AR089434A1 - PROCEDURE TO PREPARE FORMULATIONS WITH HIGH CONCENTRATION OF PROTEINS - Google Patents

PROCEDURE TO PREPARE FORMULATIONS WITH HIGH CONCENTRATION OF PROTEINS

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
Spanish (es)
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/en

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39591Stabilisation, fragmentation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183Amino acids, e.g. glycine, EDTA or aspartame
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19Particulate 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
    • 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
    • C07K16/24Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
    • C07K16/244Interleukins [IL]
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/42Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against immunoglobulins
    • C07K16/4283Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against immunoglobulins against an allotypic or isotypic determinant on Ig
    • C07K16/4291Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against immunoglobulins against an allotypic or isotypic determinant on Ig against IgE
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/20Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/24Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered

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.Process for preparing high concentration liquid protein formulations even under conditions of high viscosity that could make the process of tangential fluid filtration (TFF) prohibitive. Process for creating protein drug product formulations that have a concentration of approximately 50-700 mg / ml, and / or a viscosity of at least 40 cP. Alternative manufacturing process whereby protein formulations (e.g., polypeptide or antibody) are prepared using a bulk lyophilization and reconstitution process (BLRP). Improved process to prepare liquid protein formulations, which can be stored avoiding the cost and inconvenience of freezing and maintenance at -20ºC. Alternative method for storing a freeze-dried bulk drug substance having a concentration of about 2-400 mg / mL at temperatures above -20 ° C, more specifically, 0-25 ° C or 2-8 ° C.

ARP120104942A 2011-12-23 2012-12-21 PROCEDURE TO PREPARE FORMULATIONS WITH HIGH CONCENTRATION OF PROTEINS AR089434A1 (en)

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 (en) 2014-08-20

Family

ID=47561835

Family Applications (1)

Application Number Title Priority Date Filing Date
ARP120104942A AR089434A1 (en) 2011-12-23 2012-12-21 PROCEDURE TO PREPARE FORMULATIONS WITH HIGH CONCENTRATION OF PROTEINS

Country Status (2)

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

Families Citing this family (7)

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KR102651018B1 (en) 2013-09-11 2024-03-27 이글 바이오로직스 인코퍼레이티드 Liquid protein formulations containing viscosity-lowering agents
US11471479B2 (en) 2014-10-01 2022-10-18 Eagle Biologics, Inc. Polysaccharide and nucleic acid formulations containing viscosity-lowering agents
IL272513B2 (en) * 2017-09-15 2023-04-01 Amgen Inc Process for lyophilized pharmaceutical formulation of a therapeutic protein
CN108813635A (en) * 2018-07-13 2018-11-16 张明正 A kind of preparation method being segmented ultrafiltration, the small-molecular peptides oral solution collected completely
JP2022546400A (en) * 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 Novel formulations of high concentrations of pharmacologically active antibodies
WO2023034795A1 (en) * 2021-08-30 2023-03-09 Board Of Regents, The University Of Texas System Monoclonal antibody dry powders
CA3176410A1 (en) * 2021-09-24 2023-03-24 Kashiv Biosciences, Llc An improved process for preparation of stable protein solution

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