HRP20240222T1 - Postupci inaktivacije virusa korištenjem ekološki prihvatljivih deterdženata - Google Patents

Postupci inaktivacije virusa korištenjem ekološki prihvatljivih deterdženata Download PDF

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HRP20240222T1
HRP20240222T1 HRP20240222TT HRP20240222T HRP20240222T1 HR P20240222 T1 HRP20240222 T1 HR P20240222T1 HR P20240222T T HRP20240222T T HR P20240222TT HR P20240222 T HRP20240222 T HR P20240222T HR P20240222 T1 HRP20240222 T1 HR P20240222T1
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detergent
chromatography
variants
original flow
product
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HRP20240222TT
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Susan Fisher
Qi Chen
Lenore NORLING
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F. Hoffmann - La Roche Ag
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    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K1/00General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
    • C07K1/14Extraction; Separation; Purification
    • C07K1/36Extraction; Separation; Purification by a combination of two or more processes of different types
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12NMICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N7/00Viruses; Bacteriophages; Compositions thereof; Preparation or purification thereof
    • C12N7/04Inactivation or attenuation; Producing viral sub-units
    • C12N7/06Inactivation or attenuation by chemical treatment
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K1/00General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
    • C07K1/14Extraction; Separation; Purification
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/16Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using chemical substances
    • A61L2/18Liquid substances or solutions comprising solids or dissolved gases
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K1/00General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
    • C07K1/14Extraction; Separation; Purification
    • C07K1/16Extraction; Separation; Purification by chromatography
    • C07K1/18Ion-exchange chromatography
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K1/00General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
    • C07K1/14Extraction; Separation; Purification
    • C07K1/16Extraction; Separation; Purification by chromatography
    • C07K1/22Affinity chromatography or related techniques based upon selective absorption processes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/0005Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts
    • A61L2/0082Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts using chemical substances
    • A61L2/0088Liquid substances
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2202/00Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
    • A61L2202/20Targets to be treated
    • A61L2202/21Pharmaceuticals, e.g. medicaments, artificial body parts

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  • Chemical & Material Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Organic Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Genetics & Genomics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
  • Analytical Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Immunology (AREA)
  • Biomedical Technology (AREA)
  • Zoology (AREA)
  • Wood Science & Technology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Pharmacology & Pharmacy (AREA)
  • General Chemical & Material Sciences (AREA)
  • Microbiology (AREA)
  • Biotechnology (AREA)
  • Virology (AREA)
  • General Engineering & Computer Science (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Micro-Organisms Or Cultivation Processes Thereof (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Detergent Compositions (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)

Claims (26)

