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HRP20200589T1 - Redukcija ispiranja proteina a za vrijeme afinitetne kromatografije proteina a - Google Patents

Redukcija ispiranja proteina a za vrijeme afinitetne kromatografije proteina a Download PDF

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Publication number
HRP20200589T1
HRP20200589T1 HRP20200589TT HRP20200589T HRP20200589T1 HR P20200589 T1 HRP20200589 T1 HR P20200589T1 HR P20200589T T HRP20200589T T HR P20200589TT HR P20200589 T HRP20200589 T HR P20200589T HR P20200589 T1 HRP20200589 T1 HR P20200589T1
Authority
HR
Croatia
Prior art keywords
antibody
protein
hccf
preparation
chromatography
Prior art date
Application number
HRP20200589TT
Other languages
English (en)
Inventor
Robert L. Fahrner
Amy Laverdiere
Paul J. Mcdonald
Rhona M. O'leary
Original Assignee
Genentech, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=34193088&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=HRP20200589(T1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Genentech, Inc. filed Critical Genentech, Inc.
Publication of HRP20200589T1 publication Critical patent/HRP20200589T1/hr

Links

Classifications

    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/06—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies from serum
    • C07K16/065—Purification, fragmentation
    • 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
    • B01D15/38—Selective adsorption, e.g. chromatography characterised by the separation mechanism involving specific interaction not covered by one or more of groups B01D15/265 and B01D15/30 - B01D15/36, e.g. affinity, ligand exchange or chiral chromatography
    • B01D15/3804—Affinity chromatography
    • B01D15/3809—Affinity chromatography of the antigen-antibody type, e.g. protein A, G or L chromatography
    • 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
    • C07K1/14—Extraction; Separation; Purification
    • C07K1/16—Extraction; Separation; Purification by chromatography
    • C07K1/22—Affinity chromatography or related techniques based upon selective absorption processes
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/22—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against growth factors ; against growth regulators
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2839—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the integrin superfamily
    • C07K16/2845—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the integrin superfamily against integrin beta2-subunit-containing molecules, e.g. CD11, CD18
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/32—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against translation products of oncogenes
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/24—Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered

Landscapes

  • Chemical & Material Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Organic Chemistry (AREA)
  • Immunology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Molecular Biology (AREA)
  • Medicinal Chemistry (AREA)
  • Genetics & Genomics (AREA)
  • General Health & Medical Sciences (AREA)
  • Biophysics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biochemistry (AREA)
  • Analytical Chemistry (AREA)
  • Oncology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Peptides Or Proteins (AREA)
  • Enzymes And Modification Thereof (AREA)

Claims (13)

