WO2022026798A1 - Surfaces de contact communes destinées à être utilisées dans la fabrication, l'emballage, la distribution et l'évaluation de produits biopharmaceutiques - Google Patents

Surfaces de contact communes destinées à être utilisées dans la fabrication, l'emballage, la distribution et l'évaluation de produits biopharmaceutiques Download PDF

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Publication number
WO2022026798A1
WO2022026798A1 PCT/US2021/043845 US2021043845W WO2022026798A1 WO 2022026798 A1 WO2022026798 A1 WO 2022026798A1 US 2021043845 W US2021043845 W US 2021043845W WO 2022026798 A1 WO2022026798 A1 WO 2022026798A1
Authority
WO
WIPO (PCT)
Prior art keywords
vessels
layer
biopharmaceutical
coating
biopharmaceutical product
Prior art date
Application number
PCT/US2021/043845
Other languages
English (en)
Inventor
Robert S. Abrams
Christopher Weikart
Ahmad TAHA
Original Assignee
Sio2 Medical Products, 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 Sio2 Medical Products, Inc. filed Critical Sio2 Medical Products, Inc.
Priority to KR1020237007220A priority Critical patent/KR20230088338A/ko
Publication of WO2022026798A1 publication Critical patent/WO2022026798A1/fr

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Classifications

    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12M—APPARATUS FOR ENZYMOLOGY OR MICROBIOLOGY; APPARATUS FOR CULTURING MICROORGANISMS FOR PRODUCING BIOMASS, FOR GROWING CELLS OR FOR OBTAINING FERMENTATION OR METABOLIC PRODUCTS, i.e. BIOREACTORS OR FERMENTERS
    • C12M23/00—Constructional details, e.g. recesses, hinges
    • C12M23/20—Material Coatings
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12M—APPARATUS FOR ENZYMOLOGY OR MICROBIOLOGY; APPARATUS FOR CULTURING MICROORGANISMS FOR PRODUCING BIOMASS, FOR GROWING CELLS OR FOR OBTAINING FERMENTATION OR METABOLIC PRODUCTS, i.e. BIOREACTORS OR FERMENTERS
    • C12M23/00—Constructional details, e.g. recesses, hinges
    • C12M23/58—Reaction vessels connected in series or in parallel
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12M—APPARATUS FOR ENZYMOLOGY OR MICROBIOLOGY; APPARATUS FOR CULTURING MICROORGANISMS FOR PRODUCING BIOMASS, FOR GROWING CELLS OR FOR OBTAINING FERMENTATION OR METABOLIC PRODUCTS, i.e. BIOREACTORS OR FERMENTERS
    • C12M29/00—Means for introduction, extraction or recirculation of materials, e.g. pumps
    • C12M29/04—Filters; Permeable or porous membranes or plates, e.g. dialysis

Landscapes

  • Health & Medical Sciences (AREA)
  • Organic Chemistry (AREA)
  • Wood Science & Technology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Zoology (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Genetics & Genomics (AREA)
  • Biochemistry (AREA)
  • General Engineering & Computer Science (AREA)
  • General Health & Medical Sciences (AREA)
  • Sustainable Development (AREA)
  • Microbiology (AREA)
  • Biotechnology (AREA)
  • Biomedical Technology (AREA)
  • Clinical Laboratory Science (AREA)
  • Immunology (AREA)
  • Micro-Organisms Or Cultivation Processes Thereof (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Apparatus Associated With Microorganisms And Enzymes (AREA)

Abstract

La présente invention concerne un système de récipients, de raccords ou d'autres équipements caractérisé en ce qu'au moins certaines surfaces communes se trouvent en contact avec un produit biopharmaceutique pendant la fabrication, l'emballage, la distribution et l'évaluation de produits biopharmaceutiques. Au moins l'un des récipients est une membrane de filtration caractérisée par au moins certaines surfaces communes en contact avec un produit biopharmaceutique. La présente invention concerne en outre des procédés de production de ces systèmes et de personnalisation des surfaces de contact à utiliser dans ces derniers.
PCT/US2021/043845 2020-07-30 2021-07-30 Surfaces de contact communes destinées à être utilisées dans la fabrication, l'emballage, la distribution et l'évaluation de produits biopharmaceutiques WO2022026798A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
KR1020237007220A KR20230088338A (ko) 2020-07-30 2021-07-30 바이오의약 제품의 제조, 포장, 전달 및 평가에 사용하기 위한 공통 접촉 표면

