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EP-3519484-B1 - COMPOSITIONS ON PLASMA-TREATED SURFACES

EP3519484B1EP 3519484 B1EP3519484 B1EP 3519484B1EP-3519484-B1

Inventors

  • KNIGHT, BYRON J.
  • OPALSKY, DAVID

Dates

Publication Date
20260506
Application Date
20170929

Claims (20)

  1. A method of preparing a solid composition adhered to a plasma-treated surface, wherein the plasma-treated surface is the interior surface of a plasma-treated vessel, and forming a mixture from the solid composition, the method comprising drying a solution on the plasma-treated surface and forming a solid composition from the solution, the solid composition being adhered to the plasma-treated surface, wherein the solution comprises one or more enzymes, and wherein the solid composition does not refer to a coating, the solid composition being in the form of a lyophilized pellet adhered to the plasma-treated surface; and forming a reconstituted composition by combining a reconstitution liquid and the solid composition to form the mixture, wherein the reconstitution liquid comprises at least one of water, a polar organic solvent, and a nonpolar organic solvent, and wherein reconstituted means that the solid composition is completely solubilized.
  2. The method of claim 1, wherein the plasma-treated surface is a surface treated with cold cathode discharge, hollow cathode discharge, radio frequency (RF)- induced discharge, corona discharge, glow discharge, or charged particle beam.
  3. The method of claim 2, wherein the method comprises preparing the plasma-treated surface by treating the surface with a corona discharge at a watt density ranging from 25 watt/min/m 2 to 2000 watt/min/m 2 50 watt/min/m 2 to 1500 watt/min/ m 2 , 100 to 1200 watt/min/m 2 , 200 to 1000 watt/min/m 2 , 100 to 600 watt/min/m 2 , or 200 watt/min/m 2 to 600 watt/min/m 2 , or wherein the surface was treated with a corona discharge at a watt density ranging from 25 watt/min/m 2 to 2000 watt/min/m 2 , 50 watt/min/m 2 to 1500 watt/min/m 2 , 100 to 1200 watt/min/m 2 , 200 to 1000 watt/min/m 2 , 100 to 600 watt/min/m 2 , or 200 watt/min/m 2 to 600 watt/min/m 2 .
  4. The method of any one of claims 1 to 3, wherein the plasma-treated surface is a surface comprising a polyolefin and has a contact angle of 5° to 50°.,
  5. The method of any one of claims 1 to 4, wherein the plasma-treated surface is a surface comprising a polyolefin and has a surface energy from 33 to 45 dynes/cm.
  6. The method of any one of claims 1 to 4, wherein the plasma-treated surface is a surface comprising a polyethylene or polypropylene and has a surface energy from 35 to 55 dynes/cm.
  7. The method of any one of the claims 1 to 6, wherein the solid composition is macroscopic in three orthogonal dimensions and has a length, a width, and a height of greater than 1 mm.
  8. The method of any one of the claims 1 to 7, wherein the solid composition is reconstituted at a reconstitution time under 60 sec after the reconstitution liquid, which is an aqueous solution suitable for use of the solid composition, is contacted with the solid composition, and wherein the time at which a substance is determined to be reconstituted is the time at which the substance is completely solubilized.
  9. The method of any one of the preceding claims, wherein the solution comprises a buffer.
  10. The method of claim 9, wherein the buffer is an organic buffer.
  11. The method of any one of the preceding claims, wherein the solution has an inorganic salt concentration of 5 mM or less.
  12. The method of any one of the preceding claims, wherein the solution is free of inorganic salt.
  13. The method of any one of the preceding claims, wherein the solution comprises a salt.
  14. The method of any one of the preceding claims, wherein the solution comprises at least one oligonucleotide useful for performing a molecular assay.
  15. The method of claim 14, wherein the at least one oligonucleotide is selected from an amplification oligomer and a probe.
  16. The method of claim 14 or 15, wherein the oligonucleotide comprises a label.
  17. The method of claim 16, wherein the label is a fluorescent, chemiluminescent, affinity, or radioactive label.
  18. The method of any one of the preceding claims, wherein the solution comprises one or more nucleoside triphosphates.
  19. The method of claim 18, wherein the solution comprises one or more deoxynucleoside triphosphates.
  20. The method of claim 19, wherein the solution comprises dATP, dGTP, dCTP, and at least one of dTTP and dUTP.

