeva 1-8, naznačen time, da krioprotektivno sredstvo predstavlja
a) DMSO, glicerol, propandiol, etilen glikol ili šećer; ili
b) DMSO ili glicerol, pri čemu se DMSO ili glicerol u mediju za zamrzavanje prije zamrzavanja nalazi u koncentraciji od 5% do 12,5% po volumenu; ili
c) DMSO ili glicerol, pri čemu se DMSO ili glicerol u mediju za zamrzavanje prije zamrzavanja stanica nalazi u koncentraciji od 5% do 10% po volumenu.
10. Postupak prema bilo kojem od patentnih zahtjeva 1-9, naznačen time, da medij za zamrzavanje koji sadrži CHO stanice, ima staničnu gustoću od 8% do 28% volumena pakiranih stanica (PCV) prije zamrzavanja.
11. Postupak prema bilo kojem od patentnih zahtjeva 1-10, naznačen time, da nadalje obuhvaća korak hlađenja fluida stanične kulture tijekom procesa sakupljanja i koncentracije stanica prije nego što se CHO stanice kombiniraju s
a) medijem za zamrzavanje; ili
b) medijem za zamrzavanje, pri čemu se fluid stanične kulture hladi na temperaturu od ili nešto ispod 20°C; ili
c) medijem za zamrzavanje, pri čemu se fluid stanične kulture hladi na temperaturu od ili nešto ispod 10°C.
12. Bazen CHO stanica za zamrzavanje CHO stanica, naznačen time, da sadrži puferiranu otopinu, krioprotektivno sredstvo, dok CHO stanice sadrže nukleinsku kiselinu koja kodira polipeptid, pri čemu medij ima pH vrijednost od 7,5 do 8,5 prije zamrzavanja stanica.
13. Banka stanica, naznačena time, da sadrži mnoštvo spremnika i svaki spremnik sadrži (a) medij za zamrzavanje koji sadrži puferiranu otopinu i krioprotektivno sredstvo i (b) CHO stanice koje sadrže nukleinsku kiselinu koja kodira polipeptid, pri čemu medij za zamrzavanje ima pH vrijednost od 7,5 do 8,5 prije zamrzavanja stanice.
14. Banka stanica prema patentnom zahtjevu 13, naznačena time, da spremnici predstavljaju ampule.
15. Banka stanica prema patentnim zahtjevima 13 ili 14, naznačena time, da CHO stanice sadrže
a) nukleinske kiseline koja kodira polipeptid; ili
b) nukleinske kiseline koja kodira polipeptid, pri čemu je poželjno da polipeptid bude terapeutski protein, pri čemu je terapeutski protein odabran iz skupine koju čine protutijelo, fragment protutijela, enzim i fuzijski protein receptora.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201462022392P | 2014-07-09 | 2014-07-09 | |
| EP15750845.8A EP3166401B1 (en) | 2014-07-09 | 2015-07-09 | Ph adjustment to improve thaw recovery of cell banks |
| PCT/US2015/039757 WO2016007752A1 (en) | 2014-07-09 | 2015-07-09 | Ph adjustment to improve thaw recovery of cell banks |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20201663T1 true HRP20201663T1 (hr) | 2020-12-25 |
Family
ID=53872132
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20201663TT HRP20201663T1 (hr) | 2014-07-09 | 2020-10-14 | PRILAGOĐAVANJE pH VRIJEDNOSTI RADI POBOLJŠANJA OPORAVKA BANAKA STANICA USLIJED ODMRZAVANJA |
Country Status (19)
| Country | Link |
|---|---|
| US (2) | US10602739B2 (hr) |
| EP (2) | EP3777535A1 (hr) |
| JP (3) | JP6826975B2 (hr) |
| KR (1) | KR102355306B1 (hr) |
| CN (1) | CN106686977B (hr) |
| AU (1) | AU2015287760B2 (hr) |
| BR (1) | BR112017000142B1 (hr) |
| CA (1) | CA2953154C (hr) |
| ES (1) | ES2825574T3 (hr) |
| HR (1) | HRP20201663T1 (hr) |
| IL (1) | IL249659B (hr) |
| MX (1) | MX2017000231A (hr) |
| NZ (1) | NZ765734A (hr) |
| PL (1) | PL3166401T3 (hr) |
| RU (1) | RU2714759C2 (hr) |
| SG (1) | SG11201700097WA (hr) |
| SI (1) | SI3166401T1 (hr) |
| WO (1) | WO2016007752A1 (hr) |
| ZA (1) | ZA201700178B (hr) |
Families Citing this family (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106954623A (zh) * | 2016-01-11 | 2017-07-18 | 华北制药集团新药研究开发有限责任公司 | 一种哺乳动物悬浮细胞的冻存溶液及冻存方法 |
| CN106119186B (zh) * | 2016-06-24 | 2019-10-08 | 肇庆大华农生物药品有限公司 | 一种用于全悬浮培养mdck细胞的无血清培养基及其制备方法 |
| KR102236427B1 (ko) * | 2019-06-05 | 2021-04-06 | 연세대학교 산학협력단 | 오가노이드의 동결 보존용 조성물 |
| EP3795672A1 (en) * | 2019-09-18 | 2021-03-24 | Sartorius Stedim Biotech GmbH | System and method for the generation of high cell density seed culture |
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