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US202063059035P 2020-07-30 2020-07-30
US63/059,035 2020-07-30

Publications (1)

Publication Number Publication Date
WO2022026798A1 true WO2022026798A1 (fr) 2022-02-03

Family

ID=77431412

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2021/043845 WO2022026798A1 (fr) 2020-07-30 2021-07-30 Surfaces de contact communes destinées à être utilisées dans la fabrication, l'emballage, la distribution et l'évaluation de produits biopharmaceutiques

Country Status (2)

Country Link
KR (1) KR20230088338A (fr)
WO (1) WO2022026798A1 (fr)

Citations (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7985188B2 (en) 2009-05-13 2011-07-26 Cv Holdings Llc Vessel, coating, inspection and processing apparatus
US20150290080A1 (en) * 2013-03-11 2015-10-15 Sio2 Medical Products, Inc. Trilayer coated pharmaceutical packaging with low oxygen transmission rate
US20150297800A1 (en) 2012-07-03 2015-10-22 Sio2 Medical Products, Inc. SiOx BARRIER FOR PHARMACEUTICAL PACKAGE AND COATING PROCESS
US9272095B2 (en) 2011-04-01 2016-03-01 Sio2 Medical Products, Inc. Vessels, contact surfaces, and coating and inspection apparatus and methods
US9458536B2 (en) 2009-07-02 2016-10-04 Sio2 Medical Products, Inc. PECVD coating methods for capped syringes, cartridges and other articles
US9545360B2 (en) 2009-05-13 2017-01-17 Sio2 Medical Products, Inc. Saccharide protective coating for pharmaceutical package
US9554968B2 (en) 2013-03-11 2017-01-31 Sio2 Medical Products, Inc. Trilayer coated pharmaceutical packaging
WO2017087032A1 (fr) * 2015-11-16 2017-05-26 Sio2 Medical Products, Inc. Substrat polymère ayant une surface présentant une adhésion de biomolécule, et articles thermoplastiques constitués de ce substrat
US9662450B2 (en) 2013-03-01 2017-05-30 Sio2 Medical Products, Inc. Plasma or CVD pre-treatment for lubricated pharmaceutical package, coating process and apparatus
US9764093B2 (en) 2012-11-30 2017-09-19 Sio2 Medical Products, Inc. Controlling the uniformity of PECVD deposition
US9863042B2 (en) 2013-03-15 2018-01-09 Sio2 Medical Products, Inc. PECVD lubricity vessel coating, coating process and apparatus providing different power levels in two phases
US9878101B2 (en) 2010-11-12 2018-01-30 Sio2 Medical Products, Inc. Cyclic olefin polymer vessels and vessel coating methods
WO2018194918A1 (fr) * 2017-04-14 2018-10-25 Sio2 Medical Products, Inc. Systèmes de revêtement sur des substrats en plastique qui inhibent la dégradation induite par des radicaux libres de produits biologiques dans un emballage primaire
WO2018217995A1 (fr) * 2017-05-24 2018-11-29 Formycon Ag Conditionnements pharmaceutiques pré-remplis stérilisables comprenant une formulation liquide d'un antagoniste du vegf

