SG11201605626SA - Sterile chromatography and manufacturing processes - Google Patents

Sterile chromatography and manufacturing processes

Info

Publication number
SG11201605626SA
SG11201605626SA SG11201605626SA SG11201605626SA SG11201605626SA SG 11201605626S A SG11201605626S A SG 11201605626SA SG 11201605626S A SG11201605626S A SG 11201605626SA SG 11201605626S A SG11201605626S A SG 11201605626SA SG 11201605626S A SG11201605626S A SG 11201605626SA
Authority
SG
Singapore
Prior art keywords
manufacturing processes
sterile chromatography
sterile
chromatography
processes
Prior art date
Application number
SG11201605626SA
Inventor
Rahul Godawat
Veena Warikoo
Rohan Patil
Konstantin Konstantinov
Venkat Kishore Ryakala
Mahsa Rohani
Original Assignee
Genzyme Corp
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 Genzyme Corp filed Critical Genzyme Corp
Publication of SG11201605626SA publication Critical patent/SG11201605626SA/en

Links

Classifications

    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K1/00—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
    • C07K1/14—Extraction; Separation; Purification
    • C07K1/16—Extraction; Separation; Purification by chromatography
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/02—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using physical phenomena
    • A61L2/08—Radiation
    • A61L2/081—Gamma radiation
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D15/00—Separating processes involving the treatment of liquids with solid sorbents; Apparatus therefor
    • B01D15/08—Selective adsorption, e.g. chromatography
    • B01D15/10—Selective adsorption, e.g. chromatography characterised by constructional or operational features
    • B01D15/18—Selective adsorption, e.g. chromatography characterised by constructional or operational features relating to flow patterns
    • B01D15/1807—Selective adsorption, e.g. chromatography characterised by constructional or operational features relating to flow patterns using counter-currents, e.g. fluidised beds
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D15/00—Separating processes involving the treatment of liquids with solid sorbents; Apparatus therefor
    • B01D15/08—Selective adsorption, e.g. chromatography
    • B01D15/10—Selective adsorption, e.g. chromatography characterised by constructional or operational features
    • B01D15/18—Selective adsorption, e.g. chromatography characterised by constructional or operational features relating to flow patterns
    • B01D15/1864—Selective adsorption, e.g. chromatography characterised by constructional or operational features relating to flow patterns using two or more columns
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D15/00—Separating processes involving the treatment of liquids with solid sorbents; Apparatus therefor
    • B01D15/08—Selective adsorption, e.g. chromatography
    • B01D15/10—Selective adsorption, e.g. chromatography characterised by constructional or operational features
    • B01D15/20—Selective adsorption, e.g. chromatography characterised by constructional or operational features relating to the conditioning of the sorbent material
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D15/00—Separating processes involving the treatment of liquids with solid sorbents; Apparatus therefor
    • B01D15/08—Selective adsorption, e.g. chromatography
    • B01D15/26—Selective adsorption, e.g. chromatography characterised by the separation mechanism
    • B01D15/36—Selective adsorption, e.g. chromatography characterised by the separation mechanism involving ionic interaction
    • B01D15/361—Ion-exchange
    • B01D15/363—Anion-exchange
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D15/00—Separating processes involving the treatment of liquids with solid sorbents; Apparatus therefor
    • B01D15/08—Selective adsorption, e.g. chromatography
    • B01D15/26—Selective adsorption, e.g. chromatography characterised by the separation mechanism
    • B01D15/38—Selective adsorption, e.g. chromatography characterised by the separation mechanism involving specific interaction not covered by one or more of groups B01D15/265 - B01D15/36
    • B01D15/3804—Affinity chromatography
    • B01D15/3809—Affinity chromatography of the antigen-antibody type, e.g. protein A, G, L chromatography
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D15/00—Separating processes involving the treatment of liquids with solid sorbents; Apparatus therefor
    • B01D15/08—Selective adsorption, e.g. chromatography
    • B01D15/42—Selective adsorption, e.g. chromatography characterised by the development mode, e.g. by displacement or by elution
    • B01D15/424—Elution mode
    • B01D15/426—Specific type of solvent
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K1/00—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
    • C07K1/14—Extraction; Separation; Purification
    • C07K1/16—Extraction; Separation; Purification by chromatography
    • C07K1/165—Extraction; Separation; Purification by chromatography mixed-mode chromatography
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K1/00—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
    • C07K1/14—Extraction; Separation; Purification
    • C07K1/16—Extraction; Separation; Purification by chromatography
    • C07K1/22—Affinity chromatography or related techniques based upon selective absorption processes
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N9/00—Enzymes; Proenzymes; Compositions thereof; Processes for preparing, activating, inhibiting, separating or purifying enzymes
    • C12N9/14—Hydrolases (3)
    • C12N9/24—Hydrolases (3) acting on glycosyl compounds (3.2)
    • C12N9/2402—Hydrolases (3) acting on glycosyl compounds (3.2) hydrolysing O- and S- glycosyl compounds (3.2.1)
    • C12N9/2465—Hydrolases (3) acting on glycosyl compounds (3.2) hydrolysing O- and S- glycosyl compounds (3.2.1) acting on alpha-galactose-glycoside bonds, e.g. alpha-galactosidase (3.2.1.22)
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Y—ENZYMES
    • C12Y302/00—Hydrolases acting on glycosyl compounds, i.e. glycosylases (3.2)
    • C12Y302/01—Glycosidases, i.e. enzymes hydrolysing O- and S-glycosyl compounds (3.2.1)
    • C12Y302/01022—Alpha-galactosidase (3.2.1.22)

