MX2022010654A - Metodos para reducir la degradacion de polisorbato en formulaciones farmacologicas. - Google Patents

Metodos para reducir la degradacion de polisorbato en formulaciones farmacologicas.

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Publication number
MX2022010654A
MX2022010654A MX2022010654A MX2022010654A MX2022010654A MX 2022010654 A MX2022010654 A MX 2022010654A MX 2022010654 A MX2022010654 A MX 2022010654A MX 2022010654 A MX2022010654 A MX 2022010654A MX 2022010654 A MX2022010654 A MX 2022010654A
Authority
MX
Mexico
Prior art keywords
methods
compositions
drug formulations
polysorbate degradation
reducing polysorbate
Prior art date
Application number
MX2022010654A
Other languages
English (en)
Inventor
Hui Xiao
Sisi Zhang
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 MX2022010654A publication Critical patent/MX2022010654A/es

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    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/543—Immunoassay; Biospecific binding assay; Materials therefor with an insoluble carrier for immobilising immunochemicals
    • G01N33/54306—Solid-phase reaction mechanisms
    • 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
    • A61K38/43—Enzymes; Proenzymes; Derivatives thereof
    • A61K38/46—Hydrolases (3)
    • A61K38/465—Hydrolases (3) acting on ester bonds (3.1), e.g. lipases, ribonucleases
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/68—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
    • G01N33/6803—General methods of protein analysis not limited to specific proteins or families of proteins
    • 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
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Y—ENZYMES
    • C12Y301/00—Hydrolases acting on ester bonds (3.1)
    • C12Y301/01—Carboxylic ester hydrolases (3.1.1)
    • C12Y301/01001—Carboxylesterase (3.1.1.1)
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/62—Systems in which the material investigated is excited whereby it emits light or causes a change in wavelength of the incident light
    • G01N21/63—Systems in which the material investigated is excited whereby it emits light or causes a change in wavelength of the incident light optically excited
    • G01N21/64—Fluorescence; Phosphorescence
    • G01N21/6428—Measuring fluorescence of fluorescent products of reactions or of fluorochrome labelled reactive substances, e.g. measuring quenching effects, using measuring "optrodes"
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
    • G01N30/02—Column chromatography
    • G01N30/62—Detectors specially adapted therefor
    • G01N30/72—Mass spectrometers
    • G01N30/7233—Mass spectrometers interfaced to liquid or supercritical fluid chromatograph
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
    • G01N30/02—Column chromatography
    • G01N30/62—Detectors specially adapted therefor
    • G01N30/72—Mass spectrometers
    • G01N30/7233—Mass spectrometers interfaced to liquid or supercritical fluid chromatograph
    • G01N30/724—Nebulising, aerosol formation or ionisation
    • G01N30/7266—Nebulising, aerosol formation or ionisation by electric field, e.g. electrospray
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/68—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/68—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
    • G01N33/6803—General methods of protein analysis not limited to specific proteins or families of proteins
    • G01N33/6848—Methods of protein analysis involving mass spectrometry
    • 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
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/573—Immunoassay; Biospecific binding assay; Materials therefor for enzymes or isoenzymes

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Immunology (AREA)
  • Molecular Biology (AREA)
  • Physics & Mathematics (AREA)
  • General Health & Medical Sciences (AREA)
  • Biomedical Technology (AREA)
  • Urology & Nephrology (AREA)
  • Hematology (AREA)
  • Biochemistry (AREA)
  • Analytical Chemistry (AREA)
  • General Physics & Mathematics (AREA)
  • Pathology (AREA)
  • Medicinal Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Microbiology (AREA)
  • Food Science & Technology (AREA)
  • Cell Biology (AREA)
  • Biotechnology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Bioinformatics & Computational Biology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Biophysics (AREA)
  • Epidemiology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Spectroscopy & Molecular Physics (AREA)
  • Organic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Dispersion Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Optics & Photonics (AREA)
  • Genetics & Genomics (AREA)
  • Wood Science & Technology (AREA)

