HRP20200372T1 - Postupci proizvodnje poloksamera za upotrebu u mediju za staničnu kulturu - Google Patents
Postupci proizvodnje poloksamera za upotrebu u mediju za staničnu kulturu Download PDFInfo
- Publication number
- HRP20200372T1 HRP20200372T1 HRP20200372TT HRP20200372T HRP20200372T1 HR P20200372 T1 HRP20200372 T1 HR P20200372T1 HR P20200372T T HRP20200372T T HR P20200372TT HR P20200372 T HRP20200372 T HR P20200372T HR P20200372 T1 HRP20200372 T1 HR P20200372T1
- Authority
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- Croatia
- Prior art keywords
- poloxamer
- minutes
- heated
- cell
- culture medium
- Prior art date
Links
- RVGRUAULSDPKGF-UHFFFAOYSA-N Poloxamer Chemical compound C1CO1.CC1CO1 RVGRUAULSDPKGF-UHFFFAOYSA-N 0.000 title claims 32
- 229920001983 poloxamer Polymers 0.000 title claims 31
- 229960000502 poloxamer Drugs 0.000 title claims 31
- 238000000034 method Methods 0.000 title claims 17
- 239000006143 cell culture medium Substances 0.000 title claims 8
- 230000003833 cell viability Effects 0.000 claims 6
- 210000004027 cell Anatomy 0.000 claims 4
- 239000007788 liquid Substances 0.000 claims 4
- 210000004978 chinese hamster ovary cell Anatomy 0.000 claims 2
- 238000001816 cooling Methods 0.000 claims 2
- 229920001577 copolymer Polymers 0.000 claims 2
- 229920001184 polypeptide Polymers 0.000 claims 2
- 102000004196 processed proteins & peptides Human genes 0.000 claims 2
- 108090000765 processed proteins & peptides Proteins 0.000 claims 2
- 239000007787 solid Substances 0.000 claims 2
- IAYPIBMASNFSPL-UHFFFAOYSA-N Ethylene oxide Chemical compound C1CO1 IAYPIBMASNFSPL-UHFFFAOYSA-N 0.000 claims 1
- 241000238631 Hexapoda Species 0.000 claims 1
- GOOHAUXETOMSMM-UHFFFAOYSA-N Propylene oxide Chemical compound CC1CO1 GOOHAUXETOMSMM-UHFFFAOYSA-N 0.000 claims 1
- 239000000427 antigen Substances 0.000 claims 1
- 102000036639 antigens Human genes 0.000 claims 1
- 108091007433 antigens Proteins 0.000 claims 1
- 238000004113 cell culture Methods 0.000 claims 1
- 239000012634 fragment Substances 0.000 claims 1
- 238000010438 heat treatment Methods 0.000 claims 1
- 210000004962 mammalian cell Anatomy 0.000 claims 1
- 238000002844 melting Methods 0.000 claims 1
- 230000008018 melting Effects 0.000 claims 1
- 238000003801 milling Methods 0.000 claims 1
- 229920001993 poloxamer 188 Polymers 0.000 claims 1
- 229940044519 poloxamer 188 Drugs 0.000 claims 1
- 230000035899 viability Effects 0.000 claims 1
Classifications
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- C—CHEMISTRY; METALLURGY
- C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
- C08G—MACROMOLECULAR COMPOUNDS OBTAINED OTHERWISE THAN BY REACTIONS ONLY INVOLVING UNSATURATED CARBON-TO-CARBON BONDS
- C08G65/00—Macromolecular compounds obtained by reactions forming an ether link in the main chain of the macromolecule
- C08G65/02—Macromolecular compounds obtained by reactions forming an ether link in the main chain of the macromolecule from cyclic ethers by opening of the heterocyclic ring
- C08G65/30—Post-polymerisation treatment, e.g. recovery, purification, drying
-
- 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
- C07K1/02—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length in solution
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
-
- C—CHEMISTRY; METALLURGY
- C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
- C08G—MACROMOLECULAR COMPOUNDS OBTAINED OTHERWISE THAN BY REACTIONS ONLY INVOLVING UNSATURATED CARBON-TO-CARBON BONDS
- C08G65/00—Macromolecular compounds obtained by reactions forming an ether link in the main chain of the macromolecule
- C08G65/34—Macromolecular compounds obtained by reactions forming an ether link in the main chain of the macromolecule from hydroxy compounds or their metallic derivatives
-
- C—CHEMISTRY; METALLURGY
- C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
- C08G—MACROMOLECULAR COMPOUNDS OBTAINED OTHERWISE THAN BY REACTIONS ONLY INVOLVING UNSATURATED CARBON-TO-CARBON BONDS
- C08G65/00—Macromolecular compounds obtained by reactions forming an ether link in the main chain of the macromolecule
- C08G65/34—Macromolecular compounds obtained by reactions forming an ether link in the main chain of the macromolecule from hydroxy compounds or their metallic derivatives
- C08G65/48—Polymers modified by chemical after-treatment
-
- 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
-
- 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
