WO2013007584A1 - Procédé de stérilisation de surfaces revêtues fonctionnalisées contenant des nucléotides et/ou des dérivés nucléotidiques - Google Patents

Procédé de stérilisation de surfaces revêtues fonctionnalisées contenant des nucléotides et/ou des dérivés nucléotidiques Download PDF

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Publication number
WO2013007584A1
WO2013007584A1 PCT/EP2012/063087 EP2012063087W WO2013007584A1 WO 2013007584 A1 WO2013007584 A1 WO 2013007584A1 EP 2012063087 W EP2012063087 W EP 2012063087W WO 2013007584 A1 WO2013007584 A1 WO 2013007584A1
Authority
WO
WIPO (PCT)
Prior art keywords
coating
nucleotide derivatives
nucleotides
coated
irradiation
Prior art date
Application number
PCT/EP2012/063087
Other languages
German (de)
English (en)
Other versions
WO2013007584A8 (fr
Inventor
Peter BREHM CHIRURGIE MECHANIK E.K.
Matthias Müller
Judith REICHERT
Anne FÖRSTER
Bernd Schwenzer
Dieter Scharnweber
Original Assignee
Technische Universität Dresden
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 Technische Universität Dresden filed Critical Technische Universität Dresden
Priority to EP12735115.3A priority Critical patent/EP2729186A1/fr
Publication of WO2013007584A1 publication Critical patent/WO2013007584A1/fr
Publication of WO2013007584A8 publication Critical patent/WO2013007584A8/fr

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L2/00Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/0005Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts
    • A61L2/0011Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts using physical methods
    • A61L2/0029Radiation
    • A61L2/0035Gamma radiation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A61K9/0024Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0087Galenical forms not covered by A61K9/02 - A61K9/7023
    • A61K9/0097Micromachined devices; Microelectromechanical systems [MEMS]; Devices obtained by lithographic treatment of silicon; Devices comprising chips
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L2202/00Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
    • A61L2202/20Targets to be treated
    • A61L2202/21Pharmaceuticals, e.g. medicaments, artificial body parts
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L2300/00Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/20Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing organic materials
    • A61L2300/258Genetic materials, DNA, RNA, genes, vectors, e.g. plasmids

