PE20231507A1 - Metodos para reducir el contenido de proteinas de la celula huesped en procesos de purificacion de anticuerpos y composiciones de anticuerpos que tienen un contenido reducido de proteinas de la celula huesped - Google Patents

Metodos para reducir el contenido de proteinas de la celula huesped en procesos de purificacion de anticuerpos y composiciones de anticuerpos que tienen un contenido reducido de proteinas de la celula huesped

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Publication number
PE20231507A1
PE20231507A1 PE2023001345A PE2023001345A PE20231507A1 PE 20231507 A1 PE20231507 A1 PE 20231507A1 PE 2023001345 A PE2023001345 A PE 2023001345A PE 2023001345 A PE2023001345 A PE 2023001345A PE 20231507 A1 PE20231507 A1 PE 20231507A1
Authority
PE
Peru
Prior art keywords
host cell
antibody
protein
seq
n3pglu
Prior art date
Application number
PE2023001345A
Other languages
English (en)
Inventor
Lihua Huang
Steven A Plichta
Sarah M Richer
Brian David Bowes
Lara Ellen Krebs
Original Assignee
Lilly Co Eli
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
Application filed by Lilly Co Eli filed Critical Lilly Co Eli
Publication of PE20231507A1 publication Critical patent/PE20231507A1/es

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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
    • C07K1/16Extraction; Separation; Purification by chromatography
    • C07K1/22Affinity chromatography or related techniques based upon selective absorption processes
    • 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
    • C07K1/34Extraction; Separation; Purification by filtration, ultrafiltration or reverse osmosis
    • 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
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/06Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies from serum
    • C07K16/065Purification, fragmentation
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/08Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from viruses
    • C07K16/10Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from viruses from RNA viruses
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/08Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from viruses
    • C07K16/10Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from viruses from RNA viruses
    • C07K16/1002Coronaviridae
    • C07K16/1003Severe acute respiratory syndrome coronavirus 2 [SARS‐CoV‐2 or Covid-19]
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/505Medicinal preparations containing antigens or antibodies comprising antibodies
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/10Immunoglobulins specific features characterized by their source of isolation or production
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/10Immunoglobulins specific features characterized by their source of isolation or production
    • C07K2317/14Specific host cells or culture conditions, e.g. components, pH or temperature
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/20Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/21Immunoglobulins specific features characterized by taxonomic origin from primates, e.g. man
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/30Immunoglobulins specific features characterized by aspects of specificity or valency
    • C07K2317/31Immunoglobulins specific features characterized by aspects of specificity or valency multispecific
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/70Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/76Antagonist effect on antigen, e.g. neutralization or inhibition of binding

Landscapes

  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • General Health & Medical Sciences (AREA)
  • Genetics & Genomics (AREA)
  • Medicinal Chemistry (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
  • Analytical Chemistry (AREA)
  • Immunology (AREA)
  • Virology (AREA)
  • Engineering & Computer Science (AREA)
  • Water Supply & Treatment (AREA)
  • Pulmonology (AREA)
  • Peptides Or Proteins (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)

Abstract

Referida a una composicion farmaceutica que comprende un anticuerpo que se une a N3pGlu A? humano (anticuerpo anti-N3pGlu A?), en donde el anticuerpo anti-N3pGlu A? se preparo mediante un proceso que comprende purificar el anticuerpo anti-N3pGlu a partir de una celula huesped de mamifero, y en donde el contenido total de proteinas de la celula huesped (HCP) en la composicion es menos de aproximadamente 100 ppm (medido por LCMS) y la composicion comprende una de, combinaciones de, o todas las siguientes proteinas de la celula huesped: proteina S100-A6, proteina S100-A11, proteina 2 similar a la fosfolipasa B, proteina protectora lisosomal, proteina ribosomal S27a de 40S-ubiquitina, calicreina-11, isoforma X1 de la serina proteasa HTRA1, subcomponente C1r del complemento, actina, isoforma X1 del musculo liso aortico, proteina cognada de choque termico de 71 kDa y peroxirredoxina-1. El anticuerpo antiN3pGlu A? comprende una cadena pesada (HC) y una cadena ligera (LC), en donde la cadena ligera comprende una region variable de la cadena ligera (LCVR) y la cadena pesada comprende una region variable de la cadena pesada (HCVR), en donde la LCVR comprende las secuencias de aminoacidos LCDR1, LCDR2 y LCDR3, y la HCVR comprende las secuencias de aminoacidos HCDR1, HCDR2 y HCDR3, en donde LCDR1 es KSSQSLLYSRGKTYLN (SEQ ID NO:17), LCDR2 es AVSKLDS (SEQ ID NO:18), LCDR3 es VQGTHYPFT (SEQ ID NO:19), HCDR1 es GYDFTRYYIN (SEQ ID NO:20), HCDR2 es WINPGSGNTKYNEKFKG (SEQ ID NO:21) y HCDR3 es EGITVY (SEQ ID NO:22). Tambien esta referida a metodos para reducir el contenido de proteinas de la celula huesped en una preparacion de anticuerpo producido de forma recombinante en una celula huesped en el proceso de fabricacion de anticuerpos.
PE2023001345A 2020-10-02 2021-10-04 Metodos para reducir el contenido de proteinas de la celula huesped en procesos de purificacion de anticuerpos y composiciones de anticuerpos que tienen un contenido reducido de proteinas de la celula huesped PE20231507A1 (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US202063086915P 2020-10-02 2020-10-02
PCT/US2021/053407 WO2022072934A1 (en) 2020-10-02 2021-10-04 Methods for reducing host cell protein content in antibody purification processes and antibody compositions having reduced host cell protein content