1. Postupak inaktivacije virusa u izvornom protoku proizvoda u procesu proizvodnje terapijskog polipeptida, naznačen time, da postupak uključuje korak izlaganja izvornog protoka deterdžentu, pri čemu je deterdžent ekološki kompatibilan, s time, da ekološki kompatibilan deterdžent ima CAS registarski broj CAS 58846-77-8, CAS 59122-55-3, CAS 64366-70-7, CAS 27252-75-1, CAS 132778-08-6, CAS 110615-47-9 ili CAS 68515-73-1.
2. Postupak prema patentnom zahtjevu 1, naznačen time, da je nakon odlaganja očekivana koncentracija deterdženta u okolišu (eng. Predicted Environmental Concentration, PEC) u prihvatnom vodnom tijelu kao rezultat uporabe deterdženta ispod očekivane koncentracije deterdženta bez učinka (engl. Predicted No-Effect Concentration, PNEC).
3. Postupak prema patentnom zahtjevu 1 ili 2, naznačen time, da se postupkom održava kvaliteta proizvoda terapijskog polipeptida u usporedbi s postupkom koji koristi Triton X-100 ili postupkom bez deterdženta.
4. Postupak prema patentnom zahtjevu 3, naznačen time, da kvaliteta proizvoda terapijskog polipeptida dovodi do najviše 5 % promjene u varijantama proizvoda u odnosu na ukupnu količinu polipeptida u izvornom protoku proizvoda.
5. Postupak prema patentnom zahtjevu 4, naznačen time, da varijante proizvoda a) ne povećavaju se za više od 5% od ukupne količine polipeptida u izvornom protoku proizvoda; i/ili b) su varijante veličine, varijante naboja, varijante oksidacije, varijante deamidacije, varijante glikacije ili varijante s promijenjenim glikanskim profilima; i/ili c) varijante su kisele i/ili bazične varijante proizvoda.
6. Postupak prema bilo kojem od patentnih zahtjeva 1 do 5, naznačen time, da izlaganje izvornog protoka deterdžentu ne a) povećava fragmentaciju polipeptida za više od oko 5%; i/ili b) povećava agregaciju u izvornom protoku za više od oko 5%; i/ili c) smanjuje prinos polipeptida u procesu proizvodnje za više od oko 5%.
7. Postupak prema bilo kojem od patentnih zahtjeva 1 do 6, naznačen time, da se deterdžent dodaje u izvorni protok do postizanja konačne koncentracije od a) oko 0,01% do oko 10%; i/ili b) oko 0,3% do oko 1%.
8. Postupak prema bilo kojem od patentnih zahtjeva od 1do 7, naznačen time, da se izvorni protok izlaže deterdžentu a) najmanje oko 1 minute do najmanje oko 48 sati, i/ili b) najmanje oko 15 minuta do najmanje oko 3 sata; i/ili c) najmanje oko 1 sat; i/ili d) na otprilike 4 °C do otprilike 30 °C; i/ili e) na otprilike 15 °C do otprilike 20 °C.
9. Postupak prema bilo kojem od patentnih zahtjeva 1 do 8, naznačen time, da deterdžent a) je neionski deterdžent ili cviterionski deterdžent; i/ili b) ima hidrofilno-lipofilni balans (HLB) od oko 12 do oko 15; i/ili c) ne sadrži niti formira oktilfenol; i/ili d) ne sadrži niti formira peroksid.
10. Postupak prema bilo kojem od patentnih zahtjeva 1 do 9, naznačen time, da a) izvorni protok sadrži deterdžent koji je niske zamućenosti; i/ili b) dodavanje deterdženta u izvorni protok ne povećava zamućenost izvornog protoka.
11. Postupak prema bilo kojem od patentnih zahtjeva 1 do 11, naznačen time, da deterdžent sadrži a) jedan ili više surfaktanata; i/ili b) jedan ili više surfaktanata, konzervansa, i kelatnih sredstava.
12. Postupak prema bilo kojem od patentnih zahtjeva 1 do 11, naznačen time, da izvorni protok sadrži a) fluid sakupljene stanične kulture, pri čemu se po mogućnosti deterdžent dodaje fluidu sakupljene stanične kulture; i/ili b) skup uzetih uzoraka ili skup dobivenog proizvoda.
13. Postupak prema patentnom zahtjevu 12, naznačen time, da skup uzetih uzoraka ili skup dobivenog proizvoda predstavlja a) skup afinitetne kromatografije; i/ili b) skup proteina A, skup proteina G ili skup proteina L.
14. Postupak prema patentnom zahtjevu 12, naznačen time, da skup uzetih uzoraka ili skup dobivenog proizvoda predstavlja a) skup kombinirane kromatografije; i/ili b) CaptoAdhere skup.