Patent Citations (17)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7985188B2 (en) 2009-05-13 2011-07-26 Cv Holdings Llc Vessel, coating, inspection and processing apparatus
US9545360B2 (en) 2009-05-13 2017-01-17 Sio2 Medical Products, Inc. Saccharide protective coating for pharmaceutical package
US9458536B2 (en) 2009-07-02 2016-10-04 Sio2 Medical Products, Inc. PECVD coating methods for capped syringes, cartridges and other articles
US9878101B2 (en) 2010-11-12 2018-01-30 Sio2 Medical Products, Inc. Cyclic olefin polymer vessels and vessel coating methods
US9272095B2 (en) 2011-04-01 2016-03-01 Sio2 Medical Products, Inc. Vessels, contact surfaces, and coating and inspection apparatus and methods
US20150297800A1 (en) 2012-07-03 2015-10-22 Sio2 Medical Products, Inc. SiOx BARRIER FOR PHARMACEUTICAL PACKAGE AND COATING PROCESS
US9764093B2 (en) 2012-11-30 2017-09-19 Sio2 Medical Products, Inc. Controlling the uniformity of PECVD deposition
US9662450B2 (en) 2013-03-01 2017-05-30 Sio2 Medical Products, Inc. Plasma or CVD pre-treatment for lubricated pharmaceutical package, coating process and apparatus
US9554968B2 (en) 2013-03-11 2017-01-31 Sio2 Medical Products, Inc. Trilayer coated pharmaceutical packaging
US20150290080A1 (en) * 2013-03-11 2015-10-15 Sio2 Medical Products, Inc. Trilayer coated pharmaceutical packaging with low oxygen transmission rate
US9937099B2 (en) 2013-03-11 2018-04-10 Sio2 Medical Products, Inc. Trilayer coated pharmaceutical packaging with low oxygen transmission rate
US10016338B2 (en) 2013-03-11 2018-07-10 Sio2 Medical Products, Inc. Trilayer coated pharmaceutical packaging
US9863042B2 (en) 2013-03-15 2018-01-09 Sio2 Medical Products, Inc. PECVD lubricity vessel coating, coating process and apparatus providing different power levels in two phases
WO2017087032A1 (fr) * 2015-11-16 2017-05-26 Sio2 Medical Products, Inc. Substrat polymère ayant une surface présentant une adhésion de biomolécule, et articles thermoplastiques constitués de ce substrat
US20180334545A1 (en) 2015-11-16 2018-11-22 Sio2 Medical Products, Inc. Polymeric surface having reduced biomolecule adhesion to thermoplastic articles of such substrate
WO2018194918A1 (fr) * 2017-04-14 2018-10-25 Sio2 Medical Products, Inc. Systèmes de revêtement sur des substrats en plastique qui inhibent la dégradation induite par des radicaux libres de produits biologiques dans un emballage primaire
WO2018217995A1 (fr) * 2017-05-24 2018-11-29 Formycon Ag Conditionnements pharmaceutiques pré-remplis stérilisables comprenant une formulation liquide d'un antagoniste du vegf

Non-Patent Citations (17)

* Cited by examiner, † Cited by third party
Title
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"Q7 Good Manufacturing Practice Guidelines for Active Pharmaceutical Ingredients (APIs", FDA DOCUMENT 71518, 2016
"Quality Systems Approach to Pharmaceutical CGMP Regulations", FDA DOCUMENT 71023, 2006
BOWEN LI ET AL.: "Trimethylamine N-oxide-derived zwitterionic polymers: A new class of ultralow fouling bioinspired materials", SCIENCE ADVANCES, vol. 5, no. 6, 14 June 2019 (2019-06-14), pages eaaw9562
CAS , no. 74-86-2
CAS, no. 74-85-1
HAJEETH THANKAPPAN ET AL., DEVELOPMENT OF PVDF ULTRAFILTRATION MEMBRANE WITH ZWITTERIONIC BLOCK COPOLYMER MICELLES AS A SELECTIVE LAYER. MEMBRANES (BASEL, vol. 9, no. 8, 1 August 2019 (2019-08-01), pages 93
HAMMOND M ET AL., PDA J. PHARM. SCI. TECHNOL., vol. 67, no. 2, 2013, pages 123 - 134
HONG MS ET AL., COMPUTERS AND CHEM ENGG., vol. 110, 2018, pages 106 - 114
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LADD, J ET AL.: "Zwitterionic Polymers Exhibiting High Resistance to Nonspecific Protein Adsorption from Human Serum and Plasma", BIOMACROMOLECULES, vol. 9, 2008, pages 1357 - 1361, XP055163636, DOI: 10.1021/bm701301s
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Also Published As

Publication number Publication date
KR20230088338A (ko) 2023-06-19

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