Description

INTRODUCTION AND SUMMARY Solid compositions do not necessarily adhere strongly to surfaces. Lack of sufficient adhesion can be a problem in areas such as providing solid pharmaceutical compositions or reagents for performing chemical, pharmaceutical, or biochemical reactions or assays, in that the composition may become dislocated or loose during shipment or handling. Dislocated or loose compositions may complicate or prevent reconstitution, such as where a fixed volume of reconstitution liquid is dispensed in an instrument and some or all of the composition is no longer adhered at or near the bottom of the vessel in which reconstitution occurs. Failure to completely reconstitute the composition into a liquid state can adversely affect assay performance. US 2002/173016 A1 discloses high throughput lyophilized polymerase devices and methods for their use in the production of nucleic acids using template dependent polymerase reactions. US 2009/011488 A1 discloses methods for storing a composition useful for synthesizing nucleic acid molecules. WO 2010/144682 A1 discloses formulations for dry storage of PCR reagents. WO 2014/030005 A1 discloses polymeric materials which have a bioflavonoid coating. US 2008/241549 A1 discloses a method for forming a conductive polymer film, the method comprising coating a mixed solution of a binder and an oxidant on a transparent substrate; synthesizing a conductive polymer by vapor-phase polymerization (VPP) on the coating to form a conductive polymer film; and patterning the conductive polymer film with UV light. US 4 225 631 A discloses a process for forming an abrasion-resistant, adherent coating on a polymeric substrate formed from monomers which contain unsaturated groups, comprising forming a certain solution, applying a coating of said solution to a clean surface of the polymeric substrate, dehydrating the coated substrate at an elevated temperature; and subsequently subjecting the dehydrated coated substrate to high energy radiation until an adherent coating having significantly improved abrasion-resistance is formed thereon. US 2009/305381 A1 relates to activated polymer substrates capable of binding functional biological molecules, to polymer substrates comprising bound and functional biological molecules, to devices comprising such substrates and to methods of producing them. JP 2016067330 A relates to a production method for frozen cells which freezes cells while adhering the cells on a cell-culturing substrate. JP H03 22588 B relates to an immunoassay device made of synthetic resin, which has a number of recesses formed therein, the surfaces of which have been subjected to a low-temperature plasma treatment to improve adhesion of freeze-dried serum. Compositions, e.g., comprising bulking reagents or reagents for performing chemical or biochemical reactions or assays, are provided as solid compositions adhered to a plasma-treated surfaces. It has been found that plasma treatment of a surface can improve the adhesion to the surface of solid compositions formed by drying a liquid solution, and that plasma treatment can prevent or reduce the frequency of dislocation or loosening of solid compositions from a surface, such as the surface at or near the bottom of a vessel. Without wishing to be bound to a particular theory, plasma treatment may increase the hydrophilicity of the surface and therefore its wettability, strengthening the interaction of the reagent with the surface, and that the strengthened interaction persists following a drying process, e.g., lyophilization. The present disclosure is premised in part on the insight that the adhesion of a solid composition such as a lyophilized pellet to a surface such as a plastic can be strengthened by plasma treatment of the surface before the solid composition is in contact with the surface. Accordingly, the compositions, methods, and kits disclosed herein can provide products with improved ability to survive agitation that may occur during processes such as shipping and handling, or at least provide the public with a useful choice. Accordingly, disclosed herein is a method of preparing a solid composition adhered to a plasma-treated surface, wherein the plasma-treated surface is the interior surface of a plasma-treated vessel, and forming a mixture from the solid composition, the method comprising drying a solution on the plasma-treated surface and forming a solid composition from the solution, the solid composition being adhered to the plasma-treated surface, wherein the solution comprises one or more enzymes, and wherein the solid composition does not refer to a coating, the solid composition being in the form of a lyophilized pellet adhered to the plasma-treated surface; and forming a reconstituted composition by combining a reconstitution liquid and the solid composition to form the mixture, wherein the reconstitution liquid comprises at least one of water, a polar organic solvent, and a nonpolar organic solvent,