HRP20191409T1 - Postupci i sredstva za proizvodnju heterodimernih ig-sličnih molekula - Google Patents

Postupci i sredstva za proizvodnju heterodimernih ig-sličnih molekula Download PDF

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HRP20191409T1
HRP20191409T1 HRP20191409T HRP20191409T1 HR P20191409 T1 HRP20191409 T1 HR P20191409T1 HR P20191409 T HRP20191409 T HR P20191409T HR P20191409 T1 HRP20191409 T1 HR P20191409T1
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Kruif Cornelis Adriaan De
Linda Johanna Aleida Hendriks
Ton Logtenberg
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Merus Nv
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Claims (14)

1. Postupak za proizvodnju heterodimerne molekule koja sadrži CH3 domenu od jedne stanice, naznačenu time što navedena molekula sadrži dvije CH3 domene humanog IgG sposobne formirati sučelje, pri čemu navedeni postupak sadrži omogućavanje u navedenoj stanici a. prve molekule nukleinske kiseline koja kodira prvi polipeptidni lanac koji sadrži CH3 domenu humanog IgG, b. druge molekule nukleinske kiseline koja kodira drugi polipeptidni lanac koji sadrži CH3 domenu humanog IgG, pri čemu navedeni prvi polipeptidni lanac koji sadrži CH3 domenu sadrži ostatak lizina (K) na položaju amino-kiseline 366 u skladu s EU sustavom numeracije i pri čemu navedeni drugi polipeptidni lanac koji sadrži CH3 domenu sadrži ostatak asparaginske kiseline (D) na položaju amino-kiseline 351 u skladu s EU sustavom numeracije, navedeni postupak dalje sadrži korak kultivacije navedene stanice domaćina i dozvoljavanje ekspresije navedene dvije molekule nukleinske kiseline i sakupljanje navedene heterodimerne molekule koja sadrži CH3 domenu iz kulture.
2. Postupak u skladu s patentnim zahtjevom 1, koji dalje sadrži omogućavanje navedene stanice domaćina s molekulom nukleinske kiseline koja kodira zajednički laki lanac.
3. Postupak u skladu s patentnim zahtjevom 1 ili 2, naznačen time što navedeni prvi polipeptidni lanac koji sadrži CH3 domenu dalje sadrži ostatak lizina (K) na položaju amino-kiseline 351 u skladu s EU sustavom numeracije.
4. Postupak u skladu s patentnim zahtjevom 1 ili 2 ili 3, naznačen time što navedeni drugi polipeptidni lanac koji sadrži CH3 domenu dalje sadrži ostatak glutaminske kiseline (E) ili ostatak asparaginske kiseline (D) na položaju amino-kiseline 349 u skladu s EU sustavom numeracije, i/ili ostatak glutaminske kiseline (E) na položaju amino-kiseline 368 u skladu s EU sustavom numeracije.
5. Postupak u skladu s patentnim zahtjevom 4, naznačen time što navedeni drugi polipeptidni lanac koji sadrži CH3 domenu dalje sadrži ostatak glutaminske kiseline (E) na položaju amino-kiseline 368 u skladu s EU sustavom numeracije.
6. Postupak u skladu s bilo kojim od patentnih zahtjeva 1 do 5, naznačen time što je prisustvo kontaminirajućih homodimera manje od 5%, poželjno manje od 2%, poželjnije manje od 1%, i najpoželjnije kontaminirajući homodimeri su suštinski odsutni.
7. Postupak u skladu s bilo kojim od patentnih zahtjeva 1 do 6, naznačen time što svaki od polipeptidnih lanaca koji sadrže CH3 domenu dalje sadrži varijabilno područje koje prepoznaje ciljni epitop.
8. Postupak u skladu s patentnim zahtjevom 7, naznačen time što svako od dva varijabilna područja polipeptidnih lanaca koja sadrže CH3 domenu prepoznaje drugačiji ciljni epitop.
9. Heterodimerna molekula koja sadrži CH3 domenu koja se može dobiti postupcima u skladu s bilo kojim od patentnih zahtjeva 1-8.
10. Heterodimerno antitijelo koje sadrži dvije CH3 domene humanog IgG, naznačeno time što jedna od navedene dvije CH3 domene sadrži ostatak asparaginske kiseline (D) na položaju amino-kiseline 351 u skladu s EU sustavom numeracije i ostatak glutaminske kiseline (E) na položaju amino-kiseline 368 u skladu s EU sustavom numeracije i pri čemu druga od navedene dvije CH3 domene sadrži ostatak lizina (K) na položaju amino-kiseline 366 u skladu s EU sustavom numeracije i ostatak lizina (K) na položaju amino-kiseline 351 u skladu s EU sustavom numeracije.
11. Rekombinantna stanica domaćin koja sadrži sekvence nukleinske kiseline koje kodiraju najmanje prvi i drugi polipeptidni lanac koji sadrži CH3 domenu humanog IgG, naznačena time što navedeni prvi polipeptidni lanac koji sadrži CH3 domenu sadrži ostatak lizina (K) na položaju amino-kiseline 366 u skladu s EU sustavom numeracije i pri čemu navedeni drugi polipeptidni lanac koji sadrži CH3 domenu sadrži ostatak asparaginske kiseline (D) na položaju amino-kiseline 351 u skladu s EU sustavom numeracije.
12. Farmaceutski spoj koji sadrži heterodimernu molekulu koja sadrži CH3 domenu u skladu s patentnim zahtjevom 9 ili heterodimerno antitijelo u skladu s patentnim zahtjevom 10, i farmaceutski prihvatljiv nosač.
13. Postupak za stvaranje stanice domaćina za proizvodnju heterodimerne molekule koja sadrži CH3 domenu, naznačen time što postupak sadrži korak uvođenja u navedenu stanicu domaćina sekvenci nukleinske kiseline koje kodiraju najmanje prvi i drugi polipeptidni lanac koji sadrži CH3 domenu humanog IgG, pri čemu navedeni prvi polipeptidni lanac koji sadrži CH3 domenu sadrži ostatak lizina (K) na položaju amino-kiseline 366 u skladu s EU sustavom numeracije i pri čemu navedeni drugi polipeptidni lanac koji sadrži CH3 domenu sadrži ostatak asparaginske kiseline (D) na položaju amino-kiseline 351 u skladu s EU sustavom numeracije, pri čemu su navedene sekvence nukleinske kiseline uvedene uzastopno ili istovremeno.
14. Rekombinantne c stanice domaćina u skladu s patentnim zahtjevom 11, ili rekombinantne stanice domaćina dobivene postupkom u skladu s patentnim zahtjevom 13, koje proizvode heterodimernu molekulu koja sadrži CH3 domenu humanog IgG.
HRP20191409 2012-04-20 2019-08-02 Postupci i sredstva za proizvodnju heterodimernih ig-sličnih molekula HRP20191409T1 (hr)

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US201261635935P 2012-04-20 2012-04-20
EP13720615.7A EP2838918B1 (en) 2012-04-20 2013-04-19 Methods and means for the production of heterodimeric ig-like molecules
PCT/NL2013/050294 WO2013157954A1 (en) 2012-04-20 2013-04-19 Methods and means for the production of ig-like molecules

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