CO2023006410A2 - Método de control del contenido total de ácido siálico (ctas) durante la fabricación de fosfatasa alcalina referencia cruzada a solicitudes relacionadas - Google Patents

Método de control del contenido total de ácido siálico (ctas) durante la fabricación de fosfatasa alcalina referencia cruzada a solicitudes relacionadas

Info

Publication number
CO2023006410A2
CO2023006410A2 CONC2023/0006410A CO2023006410A CO2023006410A2 CO 2023006410 A2 CO2023006410 A2 CO 2023006410A2 CO 2023006410 A CO2023006410 A CO 2023006410A CO 2023006410 A2 CO2023006410 A2 CO 2023006410A2
Authority
CO
Colombia
Prior art keywords
ctas
sialic acid
control method
related applications
cross reference
Prior art date
Application number
CONC2023/0006410A
Other languages
English (en)
Inventor
Meghan Dewitt
Siguang Sui
Rahul Godawat
Sarah Berendes
Original Assignee
Alexion Pharma 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 Alexion Pharma Inc filed Critical Alexion Pharma Inc
Publication of CO2023006410A2 publication Critical patent/CO2023006410A2/es

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00Drugs for skeletal disorders
    • A61P19/08Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12NMICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N9/00Enzymes; Proenzymes; Compositions thereof; Processes for preparing, activating, inhibiting, separating or purifying enzymes
    • C12N9/14Hydrolases (3)
    • C12N9/16Hydrolases (3) acting on ester bonds (3.1)
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2319/00Fusion polypeptide
    • C07K2319/30Non-immunoglobulin-derived peptide or protein having an immunoglobulin constant or Fc region, or a fragment thereof, attached thereto
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12YENZYMES
    • C12Y301/00Hydrolases acting on ester bonds (3.1)
    • C12Y301/03Phosphoric monoester hydrolases (3.1.3)
    • C12Y301/03001Alkaline phosphatase (3.1.3.1)

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Organic Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Genetics & Genomics (AREA)
  • Wood Science & Technology (AREA)
  • Zoology (AREA)
  • General Health & Medical Sciences (AREA)
  • Biochemistry (AREA)
  • General Engineering & Computer Science (AREA)
  • Medicinal Chemistry (AREA)
  • Biotechnology (AREA)
  • Biomedical Technology (AREA)
  • Molecular Biology (AREA)
  • Microbiology (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Public Health (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Rheumatology (AREA)
  • Veterinary Medicine (AREA)
  • Peptides Or Proteins (AREA)
  • Enzymes And Modification Thereof (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
  • Investigating Or Analysing Biological Materials (AREA)
  • Micro-Organisms Or Cultivation Processes Thereof (AREA)
  • Measuring Or Testing Involving Enzymes Or Micro-Organisms (AREA)

Abstract

Se presentan métodos de fabricación de fosfatasas alcalinas recombinantes, tales como asfotasa alfa, que proporcionan un control de calidad más preciso frente a la concentración del contenido total de ácido siálico (CTAS) en el producto final midiendo la concentración de CTAS durante la fermentación y ajustando los pasos de producción aguas abajo en respuesta.
CONC2023/0006410A 2020-10-23 2023-05-16 Método de control del contenido total de ácido siálico (ctas) durante la fabricación de fosfatasa alcalina referencia cruzada a solicitudes relacionadas CO2023006410A2 (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US202063105052P 2020-10-23 2020-10-23
PCT/US2021/055991 WO2022087229A1 (en) 2020-10-23 2021-10-21 Method of controlling total sialic acid content (tsac) during manufacturing of alkaline phosphatase

Publications (1)

Publication Number Publication Date
CO2023006410A2 true CO2023006410A2 (es) 2023-08-09

Family

ID=81290076

Family Applications (1)

Application Number Title Priority Date Filing Date
CONC2023/0006410A CO2023006410A2 (es) 2020-10-23 2023-05-16 Método de control del contenido total de ácido siálico (ctas) durante la fabricación de fosfatasa alcalina referencia cruzada a solicitudes relacionadas

Country Status (10)

Country Link
US (1) US20240052327A1 (es)
EP (1) EP4232150A1 (es)
JP (1) JP2023546682A (es)
KR (1) KR20230088811A (es)
CN (1) CN116670270A (es)
AU (1) AU2021364779A1 (es)
CA (1) CA3173820A1 (es)
CO (1) CO2023006410A2 (es)
MX (1) MX2023004621A (es)
WO (1) WO2022087229A1 (es)

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7112341B1 (en) * 1999-04-13 2006-09-26 Nektar Therapeutics Pulmonary administration of dry powder formulations for treating infertility
KR101380740B1 (ko) * 2012-06-29 2014-04-11 쉐어 휴먼 제네텍 세러피스, 인코포레이티드 이듀로네이트-2-설파타제의 정제
CN106459143A (zh) * 2014-01-24 2017-02-22 安-法玛公司 碱性磷酸酶的下游处理
EP3337894A1 (en) * 2015-08-17 2018-06-27 Alexion Pharmaceuticals, Inc. Manufacturing of alkaline phosphatases
WO2017214130A1 (en) * 2016-06-06 2017-12-14 Alexion Pharmaceuticals, Inc. Metal impact on manufacturing of alkaline phosphatases

Also Published As

Publication number Publication date
MX2023004621A (es) 2023-06-06
KR20230088811A (ko) 2023-06-20
EP4232150A1 (en) 2023-08-30
WO2022087229A1 (en) 2022-04-28
CA3173820A1 (en) 2022-04-28
JP2023546682A (ja) 2023-11-07
AU2021364779A9 (en) 2023-07-06
CN116670270A (zh) 2023-08-29
AU2021364779A1 (en) 2023-06-01
US20240052327A1 (en) 2024-02-15

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