Definitions

  • the invention relates to a method for the sterilization of functionalized, coated with nucleotides and / or nucleotide derivatives, coated surfaces.
  • the immobilization of nucleotides or nucleotide derivatives on solid support materials is of great importance for implantology and many areas of biotechnology.
  • WO 2004/005302 A2 discloses a metallic object coated with nucleic acids and nucleic acid derivatives and a method for its production and its use, in which nucleic acids and nucleic acid derivatives are immobilized for the production of sensors for biotechnology.
  • DE 10 2006 024 058 A1 discloses a modular system with immobilized nucleic acids or nucleic acid derivatives on metallic surfaces and a method for its production.
  • the production of generic functionalized coatings of surfaces and in particular of metal surfaces or wafer surfaces is thus a known technology in the prior art.
  • a treatment method known for these applications is irradiation with gamma rays in defined doses.
  • Such effects are mainly caused by the formation of reactive species due to the interaction of the ionizing radiation with components in the environment of the DNA.
  • nucleotides or nucleotide derivatives are understood as meaning compounds of these from oligonucleotides to high-molecular-weight DNA structures.
  • nucleotide derivatives for example, phosphotioates for increasing the nuclease stability and similar substances are understood.
  • the object is achieved, in particular, by a method for sterilizing functionalized, coated surfaces containing nucleotides or nucleotide derivatives, in which a) a functionalizing coating of the surface takes place in excess with nucleotides and / or nucleotide derivatives, wherein the excess nucleotides and / or Nucleotide derivatives as sacrificial strands are not washed out of the coating.
  • nucleotides and / or nucleotide derivatives are to be understood as meaning those which are not stably immobilized on the surface to be functionalized.
  • the atmosphere is enriched over the coated surface with ethanol, and in particular with anhydrous ethanol.
  • step c which consists in irradiation of the coated surface with ionizing radiation.
  • the method is formed by irradiation with gamma rays at a dose of 25-30 kGray.
  • An improvement of the method results can be achieved according to a development of the invention in that before the irradiation of the coated surface, a removal of water and oxygen from the coating and the surrounding atmosphere takes place.
  • P2O 5 phosphorus pentoxide
  • the enrichment of an argon protective gas atmosphere with anhydrous ethanol in the concentration of 1, 500 ⁇ to 100 ml volume is advantageous.
  • the method is further developed by the fact that the functionalizing coating of a layer of oligonucleotide single strands on a Titanium surface, or a titanium-containing surface is executed, or that a part of the strands is partially incorporated in anodically formed oxide. This embodiment is advantageously feasible, in particular for implants.
  • the functionalizing coating is made of a layer of oligonucleotide single strands on a monocrystalline silicon surface, also referred to as a wafer.
  • sterilized chips for the production of sensors can be produced by the method according to the invention.
  • the method according to the invention for the treatment of a coating also leads to advantageous effects when the functionalizing coating is in the form of a layer of oligonucleotide single strands on a surface of calcium phosphate phases.
  • the method according to the invention for treating a coating is also advantageously applicable if the functionalizing coating is designed in the form of a layer of oligonucleotide single strands on a polymer surface suitable for biomaterial applications.
  • the concept of the invention is that the combination of two parameters significantly improves the functionality of the treated nucleotide and / or nucleotide derivative structures.
  • the coating is formed with an excess of the nucleotide or nucleotide derivative strands.
  • an enrichment of the atmosphere with ethanol takes place before irradiation by means of ionizing radiation.
  • the method is further developed by combining the known strategies for avoiding oxygen and water with the measures according to the invention.
  • the stated measures lead to maintenance of the functionality, in particular the hybridization ability of the single strands of an oligonucleotide coating of up to 80% of the immobilized anchor strands after gamma sterilization.
  • the treatment according to the invention of functionally coated surfaces provides the prerequisite for effectively using developed immobilization methods according to the prior art for the functionalization of implant surfaces or for sensor production.
  • the samples were then dried in a desiccator over phosphorus pentoxide (P2O 5) and in a glove box under an argon protective gas atmosphere in airtight glass vessels, such as Duran bottles, packed with a volume of 100 ml.
  • P2O 5 phosphorus pentoxide
  • a volume of 1, 500 ⁇ anhydrous ethanol was added during the process of packaging.
  • the sealed samples were sterilized with gamma radiation at a dose of 25-30 kGray prescribed for medical devices.
  • the reference samples were each not sterilized.
  • the optimum combination under the conditions compared lies in the combination of dispensing with the rinsing and the associated desorption of the sacrificial strands with the accumulation of ethanol in the atmosphere before irradiation, which is indicated by the indication EtOH Atm in the figure.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Medicinal Chemistry (AREA)
  • Molecular Biology (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Apparatus Associated With Microorganisms And Enzymes (AREA)
  • Immobilizing And Processing Of Enzymes And Microorganisms (AREA)

Abstract

L'invention concerne un procédé de stérilisation de surfaces revêtues fonctionnalisées contenant des nucléotides et/ou des dérivés nucléotidiques, selon lequel : a) un revêtement fonctionnalisant de la surface est réalisé au moyen de nucléotides et/ou de dérivés nucléotidiques en excès, les nucléotides et/ou les dérivés nucléotidiques en excès faisant office de brins sacrificiels n'étant pas éliminés du revêtement par lavage; b) l'atmosphère au-dessus de la surface revêtue est enrichie en éthanol; et c) la surface revêtue est exposée à un rayonnement ionisant.
PCT/EP2012/063087 2011-07-08 2012-07-05 Procédé de stérilisation de surfaces revêtues fonctionnalisées contenant des nucléotides et/ou des dérivés nucléotidiques WO2013007584A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
EP12735115.3A EP2729186A1 (fr) 2011-07-08 2012-07-05 Procédé de stérilisation de surfaces revêtues fonctionnalisées contenant des nucléotides et/ou des dérivés nucléotidiques

