AU2013384204B2 - Low acidic species compositions and methods for producing and using the same - Google Patents

Low acidic species compositions and methods for producing and using the same Download PDF

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Publication number
AU2013384204B2
AU2013384204B2 AU2013384204A AU2013384204A AU2013384204B2 AU 2013384204 B2 AU2013384204 B2 AU 2013384204B2 AU 2013384204 A AU2013384204 A AU 2013384204A AU 2013384204 A AU2013384204 A AU 2013384204A AU 2013384204 B2 AU2013384204 B2 AU 2013384204B2
Authority
AU
Australia
Prior art keywords
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adalimumab
composition
pharmaceutical composition
acidic species
Prior art date
Legal status (The legal status 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 status listed.)
Withdrawn - After Issue
Application number
AU2013384204A
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English (en)
Other versions
AU2013384204A1 (en
Inventor
Christopher Chumsae
Diane D. Dong
Kathreen A. Gifford
Matthew Omon HERIGSTAD
Zehra Kaymakcalan
Wen Chung Lim
Natarajan Ramasubramanyan
Kartik Subramanian
Hong Yang
Lihua Yang
Xiaobei ZENG
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
AbbVie Inc
Original Assignee
AbbVie 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
Priority claimed from PCT/US2013/031485 external-priority patent/WO2013158275A1/fr
Priority claimed from PCT/US2013/031681 external-priority patent/WO2013158279A1/fr
Application filed by AbbVie Inc filed Critical AbbVie Inc
Publication of AU2013384204A1 publication Critical patent/AU2013384204A1/en
Application granted granted Critical
Publication of AU2013384204B2 publication Critical patent/AU2013384204B2/en
Withdrawn - After Issue legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • 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
    • C07K16/24—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
    • C07K16/241—Tumor Necrosis Factors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • 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
    • C07K1/165—Extraction; Separation; Purification by chromatography mixed-mode 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
    • C07K1/18—Ion-exchange 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
AU2013384204A 2013-03-14 2013-10-18 Low acidic species compositions and methods for producing and using the same Withdrawn - After Issue AU2013384204B2 (en)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
PCT/US2013/031485 WO2013158275A1 (fr) 2012-04-20 2013-03-14 Procédés de culture cellulaire pour réduire des espèces acides
AUPCT/US2013/031485 2013-03-14
PCT/US2013/031681 WO2013158279A1 (fr) 2012-04-20 2013-03-14 Procédés de purification de protéines pour réduire des espèces acides
AUPCT/US2013/031681 2013-03-14
PCT/US2013/065749 WO2014158231A1 (fr) 2013-03-14 2013-10-18 Compositions d'espèces faiblement acides et leurs procédés de production et d'utilisation

Publications (2)

Publication Number Publication Date
AU2013384204A1 AU2013384204A1 (en) 2015-06-04
AU2013384204B2 true AU2013384204B2 (en) 2017-03-16

Family

ID=49517725

Family Applications (1)

Application Number Title Priority Date Filing Date
AU2013384204A Withdrawn - After Issue AU2013384204B2 (en) 2013-03-14 2013-10-18 Low acidic species compositions and methods for producing and using the same

Country Status (8)

Country Link
EP (1) EP2836515A1 (fr)
KR (1) KR20150129033A (fr)
AU (1) AU2013384204B2 (fr)
BR (1) BR112015017307A2 (fr)
CA (3) CA2926301A1 (fr)
HK (1) HK1206755A1 (fr)
SG (1) SG11201504260UA (fr)
WO (1) WO2014158231A1 (fr)