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/10—Immunoglobulins specific features characterized by their source of isolation or production
- C07K2317/14—Specific host cells or culture conditions, e.g. components, pH or temperature
-
- C—CHEMISTRY; METALLURGY
- C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
- C08G—MACROMOLECULAR COMPOUNDS OBTAINED OTHERWISE THAN BY REACTIONS ONLY INVOLVING UNSATURATED CARBON-TO-CARBON BONDS
- C08G2650/00—Macromolecular compounds obtained by reactions forming an ether link in the main chain of the macromolecule
- C08G2650/28—Macromolecular compounds obtained by reactions forming an ether link in the main chain of the macromolecule characterised by the polymer type
- C08G2650/50—Macromolecular compounds obtained by reactions forming an ether link in the main chain of the macromolecule characterised by the polymer type containing nitrogen, e.g. polyetheramines or Jeffamines(r)
-
- C—CHEMISTRY; METALLURGY
- C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
- C08G—MACROMOLECULAR COMPOUNDS OBTAINED OTHERWISE THAN BY REACTIONS ONLY INVOLVING UNSATURATED CARBON-TO-CARBON BONDS
- C08G2650/00—Macromolecular compounds obtained by reactions forming an ether link in the main chain of the macromolecule
- C08G2650/28—Macromolecular compounds obtained by reactions forming an ether link in the main chain of the macromolecule characterised by the polymer type
- C08G2650/58—Ethylene oxide or propylene oxide copolymers, e.g. pluronics
-
- 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
- C12N2500/00—Specific components of cell culture medium
- C12N2500/50—Soluble polymers, e.g. polyethyleneglycol [PEG]
Claims (15)
1. Postupak proizvodnje poloksamera za upotrebu u mediju za staničnu kulturu, naznačen time, da obuhvaća sljedeće korake:
(a) zagrijavanje krutog poloksamera na najmanje 60 °C radi dobivanja tekućeg poloksamera; pri čemu
a1) se poloksamer zagrijava između 157 °C i 185 °C najmanje 1 minutu; ili
a2) poloksamer se zagrijava između 134 °C i 157 °C najmanje 30 minuta; ili
a3) poloksamer se zagrijava između 120 °C i 134 °C najmanje 62 minute; ili
a4) poloksamer se zagrijava između 100 °C i 120 °C najmanje 98 minuta; ili
a5) poloksamer se zagrijava između 80 °C i 100 °C najmanje 122 minute; ili
a6) poloksamer se zagrijava između 60 °C i 80 °C najmanje 143 minute; i
(b) hlađenje tekućeg poloksamera do temperature ispod 50 °C radi dobivanja krutog termički obrađenog poloksamera, gdje se hlađenje ne provodi u uređaju za uzrnjavanje ni za mljevenje, pri čemu poloksamer sadrži kopolimer etilenoksida i propilenoksida, dok je održivost stanica u mediju za staničnu kulturu koji sadrži termički obrađen poloksamer, povećana za najmanje 10 % u odnosu na održivost stanica u mediju za staničnu kulturu koji sadrži poloksamer prije koraka (a), pri čemu je održivost stanica u mediju za staničnu kulturu koji sadrži neobrađeni poloksamer ispod 80 %, te time, da se održivost stanica mjeri kao što je opisano u specifikaciji.
2. Postupak prema patentnom zahtjevu 1, naznačen time, da
a1) se poloksamer zagrijava između 157 °C i 185 °C između 1 minute i 250 minuta; ili
a2) poloksamer se zagrijava između 134 °C i 157 °C između 30 minuta i 250 minuta; ili
a3) poloksamer se zagrijava između 120 °C i 134 °C između 62 minute i 250 minuta; ili
a4) poloksamer se zagrijava između 100 °C i 120 °C između 98 minuta i 250 minuta; ili
a5) poloksamer se zagrijava između 80 °C i 100 °C između 122 minute i 250 minuta; ili
a6) poloksamer se zagrijava između 60 °C i 80 °C između 143 minute i 250 minuta.
3. Postupak prema patentnom zahtjevu 1, naznačen time, da se održivost stanica povećava za najmanje 20 %.
4. Postupak prema patentnom zahtjevu 1, naznačen time, da se održivost stanica povećava za najmanje 30 %.
5. Postupak prema bilo kojem od patentnih zahtjeva 1-4, naznačen time, da se održivost stanica u mediju za staničnu kulturu koji sadrži poloksamer prije koraka (a), nalazi ispod 80 % nakon 3 sata kultivacije stanica.
6. Postupak prema bilo kojem od patentnih zahtjeva1-5, naznačen time, da se tekući poloksamer u koraku (b) hladi na sobnoj temperaturi, na temperaturi od 2 °C do 8 °C ili ispod 0 °C.
7. Postupak prema bilo kojem od patentnih zahtjeva 1-6, naznačen time, da se poloksamer zagrijava pod vakuumom.
8. Postupak prema bilo kojem od patentnih zahtjeva 1-7, naznačen time, da se tekući poloksamer hladi najmanje 20 minuta.
9. Postupak prema bilo kojem od patentnih zahtjeva 1-8, naznačen time, da se termički obrađeni poloksamer proizveden u koraku (b), dodaje u medij za staničnu kulturu.
