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AR089434A1 - Procedimiento para preparar formulaciones con alta concentracion de proteinas - Google Patents

Procedimiento para preparar formulaciones con alta concentracion de proteinas

Info

Publication number
AR089434A1
AR089434A1 ARP120104942A ARP120104942A AR089434A1 AR 089434 A1 AR089434 A1 AR 089434A1 AR P120104942 A ARP120104942 A AR P120104942A AR P120104942 A ARP120104942 A AR P120104942A AR 089434 A1 AR089434 A1 AR 089434A1
Authority
AR
Argentina
Prior art keywords
concentration
formulations
high concentration
protein formulations
proteins
Prior art date
Application number
ARP120104942A
Other languages
English (en)
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
Application filed by Genentech Inc filed Critical Genentech Inc
Publication of AR089434A1 publication Critical patent/AR089434A1/es

Links

Classifications

    • 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
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • 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
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/08—Solutions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • 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
    • C07K16/244—Interleukins [IL]
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/42—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against immunoglobulins
    • C07K16/4283—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against immunoglobulins against an allotypic or isotypic determinant on Ig
    • C07K16/4291—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against immunoglobulins against an allotypic or isotypic determinant on Ig against IgE
    • 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

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

Abstract

Proceso para preparar formulaciones proteicas líquidas de elevada concentración incluso bajo condiciones de elevada viscosidad que podrían tornar al proceso de filtrado tangencial de fluido (TFF) prohibitivo. Proceso para crear formulaciones de producto farmacológico de proteína que tienen una concentración de aproximadamente 50 - 700 mg/mI, y/o una viscosidad de por lo menos 40 cP. Proceso alternativo de fabricación mediante el cual las formulaciones de proteína (por ej, polipéptido o anticuerpo) se preparan usando un proceso de liofilización y reconstitución a granel (BLRP, por sus siglas en inglés). Proceso mejorado para preparar formulaciones proteicas líquidas, las cuales pueden ser almacenadas evitando el costo y la inconveniencia del congelamiento y el mantenimiento a -20ºC. Método alternativo para almacenar una sustancia farmacológica liofilizada a granel que tiene una concentración de alrededor de 2 - 400 mg/mL a temperaturas superiores a -20ºC, más específicamente, 0 - 25ºC ó 2 - 8ºC.
ARP120104942A 2011-12-23 2012-12-21 Procedimiento para preparar formulaciones con alta concentracion de proteinas AR089434A1 (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US201161579844P 2011-12-23 2011-12-23

Publications (1)

Publication Number Publication Date
AR089434A1 true AR089434A1 (es) 2014-08-20

Family

ID=47561835

Family Applications (1)

Application Number Title Priority Date Filing Date
ARP120104942A AR089434A1 (es) 2011-12-23 2012-12-21 Procedimiento para preparar formulaciones con alta concentracion de proteinas

Country Status (2)

Country Link
AR (1) AR089434A1 (es)
WO (1) WO2013096791A1 (es)

Families Citing this family (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
IL312865B1 (en) 2013-09-11 2025-02-01 Eagle Biologics Inc Liquid protein formulations containing viscosity-reducing agents
SG11201702614SA (en) 2014-10-01 2017-04-27 Eagle Biolog Inc Polysaccharide and nucleic acid formulations containing viscosity-lowering agents
CN111148510A (zh) * 2017-09-15 2020-05-12 美国安进公司 用于治疗性蛋白质的冻干药物配制品的方法
CN108813635A (zh) * 2018-07-13 2018-11-16 张明正 一种分段超滤、完全收集的小分子肽口服液的制备方法
JP2022546400A (ja) * 2019-08-30 2022-11-04 カシーヴ バイオサイエンシズ，リミテッド・ライアビリティ・カンパニー 高濃度の薬理学的に活性な抗体の新規製剤
CA3182315A1 (en) * 2020-05-01 2021-11-04 Kashiv Biosciences, Llc An improved process of affinity chromatography
AU2021262609A1 (en) 2020-05-01 2022-12-22 Kashiv Biosciences, Llc An improved process of purification of protein
JP2024534185A (ja) * 2021-08-30 2024-09-18 ボード オブ リージェンツ，ザ ユニバーシティ オブ テキサス システム モノクローナル抗体乾燥粉末
CA3176410A1 (en) * 2021-09-24 2023-03-24 Kashiv Biosciences, Llc An improved process for preparation of stable protein solution

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