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AR102198A1 - Proceso para reducir partículas subvisibles en una formulación farmacéutica - Google Patents

Proceso para reducir partículas subvisibles en una formulación farmacéutica

Info

Publication number
AR102198A1
AR102198A1 ARP150103235A ARP150103235A AR102198A1 AR 102198 A1 AR102198 A1 AR 102198A1 AR P150103235 A ARP150103235 A AR P150103235A AR P150103235 A ARP150103235 A AR P150103235A AR 102198 A1 AR102198 A1 AR 102198A1
Authority
AR
Argentina
Prior art keywords
protein
subvisible particles
fatty acid
acid ester
composition
Prior art date
Application number
ARP150103235A
Other languages
English (en)
Original Assignee
Regeneron Pharma
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 Regeneron Pharma filed Critical Regeneron Pharma
Publication of AR102198A1 publication Critical patent/AR102198A1/es

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39591—Stabilisation, fragmentation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • Engineering & Computer Science (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Immunology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Peptides Or Proteins (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)

Abstract

Reivindicación 1: Una composición que comprende (a) una proteína, (b) un éster de ácido graso intacto, y (c) (i) no más de 400 partículas subvisibles de 10 mm o más de diámetro, o (ii) no más de 10.000 partículas subvisibles de 2 mm o más de diámetro. Reivindicación 2: La composición de acuerdo con la reivindicación 1, en donde la proteína es un anticuerpo. Reivindicación 4: La composición de acuerdo con cualquiera de las reivindicaciones 1 - 3, en donde el éster de ácido graso es un mono o di-éster de ácido graso de polioxietilén sorbitán o isosorbida. Reivindicación 15: Un proceso para elaborar una formulación de proteína estable que comprende la etapa de llenar un recipiente con una sustancia farmacológica formulada, que está esencialmente libre de actividad de esterasa y que contiene una proteína y un éster de ácido graso, en donde la sustancia farmacológica formulada está esencialmente libre de partículas subvisibles. Reivindicación 16: El proceso de acuerdo con la reivindicación 15, en donde la sustancia farmacológica formulada se obtiene poniendo en contacto una composición, que contiene la proteína y una esterasa, con un medio de interacción hidrofóbica, y recolectando la proteína.
ARP150103235A 2014-10-09 2015-10-07 Proceso para reducir partículas subvisibles en una formulación farmacéutica AR102198A1 (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US201462061797P 2014-10-09 2014-10-09

Publications (1)

Publication Number Publication Date
AR102198A1 true AR102198A1 (es) 2017-02-08

Family

ID=54364685

Family Applications (1)

Application Number Title Priority Date Filing Date
ARP150103235A AR102198A1 (es) 2014-10-09 2015-10-07 Proceso para reducir partículas subvisibles en una formulación farmacéutica

Country Status (4)

Country Link
US (5) US10342876B2 (es)
AR (1) AR102198A1 (es)
TW (1) TW201628649A (es)
WO (1) WO2016057739A1 (es)

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EP3826743A4 (en) 2018-07-25 2022-09-14 Merck Sharp & Dohme Corp. METHODS FOR SEPARATION OF HOST CELL LIPASES FROM A PRODUCTION PROTEIN IN CHROMATOGRAPHIC METHODS
KR20250099418A (ko) 2018-08-15 2025-07-01 브리스톨-마이어스 스큅 컴퍼니 하류 크로마토그래피에서의 재산화에 의한 단백질 단편화 제어 전략
KR20210090649A (ko) 2018-11-05 2021-07-20 브리스톨-마이어스 스큅 컴퍼니 Peg화 단백질의 정제 방법
US20220135619A1 (en) 2019-02-24 2022-05-05 Bristol-Myers Squibb Company Methods of isolating a protein
US12174161B2 (en) 2019-03-29 2024-12-24 Bristol-Myers Squibb Company Methods of measuring hydrophobicity of chromatographic resins
JP7539420B2 (ja) 2019-06-28 2024-08-23 武田薬品工業株式会社 アデノ随伴ウイルスの精製方法

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US12070502B2 (en) 2024-08-27
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