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102011051692A DE102011051692A1 (de) 2011-07-08 2011-07-08 Verfahren zur Sterilisation von funktionalisierten, Nukleotide und/oder Nukleotidderivate enthaltenden, beschichteten Oberflächen
DE102011051692.1 2011-07-08

Publications (2)

Publication Number Publication Date
WO2013007584A1 true WO2013007584A1 (fr) 2013-01-17
WO2013007584A8 WO2013007584A8 (fr) 2013-04-11

Family

ID=46508329

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2012/063087 WO2013007584A1 (fr) 2011-07-08 2012-07-05 Procédé de stérilisation de surfaces revêtues fonctionnalisées contenant des nucléotides et/ou des dérivés nucléotidiques

Country Status (3)

Country Link
EP (1) EP2729186A1 (fr)
DE (1) DE102011051692A1 (fr)
WO (1) WO2013007584A1 (fr)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2014194931A1 (fr) * 2013-06-03 2014-12-11 Onderzoeks- En Ontwikkelingsfonds Rode Kruis-Vlaanderen Traitement de réduction d'agent pathogène

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0879595A2 (fr) * 1997-04-30 1998-11-25 Schneider (Usa) Inc. Couches délivrant des agents médicinaux pour dispositifs médicaux
WO2004005302A1 (fr) 2002-07-04 2004-01-15 Sigma Coatings B.V. Procede de preparation d'acyloxysilanes
EP1400248A1 (fr) * 2002-09-19 2004-03-24 Aventis Behring GmbH Procédé de stérilisation de compositions biologiques comprenant des protéines
DE102006024058A1 (de) 2006-05-16 2007-11-22 Technische Universität Dresden Modulares System mit immobilisierten Nukleinsäuren und/oder Nukleinsäurederivaten an metallischen Oberflächen und Verfahren zu dessen Herstelung
US20100166599A1 (en) * 2007-06-07 2010-07-01 Kowalski John B Method for establishing a sterilizing dose for radiation sensitive products
EP2208482A1 (fr) * 2007-10-12 2010-07-21 Microport Medical (Shanghai) Co., Ltd. Stent artificiel et procédé de préparation dudit stent

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20030095890A1 (en) * 2001-09-24 2003-05-22 Shirley Miekka Methods for sterilizing biological materials containing non-aqueous solvents
EP1566638A4 (fr) * 2002-11-25 2007-06-13 Nisshin Spinning Procede de fixation d'une biomolecule sur un support en metal
DE102007048591A1 (de) * 2007-10-05 2009-04-09 Matthias Prof. Dr. Epple Implantat und Verfahren zu seiner Herstellung
EP2058335B1 (fr) * 2007-11-07 2020-06-24 Leukocare Ag Matrice tridimensionnelle biocompatible pour l'immobilisation de substances biologiques

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0879595A2 (fr) * 1997-04-30 1998-11-25 Schneider (Usa) Inc. Couches délivrant des agents médicinaux pour dispositifs médicaux
WO2004005302A1 (fr) 2002-07-04 2004-01-15 Sigma Coatings B.V. Procede de preparation d'acyloxysilanes
EP1400248A1 (fr) * 2002-09-19 2004-03-24 Aventis Behring GmbH Procédé de stérilisation de compositions biologiques comprenant des protéines
DE102006024058A1 (de) 2006-05-16 2007-11-22 Technische Universität Dresden Modulares System mit immobilisierten Nukleinsäuren und/oder Nukleinsäurederivaten an metallischen Oberflächen und Verfahren zu dessen Herstelung
US20100166599A1 (en) * 2007-06-07 2010-07-01 Kowalski John B Method for establishing a sterilizing dose for radiation sensitive products
EP2208482A1 (fr) * 2007-10-12 2010-07-21 Microport Medical (Shanghai) Co., Ltd. Stent artificiel et procédé de préparation dudit stent

Also Published As

Publication number Publication date
DE102011051692A1 (de) 2013-01-10
EP2729186A1 (fr) 2014-05-14
WO2013007584A8 (fr) 2013-04-11

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