Abstract

La presente descripción se refiere a composiciones con una menor cantidad residual de lipasas y métodos para producir dichas composiciones. En particular, se refiere a composiciones y métodos para producir dichas composiciones disminuyendo determinadas lipasas en las composiciones, tales como proteína tipo carboxilesterasa B-1 hepática y proteína tipo carboxilesterasa 1 hepática.
MX2022010654A 2020-02-27 2021-02-27 Metodos para reducir la degradacion de polisorbato en formulaciones farmacologicas. MX2022010654A (es)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US202062982346P 2020-02-27 2020-02-27
US202063021181P 2020-05-07 2020-05-07
US202063073125P 2020-09-01 2020-09-01
PCT/US2021/020133 WO2021174151A1 (en) 2020-02-27 2021-02-27 Methods of reducing polysorbate degradation in drug formulations

Publications (1)

Publication Number Publication Date
MX2022010654A true MX2022010654A (es) 2022-11-16

Family

ID=75173439

Family Applications (2)

Application Number Title Priority Date Filing Date
MX2022010601A MX2022010601A (es) 2020-02-27 2021-02-27 Analisis de proteinas de celula hospedera segun su actividad.
MX2022010654A MX2022010654A (es) 2020-02-27 2021-02-27 Metodos para reducir la degradacion de polisorbato en formulaciones farmacologicas.

Family Applications Before (1)

Application Number Title Priority Date Filing Date
MX2022010601A MX2022010601A (es) 2020-02-27 2021-02-27 Analisis de proteinas de celula hospedera segun su actividad.

Country Status (11)

Country Link
US (2) US20210268073A1 (es)
EP (2) EP4111206A1 (es)
JP (2) JP2023516950A (es)
KR (2) KR20220147626A (es)
CN (2) CN115516313A (es)
AU (2) AU2021228763A1 (es)
BR (2) BR112022016148A2 (es)
CA (2) CA3172037A1 (es)
IL (2) IL295607A (es)
MX (2) MX2022010601A (es)
WO (2) WO2021174151A1 (es)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
TW202045927A (zh) * 2019-02-27 2020-12-16 法商賽諾菲公司 以具內標之lc-ms於樣品中進行聚山梨醇酯定量之方法
JP2023539278A (ja) * 2020-08-31 2023-09-13 ジェネンテック， インコーポレイテッド バイオ医薬開発中のポリソルベート分解リスクを評価するためのハイスループット蛍光系エステラーゼ活性アッセイ
WO2023244521A1 (en) * 2022-06-17 2023-12-21 Regeneron Pharmaceuticals, Inc. Methods for characterizing host-cell proteins
CN116297915B (zh) * 2023-02-10 2023-12-01 中国食品药品检定研究院 聚山梨酯类辅料的分析鉴定方法

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US1522343A (en) 1923-05-02 1925-01-06 Thom Clarence Magnetic separator
NO155316C (no) 1982-04-23 1987-03-11 Sintef Fremgangsmaate for fremstilling av magnetiske polymerpartikler.
US7087411B2 (en) 1999-06-08 2006-08-08 Regeneron Pharmaceuticals, Inc. Fusion protein capable of binding VEGF
AR102198A1 (es) * 2014-10-09 2017-02-08 Regeneron Pharma Proceso para reducir partículas subvisibles en una formulación farmacéutica
US20210008199A1 (en) * 2019-07-10 2021-01-14 Regeneron Pharmaceuticals, Inc. Methods and compositions comprising reduced level of host cell proteins

Also Published As

Publication number Publication date
CA3172898A1 (en) 2021-09-02
EP4111207A1 (en) 2023-01-04
EP4111206A1 (en) 2023-01-04
JP2023516950A (ja) 2023-04-21
AU2021226595A1 (en) 2022-09-22
IL295870A (en) 2022-10-01
AU2021228763A1 (en) 2022-09-15
KR20220147632A (ko) 2022-11-03
JP2023516949A (ja) 2023-04-21
CA3172037A1 (en) 2021-09-02
BR112022016148A2 (pt) 2022-10-04
CN115516313A (zh) 2022-12-23
WO2021174153A1 (en) 2021-09-02
US20210268073A1 (en) 2021-09-02
CN115485562A (zh) 2022-12-16
KR20220147626A (ko) 2022-11-03
MX2022010601A (es) 2022-09-09
US20210270824A1 (en) 2021-09-02
WO2021174151A1 (en) 2021-09-02
BR112022016744A2 (pt) 2022-10-18
IL295607A (en) 2022-10-01

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