Landscapes

  • Chemical & Material Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Organic Chemistry (AREA)
  • Analytical Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Genetics & Genomics (AREA)
  • General Health & Medical Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Medicinal Chemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biophysics (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Zoology (AREA)
  • Wood Science & Technology (AREA)
  • Engineering & Computer Science (AREA)
  • General Engineering & Computer Science (AREA)
  • Biotechnology (AREA)
  • Biomedical Technology (AREA)
  • Microbiology (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Immunology (AREA)
  • Peptides Or Proteins (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
  • Treatment Of Liquids With Adsorbents In General (AREA)
SG11201605626SA 2014-01-17 2015-01-16 Sterile chromatography and manufacturing processes SG11201605626SA (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201461928906P 2014-01-17 2014-01-17
PCT/US2015/011698 WO2015109146A1 (en) 2014-01-17 2015-01-16 Sterile chromatography and manufacturing processes

Publications (1)

Publication Number Publication Date
SG11201605626SA true SG11201605626SA (en) 2016-08-30

Family

ID=52630479

Family Applications (1)

Application Number Title Priority Date Filing Date
SG11201605626SA SG11201605626SA (en) 2014-01-17 2015-01-16 Sterile chromatography and manufacturing processes

Country Status (19)

Country Link
US (4) US10087214B2 (en)
EP (1) EP3094640B1 (en)
JP (2) JP6691047B2 (en)
KR (1) KR102326354B1 (en)
CN (1) CN106103464B (en)
AU (1) AU2015206422B2 (en)
BR (1) BR112016016329B1 (en)
CA (1) CA2936951C (en)
CY (1) CY1124062T1 (en)
DK (1) DK3094640T3 (en)
ES (1) ES2841141T3 (en)
HK (1) HK1227042B (en)
HU (1) HUE052611T2 (en)
IL (1) IL246774B (en)
MX (1) MX2016009295A (en)
RU (1) RU2679133C2 (en)
SG (1) SG11201605626SA (en)
TW (2) TWI709570B (en)
WO (1) WO2015109146A1 (en)

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SG11201506343QA (en) 2013-02-22 2015-09-29 Genzyme Corp Microcarrier perfusion culturing methods and uses thereof
CN105143443A (en) 2013-02-22 2015-12-09 建新公司 Microcarrier perfusion culturing methods and uses thereof
MX2015012114A (en) 2013-03-08 2016-01-12 Genzyme Corp Continuous purification of therapeutic proteins.
TWI709570B (en) 2014-01-17 2020-11-11 美商健臻公司 Sterile chromatography and manufacturing processes
TWI709569B (en) 2014-01-17 2020-11-11 美商健臻公司 Sterile chromatography resin and use thereof in manufacturing processes
TW202204596A (en) 2014-06-06 2022-02-01 美商健臻公司 Perfusion culturing methods and uses thereof
TW202246486A (en) 2014-06-09 2022-12-01 美商健臻公司 Seed train processes and uses thereof
EP3237604A2 (en) 2014-12-22 2017-11-01 Genzyme Corporation Methods of culturing a mammalian cell
DE102015005244A1 (en) * 2015-04-24 2016-11-10 Sartorius Stedim Biotech Gmbh Method for sterilizing a chromatography material and then sterilized chromatography material
CN112292601A (en) * 2018-05-24 2021-01-29 西格马-奥尔德里奇有限责任公司 Quantitative analysis of proteins
JP2021536353A (en) 2018-08-31 2021-12-27 ジェンザイム・コーポレーション Aseptic chromatographic resin and its use in manufacturing methods
MX2022004817A (en) 2019-10-22 2022-06-16 Genzyme Corp In-line product monitoring in integrated continuous bio-manufacturing.
CN115475258A (en) * 2022-09-06 2022-12-16 江苏丰华生物制药有限公司 Purification process of tenecteplase for injection

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