MX2023014859A - Metodo de reconstitucion de formulacion liofilizada. - Google Patents

Metodo de reconstitucion de formulacion liofilizada.

Info

Publication number
MX2023014859A
MX2023014859A MX2023014859A MX2023014859A MX2023014859A MX 2023014859 A MX2023014859 A MX 2023014859A MX 2023014859 A MX2023014859 A MX 2023014859A MX 2023014859 A MX2023014859 A MX 2023014859A MX 2023014859 A MX2023014859 A MX 2023014859A
Authority
MX
Mexico
Prior art keywords
lyophilized formulation
polypeptide
seq
amino acid
bispecific antibody
Prior art date
Application number
MX2023014859A
Other languages
English (en)
Inventor
Wei Qi
Cindy Ren
Original Assignee
Amgen 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 Amgen Inc filed Critical Amgen Inc
Publication of MX2023014859A publication Critical patent/MX2023014859A/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
    • 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
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • 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
    • 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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • 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
    • C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • 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
    • C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2803—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily
    • C07K16/2809—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily against the T-cell receptor (TcR)-CD3 complex
    • 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
    • C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2878—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the NGF-receptor/TNF-receptor superfamily, e.g. CD27, CD30, CD40, CD95
    • 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
    • C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/30—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants from tumour cells
    • C07K16/3076—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants from tumour cells against structure-related tumour-associated moieties
    • C07K16/3092—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants from tumour cells against structure-related tumour-associated moieties against tumour-associated mucins
    • 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
    • A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/30—Immunoglobulins specific features characterized by aspects of specificity or valency
    • C07K2317/31—Immunoglobulins specific features characterized by aspects of specificity or valency multispecific
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/60—Immunoglobulins specific features characterized by non-natural combinations of immunoglobulin fragments
    • C07K2317/62—Immunoglobulins specific features characterized by non-natural combinations of immunoglobulin fragments comprising only variable region components
    • C07K2317/622—Single chain antibody (scFv)
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/90—Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/94—Stability, e.g. half-life, pH, temperature or enzyme-resistance

Landscapes

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

Abstract

En la presente se describe un método que comprende (a) reconstituir una formulación liofilizada que comprende un polipéptido, un sacárido, un agente tensioactivo y un agente amortiguador, con un diluyente que comprende un alcohol aromático, un compuesto fenólico o un aminoácido con cadena lateral aromática, y (b) administrar la formulación reconstituida a un sujeto en necesidad de esto en un período de 12 horas de la reconstitución, en donde el polipéptido es un constructo de anticuerpo biespecífico, tal como un constructo de anticuerpo biespecífico que se une a DLL3 humana y CD3 humana y opcionalmente comprende la secuencia de aminoácidos de SEQ ID NO: 75 y SEQ ID NO: 9.
MX2023014859A 2021-06-30 2022-06-29 Metodo de reconstitucion de formulacion liofilizada. MX2023014859A (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US202163216616P 2021-06-30 2021-06-30
PCT/US2022/035533 WO2023278585A1 (en) 2021-06-30 2022-06-29 Method of reconstituting lyophilized formulation

Publications (1)

Publication Number Publication Date
MX2023014859A true MX2023014859A (es) 2024-01-17

Family

ID=82701881

Family Applications (1)

Application Number Title Priority Date Filing Date
MX2023014859A MX2023014859A (es) 2021-06-30 2022-06-29 Metodo de reconstitucion de formulacion liofilizada.

Country Status (11)

Country Link
US (1) US20240316194A1 (es)
EP (1) EP4363448A1 (es)
JP (1) JP2024525482A (es)
KR (1) KR20240027701A (es)
CN (1) CN117377695A (es)
AU (1) AU2022304662A1 (es)
CA (1) CA3220933A1 (es)
CL (1) CL2023003713A1 (es)
IL (1) IL308847A (es)
MX (1) MX2023014859A (es)
WO (1) WO2023278585A1 (es)