15. Postupak prema bilo kojem od patentnih zahtjeva 1 do 14, naznačen time, da se deterdžent koristi u kombinaciji sa sredstvom protiv pjenjenja, pri čemu je po mogućnosti sredstvo protiv pjenjenja simetikon.
16. Postupak prema bilo kojem od patentnih zahtjeva 1 do 15, naznačen time, da je virus a) virus s ovojnicom; i/ili b) retrovirus, herpesvirus, flavivirus, poksvirus, hepadnavirus, virus hepatitisa, ortomiksovirus, paramiksovirus, rabdovirus ili togavirus.
17. Postupak prema bilo kojem od patentnih zahtjeva 1 do 16, naznačen time, da je vrijednost logaritamske redukcije virusa (engl. log reduction value, LRV) deterdženta u izvornom protoku a) veća od otprilike jedan; i/ili b) veća od otprilike četiri.
18. Postupak prema patentnom zahtjevu 17, naznačen time, da se LRV izračunava na temelju testa infektivnosti, pri čemu je po mogućnosti test infektivnosti test plakova ili test TCID50.
19. Postupak prema bilo kojem od patentnih zahtjeva 1 do 18, naznačen time, da Postupak nadalje uključuje korak filtriranja izvornog protoka nakon dodavanja deterdženta.
20. Postupak prema patentnom zahtjevu 19, naznačen time, da je izvorni protok filtriran a) najmanje oko 15 minuta do najmanje oko 48 sati nakon dodavanja deterdženta; i/ili b) najmanje oko 1 sat do najmanje oko 3 sata nakon dodavanja deterdženta; i/ili c) otprilike 1 sat nakon dodavanja deterdženta.
21. Postupak prema patentnom zahtjevu 19 ili 20, naznačen time, da filter je ultrafilter ili dubinski filter.
22. Postupak prema bilo kojem od patentnih zahtjeva 1 do 21, naznačen time, da se izvorni protok podvrgava kromatografiji nakon dodavanja deterdženta.
23. Postupak prema patentnom zahtjevu 22, naznačen time, da je kromatografija jedna ili više od afinitetne kromatografije, kromatografije ionske izmjene, kromatografije hidrofobnih interakcija, kromatografije hidroksiapatita ili kombinirane kromatografije.
24. Postupak prema patentnom zahtjevu 23, naznačen time, da a) afinitetna kromatografija je kromatografija proteina A, kromatografija proteina G ili kromatografija proteina L; ili b) kromatografija ionske izmjene je kromatografija anionske izmjene ili kromatografija kationske izmjene; ili c) kombinirana kromatografija je CaptoAdhere kromatografija.
25. Postupak prema bilo kojem od patentnih zahtjeva 1 do 24, naznačen time, da terapijski polipeptid a) predstavlja protutijelo, imunoadhezin, enzim, faktor rasta, receptor, hormon, regulatorni faktor, citokin, Fc fuzijski polipeptid, antigen ili vezivno sredstvo; i/ili b) proizveden je u stanicama sisavaca, pri čemu je po mogućnosti stanična linija sisavaca stanica jajnika kineskog hrčka (CHO) ili stanica bubrega mladunčeta hrčka (BHK), stanica mišjeg hibridoma ili stanica mišjeg mijeloma.
26. Postupak prema patentnom zahtjevu 25, naznačen time, da je protutijelo monoklonsko protutijelo, kimerno protutijelo, humanizirano protutijelo, ljudsko protutijelo, bispecifično protutijelo ili fragment protutijela.
HRP20240222TT 2013-11-15 2014-11-13 Postupci inaktivacije virusa korištenjem ekološki prihvatljivih deterdženata HRP20240222T1 (hr)

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US201361905075P 2013-11-15 2013-11-15
US201461937284P 2014-02-07 2014-02-07
PCT/US2014/065391 WO2015073633A1 (en) 2013-11-15 2014-11-13 Methods for viral inactivation using eco-friendly detergents
EP14862284.8A EP3068417B1 (en) 2013-11-15 2014-11-13 Methods for viral inactivation using eco-friendly detergents

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HRP20240222T1 true HRP20240222T1 (hr) 2024-04-26

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US (1) US10611795B2 (hr)
EP (1) EP3068417B1 (hr)
JP (3) JP6993083B2 (hr)
KR (1) KR102238133B1 (hr)
CN (2) CN105722523B (hr)
CA (1) CA2930687C (hr)
HK (1) HK1225990A1 (hr)
HR (1) HRP20240222T1 (hr)
MX (1) MX2016006167A (hr)
PL (1) PL3068417T3 (hr)
RU (1) RU2707951C1 (hr)
WO (1) WO2015073633A1 (hr)

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