10. Postupak prema bilo kojem od patentnih zahtjeva 1-9, naznačen time, da se koraci (a) i (b) ponavljaju barem jednom prije dodavanja termički obrađenog poloksamera u medij za staničnu kulturu.
11. Postupak prema bilo kojem od patentnih zahtjeva 1-10, naznačen time, da je poloksamer tretiran postupkom uzrnjavanja prije koraka (a).
12. Postupak prema bilo kojem od patentnih zahtjeva 1-11, naznačen time, da poloksamer
a) ima formulu HO(C2H4O)n(C3H6O)m(C2H4O)nH, pri čemu je n od 60 do 150, a m je od 25 do 60; i/ili
b) ima temperaturu taljenja od oko 55 °C; i/ili
c) ima prosječnu molekulsku masu od 6.000 do 18.000 Daltona; i/ili
d) sadrži kopolimer koji ima formulu HO(C2H4O)n(C3H6O)m(C2H4O)nH gdje n ima vrijednost od 80, a m ima vrijednost od 27, dok poloksamer ima prosječnu molekulsku masu od 7.680 do 9.510 g/mol; i/ili
e) je poloksamer 188.
13. Postupak prema bilo kojem od patentnih zahtjeva 1-12, naznačen time, da je stanica
a) stanica sisavaca; i/ili
b) stanica jajnika kineskog hrčka (CHO); i/ili
c) stanica insekta.
14. Postupak prema bilo kojem od patentnih zahtjeva 1-13, naznačen time, da stanica proizvodi polipeptid.
15. Postupak prema patentnom zahtjevu 14, naznačen time, da je polipeptid protutijelo ili njegov vezni fragment antigena.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201461970281P | 2014-03-25 | 2014-03-25 | |
| EP15715932.8A EP3122799B8 (en) | 2014-03-25 | 2015-03-25 | Methods of preparing a poloxamer for use in cell culture medium |
| PCT/US2015/022592 WO2015148736A1 (en) | 2014-03-25 | 2015-03-25 | Methods of preparing a poloxamer for use in cell culture medium |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20200372T1 true HRP20200372T1 (hr) | 2020-06-12 |
Family
ID=52824596
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20200372TT HRP20200372T1 (hr) | 2014-03-25 | 2020-03-04 | Postupci proizvodnje poloksamera za upotrebu u mediju za staničnu kulturu |
Country Status (19)
| Country | Link |
|---|---|
| US (2) | US11034793B2 (hr) |
| EP (2) | EP3122799B8 (hr) |
| JP (3) | JP6655548B2 (hr) |
| KR (1) | KR102352250B1 (hr) |
| CN (2) | CN111808276A (hr) |
| AU (1) | AU2015236008B2 (hr) |
| BR (1) | BR112016021739B1 (hr) |
| CA (1) | CA2943357C (hr) |
| ES (1) | ES2778680T3 (hr) |
| HR (1) | HRP20200372T1 (hr) |
| IL (2) | IL247902B (hr) |
| MX (2) | MX2016012288A (hr) |
| MY (1) | MY178060A (hr) |
| PL (1) | PL3122799T3 (hr) |
| RU (1) | RU2710551C2 (hr) |
| SG (1) | SG11201607929PA (hr) |
| SI (1) | SI3122799T1 (hr) |
| WO (1) | WO2015148736A1 (hr) |
| ZA (1) | ZA201606711B (hr) |
Families Citing this family (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP6655548B2 (ja) | 2014-03-25 | 2020-02-26 | ジェネンテック， インコーポレイテッド | 細胞培養培地における使用のためのポロキサマーを調製する方法 |
| JP7037495B2 (ja) * | 2016-03-17 | 2022-03-16 | メルク パテント ゲゼルシャフト ミット ベシュレンクテル ハフツング | ポロキサマーを精製するための方法 |
| US11891510B2 (en) | 2017-12-21 | 2024-02-06 | Sigma-Aldrich Co. Llc | Poloxamer compositions and methods of making and using same |
| RU2741710C1 (ru) * | 2018-07-12 | 2021-01-28 | Елена Валентиновна Аршинцева | Термический способ стерилизации жидких лекарственных средств, содержащих в своем составе полоксамер |
| WO2020022511A1 (ja) * | 2018-07-27 | 2020-01-30 | 味の素株式会社 | 動物細胞の浮遊培養用の添加物、浮遊培養用培地および浮遊培養方法 |
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2015
- 2015-03-25 JP JP2016558605A patent/JP6655548B2/ja active Active
- 2015-03-25 MX MX2016012288A patent/MX2016012288A/es unknown
- 2015-03-25 KR KR1020167029244A patent/KR102352250B1/ko active IP Right Grant
- 2015-03-25 SG SG11201607929PA patent/SG11201607929PA/en unknown
- 2015-03-25 AU AU2015236008A patent/AU2015236008B2/en active Active
- 2015-03-25 MY MYPI2016001715A patent/MY178060A/en unknown
- 2015-03-25 EP EP15715932.8A patent/EP3122799B8/en active Active
- 2015-03-25 PL PL15715932T patent/PL3122799T3/pl unknown
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