Family Cites Families (23)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4475196A (en) 1981-03-06 1984-10-02 Zor Clair G Instrument for locating faults in aircraft passenger reading light and attendant call control system
US4447233A (en) 1981-04-10 1984-05-08 Parker-Hannifin Corporation Medication infusion pump
US4439196A (en) 1982-03-18 1984-03-27 Merck & Co., Inc. Osmotic drug delivery system
US4447224A (en) 1982-09-20 1984-05-08 Infusaid Corporation Variable flow implantable infusion apparatus
US4487603A (en) 1982-11-26 1984-12-11 Cordis Corporation Implantable microinfusion pump system
US4486194A (en) 1983-06-08 1984-12-04 James Ferrara Therapeutic device for administering medicaments through the skin
US4596556A (en) 1985-03-25 1986-06-24 Bioject, Inc. Hypodermic injection apparatus
US4751180A (en) 1985-03-28 1988-06-14 Chiron Corporation Expression using fused genes providing for protein product
US4935233A (en) 1985-12-02 1990-06-19 G. D. Searle And Company Covalently linked polypeptide cell modulators
DE3856559T2 (de) 1987-05-21 2004-04-29 Micromet Ag Multifunktionelle Proteine mit vorbestimmter Zielsetzung
US4790824A (en) 1987-06-19 1988-12-13 Bioject, Inc. Non-invasive hypodermic injection device
US4941880A (en) 1987-06-19 1990-07-17 Bioject, Inc. Pre-filled ampule and non-invasive hypodermic injection device assembly
US5312335A (en) 1989-11-09 1994-05-17 Bioject Inc. Needleless hypodermic injection device
US5064413A (en) 1989-11-09 1991-11-12 Bioject, Inc. Needleless hypodermic injection device
US5383851A (en) 1992-07-24 1995-01-24 Bioject Inc. Needleless hypodermic injection device
US20020103345A1 (en) 2000-05-24 2002-08-01 Zhenping Zhu Bispecific immunoglobulin-like antigen binding proteins and method of production
JP2008512352A (ja) 2004-07-17 2008-04-24 イムクローン システムズ インコーポレイティド 新規な四価の二重特異性抗体
WO2009032782A2 (en) 2007-08-28 2009-03-12 Biogen Idec Ma Inc. Compositions that bind multiple epitopes of igf-1r
TWI793062B (zh) * 2015-07-31 2023-02-21 德商安美基研究（慕尼黑）公司 Ｄｌｌ３及ｃｄ３抗體構築體
MX2019013142A (es) * 2017-05-05 2019-12-16 Amgen Inc Composicion farmaceutica que comprende construcciones de anticuerpos biespecificas para mejorar el almacenamiento y la administracion.
KR20200036889A (ko) * 2017-07-28 2020-04-07 에프. 호프만-라 로슈 아게 이중특이성 항체 제형
UY38041A (es) * 2017-12-29 2019-06-28 Amgen Inc Construcción de anticuerpo biespecífico dirigida a muc17 y cd3
KR20210070314A (ko) * 2018-10-01 2021-06-14 암젠 인크 이중특이적 항체의 응집을 감소시키는 방법

Also Published As

Publication number Publication date
KR20240027701A (ko) 2024-03-04
CL2023003713A1 (es) 2024-06-21
EP4363448A1 (en) 2024-05-08
AU2022304662A1 (en) 2023-11-23
CN117377695A (zh) 2024-01-09
JP2024525482A (ja) 2024-07-12
WO2023278585A1 (en) 2023-01-05
AU2022304662A9 (en) 2023-11-30
CA3220933A1 (en) 2023-01-05
US20240316194A1 (en) 2024-09-26
IL308847A (en) 2024-01-01

Similar Documents

Publication Publication Date Title
CA2226575A1 (en) Stabile isotonic lyophilized protein formulation
IL273255B1 (en) Preparations and methods for lyophilization of bacterial strains and listeria
EP2532366A4 (en) PHARMACEUTICAL COMPOSITION FOR THE TREATMENT AND / OR PREVENTION OF CANCER
WO2003106644A3 (en) RESPIRATORY SYNCYTIAL ANTI-VIRUS ANTIBODY FORMULATIONS (RSV) STABILIZED
CA2371714A1 (en) Streptococcus pneumoniae proteins and vaccines
US20220242941A1 (en) Antibodies against disease causing agents of poultry and uses thereof
AU691881B2 (en) Pharmaceutical preparation containing plasminogen activators
EP4226938A3 (en) Coronavirus vaccine
Rodríguez‐Mallon et al. A chemical conjugate of the tick P0 peptide is efficacious against Amblyomma mixtum
TW202304955A (zh) 冠狀病毒疫苗配製品
RU2011146424A (ru) Антитела или их фрагменты, направленные против эпитопа стафилококка золотистого (staphylococcus aureus)
WO2022036142A3 (en) Ras neoantigens and uses thereof
MX2023006403A (es) Composiciones y métodos para el suministro de ácidos nucleicos a las células.
SA521430229B1 (ar) Il-33 صيغ ثابتة تحتوي على أجسام مضادة لـ
MX2023014859A (es) Metodo de reconstitucion de formulacion liofilizada.
Calderón et al. Inhibition of the myotoxic activity of Bothrops asper myotoxin II in mice by immunization with its synthetic 13-mer peptide 115–129
MX2023002480A (es) "composiciones y métodos para el suministro de ácidos nucleicos a las células.
JP7085482B2 (ja) スタフィロコッカス感染症のための凍結乾燥製剤を製造する方法
JP2012502625A (ja) 樹状細胞調節分子
WO2021050857A8 (en) Anti-cd371 antibodies and uses thereof
US20180360943A1 (en) Lipidated streptococcus pneumoniae antigen compositions, methods of preparation and use
US7579003B2 (en) HBsAg-BCG combined vaccine for intracutaneous injection and preparation method thereof
MX2022009549A (es) Tratamiento que implica vacunacion con antigeno y agentes de union que se unen a pd-l1 y cd137.
Marchalonis Immunoglobulins and antibody-production in amphibians
MX2022014650A (es) Formulacion que contiene anticuerpo.