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WO2013158279A1 (fr) 2012-04-20 2013-10-24 Abbvie Inc. Procédés de purification de protéines pour réduire des espèces acides
US9067990B2 (en) 2013-03-14 2015-06-30 Abbvie, Inc. Protein purification using displacement chromatography
US9505833B2 (en) 2012-04-20 2016-11-29 Abbvie Inc. Human antibodies that bind human TNF-alpha and methods of preparing the same
US9181572B2 (en) 2012-04-20 2015-11-10 Abbvie, Inc. Methods to modulate lysine variant distribution
US9512214B2 (en) 2012-09-02 2016-12-06 Abbvie, Inc. Methods to control protein heterogeneity
US9017687B1 (en) 2013-10-18 2015-04-28 Abbvie, Inc. Low acidic species compositions and methods for producing and using the same using displacement chromatography
US9499614B2 (en) 2013-03-14 2016-11-22 Abbvie Inc. Methods for modulating protein glycosylation profiles of recombinant protein therapeutics using monosaccharides and oligosaccharides
WO2015051293A2 (fr) 2013-10-04 2015-04-09 Abbvie, Inc. Utilisation d'ions métalliques pour moduler les profils de glycosylation des protéines dans le cas de protéines recombinées
AU2014337263B2 (en) 2013-10-16 2019-12-12 Outlook Therapeutics, Inc. Buffer formulations for enhanced antibody stability
US9085618B2 (en) 2013-10-18 2015-07-21 Abbvie, Inc. Low acidic species compositions and methods for producing and using the same
US9181337B2 (en) 2013-10-18 2015-11-10 Abbvie, Inc. Modulated lysine variant species compositions and methods for producing and using the same
WO2015073884A2 (fr) 2013-11-15 2015-05-21 Abbvie, Inc. Compositions de protéines de liaison génétiquement glycomodifiées
US20160039924A1 (en) * 2014-08-05 2016-02-11 Abbvie Inc. Methods for modulating the glycosylation profile of recombinant proteins using dissolved oxygen
US10696735B2 (en) 2015-01-21 2020-06-30 Outlook Therapeutics, Inc. Modulation of charge variants in a monoclonal antibody composition
EP4056590A1 (fr) * 2015-08-24 2022-09-14 GlaxoSmithKline Intellectual Property (No.2) Limited Compositions biopharmaceutiques
JP7084308B2 (ja) 2016-02-03 2022-06-14 アウトルック セラピューティクス，インコーポレイティド 抗体安定性を増大させるための緩衝液製剤
GB201602938D0 (en) * 2016-02-19 2016-04-06 Ucb Biopharma Sprl Protein purification
WO2018027195A1 (fr) * 2016-08-05 2018-02-08 Abbvie Biotherapeutics Inc. Compositions contenant des quantités réduites d'isoformes acides de daclizumab et procédés de préparation associés
KR102511050B1 (ko) 2016-08-16 2023-03-17 리제너론 파아마슈티컬스, 인크. 혼합물로부터 개별 항체들을 정량하는 방법
CA3036965A1 (fr) 2016-09-16 2018-03-22 Leukocare Ag Nouveau procede de stabilisation d'un produit medicamenteux biopharmaceutique pendant le traitement
PL3532838T3 (pl) 2016-10-25 2022-10-03 Regeneron Pharmaceuticals, Inc. Metody i systemy analizy danych chromatograficznych
EP3339444A1 (fr) * 2016-12-20 2018-06-27 Mabxience Research, S.L. Procédé permettant d'obtenir une glycoprotéine ayant un pourcentage élevé de glycanes afucosylés
GB201711481D0 (en) 2017-07-17 2017-08-30 Ucb Biopharma Sprl Protein purification
TW202005694A (zh) 2018-07-02 2020-02-01 美商里珍納龍藥品有限公司 自混合物製備多肽之系統及方法
CN111693711B (zh) * 2019-03-12 2023-05-05 上海市质量监督检验技术研究院 一种超高压液相色谱串联质谱同时检测鲜蛋中103种抗生素残留的方法
MX2022007464A (es) * 2019-12-18 2022-06-27 Tesaro Inc Composiciones biofarmaceuticas y metodos relacionados.
WO2022154762A1 (fr) * 2021-01-18 2022-07-21 Turgut İlaçlari A.Ş. Procédé de production d'adalimumab

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Also Published As

Publication number Publication date
HK1206755A1 (en) 2016-01-15
CA2926384A1 (fr) 2014-10-02
CA2899308A1 (fr) 2014-10-02
CA2899308C (fr) 2017-04-18
CA2926301A1 (fr) 2014-10-02
KR20150129033A (ko) 2015-11-18
SG11201504260UA (en) 2015-10-29
EP2836515A1 (fr) 2015-02-18
AU2013384204A1 (en) 2015-06-04
WO2014158231A1 (fr) 2014-10-02
BR112015017307A2 (pt) 2017-11-21

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