Publications (1)

Publication Number Publication Date
PE20231507A1 true PE20231507A1 (es) 2023-09-26

Family

ID=78621988

Family Applications (1)

Application Number Title Priority Date Filing Date
PE2023001345A PE20231507A1 (es) 2020-10-02 2021-10-04 Metodos para reducir el contenido de proteinas de la celula huesped en procesos de purificacion de anticuerpos y composiciones de anticuerpos que tienen un contenido reducido de proteinas de la celula huesped

Country Status (17)

Country Link
US (2) US20230374063A1 (es)
EP (2) EP4222159A1 (es)
JP (2) JP2023545019A (es)
KR (2) KR20230061462A (es)
CN (2) CN116547292A (es)
AR (1) AR123688A1 (es)
AU (2) AU2021355521A1 (es)
BR (1) BR112023004871A2 (es)
CA (2) CA3193722A1 (es)
CL (1) CL2023000961A1 (es)
CO (1) CO2023004265A2 (es)
EC (1) ECSP23024034A (es)
IL (2) IL301584A (es)
MX (2) MX2023003863A (es)
PE (1) PE20231507A1 (es)
TW (1) TW202229307A (es)
WO (2) WO2022072919A1 (es)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2024068996A1 (en) 2022-09-30 2024-04-04 Centre Hospitalier Universitaire Vaudois (C.H.U.V.) Anti-sars-cov-2 antibodies and use thereof in the treatment of sars-cov-2 infection

Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
SG10201702922VA (en) * 2008-10-20 2017-06-29 Abbvie Inc Isolation and purification of antibodies using protein a affinity chromatography
ME02352B (me) 2010-08-12 2016-06-20 Lilly Co Eli PROTUTIJELA PROTIV N3pGiu-AMILOlDNOG BETA PEPTlDA l NJIHOVA UPOTREBA
WO2012136552A1 (en) * 2011-04-08 2012-10-11 H. Lundbeck A/S ANTIBODIES SPECIFIC TO PYROGLUTAMATED Αβ
WO2015175769A1 (en) * 2014-05-15 2015-11-19 Biogen Ma Inc. Methods for the detection of amyloid beta oligomers in biological samples
WO2018170488A1 (en) * 2017-03-17 2018-09-20 Gilead Sciences, Inc. Method of purifying an antibody
JOP20190247A1 (ar) 2017-04-20 2019-10-20 Lilly Co Eli أجسام بيتا ببتيد النشوانية المضادة لـ N3pGlu واستخداماتها
PE20221893A1 (es) * 2020-04-02 2022-12-13 Regeneron Pharma Anticuerpos contra glicoproteina de espicula anti-sars-cov-2 y fragmentos de union al antigeno

Also Published As

Publication number Publication date
EP4222159A1 (en) 2023-08-09
CL2023000961A1 (es) 2023-11-03
WO2022072934A1 (en) 2022-04-07
JP2023545019A (ja) 2023-10-26
BR112023004871A2 (pt) 2023-04-25
ECSP23024034A (es) 2023-04-28
CN116348486A (zh) 2023-06-27
AU2021355521A1 (en) 2023-05-11
AU2021355518A1 (en) 2023-06-08
CA3193722A1 (en) 2022-04-07
MX2023003863A (es) 2023-04-14
US20230406914A1 (en) 2023-12-21
CO2023004265A2 (es) 2023-04-27
AU2021355518A9 (en) 2024-02-08
KR20230061462A (ko) 2023-05-08
AR123688A1 (es) 2023-01-04
MX2023003836A (es) 2023-04-14
EP4222160A1 (en) 2023-08-09
CN116547292A (zh) 2023-08-04
KR20230078748A (ko) 2023-06-02
US20230374063A1 (en) 2023-11-23
JP2023544399A (ja) 2023-10-23
CA3192910A1 (en) 2022-04-07
IL301572A (en) 2023-05-01
IL301584A (en) 2023-05-01
TW202229307A (zh) 2022-08-01
WO2022072919A1 (en) 2022-04-07

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