1. Postupak za redukciju ispiranja proteina A kod pročišćavanja antitijela koje sadrži regiju CH2/CH3 kromatografijom proteina A, naznačen time, da obuhvaća: razdvajanje rekombinantnih stanica domaćina koje eksprimiraju antitijelo od medija za staničnu kulturu kako bi se dobila prikupljena tekućina stanične kulture (HCCF, prema engl. harvested cell culture fluid) koja sadrži antitijelo i jednu ili više nečistoća; smanjivanje temperature pripravka HCCF koji se podvrgava kromatografiji proteina A na temperaturu u rasponu od 3°C do 18°C; i podvrgavanje pripravka HCCF koji je na temperaturi u rasponu od 3°C do 18°C kromatografiji proteina A kako bi se dobio pročišćeni pripravak antitijela; gdje smanjivanje temperature pripravka HCCF reducira ispiranje proteina A u pročišćenom pripravku antitijela tijekom kromatografije proteina A i antitijelo se odabire iz humaniziranog anti-HER2 antitijela trastuzumaba, humaniziranog 2C4 anti-HER2 antitijela, humaniziranog anti-CD11a antitijela, humaniziranog anti-VEGF antitijela ili Rituksimaba (kimernog anti-CD20 antitijela „C2B8“).
2. Postupak prema patentnom zahtjevu 1, naznačen time, da smanjivanje temperature pripravka HCCF koji se podvrgava kromatografiji proteina A i podvrgavanje pripravka HCCF kromatografiji proteina A smanjuje temperaturu pripravka HCCF na onu u rasponu od 10°C do 18°C.
3. Postupak prema patentnom zahtjevu 1 ili patentnom zahtjevu 2, naznačen time, da se rekombinantne stanice domaćina razdvajaju od medija za staničnu kulturu centrifugiranjem.
4. Postupak prema patentnom zahtjevu 1 ili patentnom zahtjevu 2, naznačen time, da se rekombinantne stanice domaćina razdvajaju od medija za staničnu kulturu tangencijalnom protočnom filtracijom.
5. Postupak prema bilo kojem od prethodnih patentnih zahtjeva, naznačen time, da nadalje obuhvaća dodavanje jednog ili više inhibitora proteaze u pripravak HCCF koji se podvrgava afinitetnoj kromatografiji proteina A kako bi se smanjila aktivnost proteaze.
6. Postupak prema bilo kojem od prethodnih patentnih zahtjeva, naznačen time, da nadalje obuhvaća snižavanje pH pripravka HCCF koji se podvrgava afinitetnoj kromatografiji proteina A.
7. Postupak prema patentnom zahtjevu 6, naznačen time, da se pH pripravka HCCF koji se podvrgava afinitetnoj kromatografiji proteina A snižava na pH u rasponu od oko 2,5 do oko 3,5.
8. Postupak prema bilo kojem patentnom zahtjevu 1-7, naznačen time, da antitijelo jest humanizirano anti-HER2 antitijelo trastuzumab.
9. Postupak prema bilo kojem patentnom zahtjevu 1-7, naznačen time, da antitijelo jest humanizirano 2C4 anti-HER2 antitijelo.
10. Postupak prema bilo kojem patentnom zahtjevu 1-7, naznačen time, da antitijelo jest humanizirano anti-CD11a antitijelo.
11. Postupak prema bilo kojem patentnom zahtjevu 1-7, naznačen time, da antitijelo jest humanizirano anti-VEGF antitijelo.
12. Postupak prema bilo kojem patentnom zahtjevu 1-7, naznačen time, da antitijelo jest Rituksimab (kimerno anti-CD20 antitijelo „C2B8“).
13. Postupak prema bilo kojem od prethodnih patentnih zahtjeva, naznačen time, da su stanice domaćina stanice CHO.
HRP20200589TT 2003-07-28 2020-04-14 Redukcija ispiranja proteina a za vrijeme afinitetne kromatografije proteina a HRP20200589T1 (hr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US49050003P 2003-07-28 2003-07-28
EP16164203.8A EP3095793B1 (en) 2003-07-28 2004-06-24 Reducing protein a leaching during protein a affinity chromatography

Publications (1)

Publication Number Publication Date
HRP20200589T1 true HRP20200589T1 (hr) 2020-07-10

Family

ID=34193088

Family Applications (1)

Application Number Title Priority Date Filing Date
HRP20200589TT HRP20200589T1 (hr) 2003-07-28 2020-04-14 Redukcija ispiranja proteina a za vrijeme afinitetne kromatografije proteina a

Country Status (14)

Country Link
US (2) US7485704B2 (hr)
EP (3) EP3722309A1 (hr)
JP (1) JP4599355B2 (hr)
AU (1) AU2004265253B2 (hr)
CA (1) CA2531595C (hr)
DK (2) DK3095793T3 (hr)
ES (1) ES2786568T3 (hr)
HR (1) HRP20200589T1 (hr)
HU (2) HUE029951T2 (hr)
LT (1) LT3095793T (hr)
PL (2) PL3095793T3 (hr)
PT (1) PT3095793T (hr)
SI (2) SI1648940T1 (hr)
WO (1) WO2005016968A2 (hr)

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