Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/15—Devices for taking samples of blood
  • A61B5/150007—Details
  • A61B5/150015—Source of blood
  • A61B5/150022—Source of blood for capillary blood or interstitial fluid
• • G—PHYSICS
  • G01—MEASURING; TESTING
  • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
  • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
  • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
  • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
  • G01N33/68—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
  • G01N33/6863—Cytokines, i.e. immune system proteins modifying a biological response such as cell growth proliferation or differentiation, e.g. TNF, CNF, GM-CSF, lymphotoxin, MIF or their receptors
  • G01N33/6869—Interleukin
• • A—HUMAN NECESSITIES
  • A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
  • A01N—PRESERVATION OF BODIES OF HUMANS OR ANIMALS OR PLANTS OR PARTS THEREOF; BIOCIDES, e.g. AS DISINFECTANTS, AS PESTICIDES OR AS HERBICIDES; PEST REPELLANTS OR ATTRACTANTS; PLANT GROWTH REGULATORS
  • A01N1/00—Preservation of bodies of humans or animals, or parts thereof
  • A01N1/10—Preservation of living parts
  • A01N1/12—Chemical aspects of preservation
  • A01N1/122—Preservation or perfusion media
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/15—Devices for taking samples of blood
  • A61B5/150007—Details
  • A61B5/150015—Source of blood
  • A61B5/150038—Source of blood for blood from umbilical cord
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/15—Devices for taking samples of blood
  • A61B5/150007—Details
  • A61B5/150015—Source of blood
  • A61B5/150045—Source of blood for blood from vagina, placenta, colon or mouth
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/15—Devices for taking samples of blood
  • A61B5/150007—Details
  • A61B5/150358—Strips for collecting blood, e.g. absorbent
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/15—Devices for taking samples of blood
  • A61B5/150007—Details
  • A61B5/150755—Blood sample preparation for further analysis, e.g. by separating blood components or by mixing
• • G—PHYSICS
  • G01—MEASURING; TESTING
  • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
  • G01N1/00—Sampling; Preparing specimens for investigation
  • G01N1/28—Preparing specimens for investigation including physical details of (bio-)chemical methods covered elsewhere, e.g. G01N33/50, C12Q
  • G01N1/2813—Producing thin layers of samples on a substrate, e.g. smearing, spinning-on
• • G—PHYSICS
  • G01—MEASURING; TESTING
  • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
  • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
  • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
  • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
  • G01N33/52—Use of compounds or compositions for colorimetric, spectrophotometric or fluorometric investigation, e.g. use of reagent paper and including single- and multilayer analytical elements
• • G—PHYSICS
  • G01—MEASURING; TESTING
  • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
  • G01N1/00—Sampling; Preparing specimens for investigation
  • G01N1/28—Preparing specimens for investigation including physical details of (bio-)chemical methods covered elsewhere, e.g. G01N33/50, C12Q
  • G01N1/2813—Producing thin layers of samples on a substrate, e.g. smearing, spinning-on
  • G01N2001/2826—Collecting by adsorption or absorption
• • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
  • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
  • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
  • Y10T436/00—Chemistry: analytical and immunological testing
  • Y10T436/25—Chemistry: analytical and immunological testing including sample preparation
  • Y10T436/25375—Liberation or purification of sample or separation of material from a sample [e.g., filtering, centrifuging, etc.]
  • Y10T436/255—Liberation or purification of sample or separation of material from a sample [e.g., filtering, centrifuging, etc.] including use of a solid sorbent, semipermeable membrane, or liquid extraction

Definitions

• the present invention relates to solid supports and is particularly concerned with solid supports which can be used in the storage, recovery and further processing of biological materials such as biopharmaceutical drugs.
• DBS 1631 S-1636S
• This novel application for collecting blood led to the population screening of newborns for the detection of treatable, inherited metabolic diseases.
• DBS have now been used for over 40 years to screen for a large range of neonatal metabolic disorders.
• DBS specimens are collected by spotting whole blood onto a solid support, such as a membrane, glass fiber or paper, either from venous blood or directly from a finger or heel prick, making this method particularly suitable for the shipment of specimens from peripheral clinics to central laboratories.
• DBS packed in zip-lock plastic bags with desiccant can be stored and shipped at ambient temperature, thus avoiding the need for i) cold chain storage and ii) fast specialized transportation.
• the consumable costs for DBS are less than US$1 per test, and transport costs are markedly reduced compared with plasma, which requires a liquid format and specialized transportation conditions (Johannessen, A., et al. , 2009; J
• biotechnologically-derived recombinant proteins, peptides and antibody-based drugs, as well as antisense oligonucleotides and DNA for gene therapy have developed into mainstream therapeutic agents and now constitute a substantial portion of the compounds under clinical development.
• These agents are commonly termed “biotech-drugs” or “biopharmaceutical drugs” to
• DMPK Drug Metabolism and Pharmacokinetic (DMPK) analysis of Biotech-drugs and low molecular weight drug compounds is important as DMPK analysis is vital to drug discovery as it provides insight into how drug candidates may be absorbed, metabolised and excreted by the body. Analyses are routinely performed at the drug discovery stage and involve dosing animals with the compound of interest, and measuring the drug (or metabolite) concentration in biological fluids as a function of time. This generates valuable information such as drug clearance, bioavailability etc, but demands a significant amount of time and resource (Beaudette, P., et al., 2004; J. of Chromatography B 809, 153-158).
• Ahlstrom grade 226 paper 1 .
• Dried blood spots as a sample collection technique for the determination of pharmacokinetics in clinical studies: considerations for the validation of a quantitative bioanalytical method.
• Solid paper supports that have the potential to be developed into devices for DMPK purposes include Munktell TFN grade, Toyo Roshi grade 545, Macherey Nagel (e.g. MN818), Reeve Angel (e.g. Double ring) and Hahnemuhle Grade 2292).
• the analyte of interest (such as endogenous proteins or Biotech drugs) must be easy to extract from the solid paper support using relatively simple techniques that are amenable to high throughput.
• solid supports which provide a simple, stable storage medium for biological materials, including i) endogenous moieties and ii) biopharmaceutical or biotech drugs, which give a high yield or recovery of the biological material on further processing.
• the present invention addresses these needs and provides methods that enhance the recovery levels of biological materials such as biopharmaceutical drugs from biological samples stored as DBS on solid supports, particularly solid paper supports. Definitions
• biomolecule is any organic molecule that is produced by a living organism, including large polymeric molecules such as proteins, polysaccharides, and nucleic acids as well as small low molecular weight molecules such as primary metabolites, secondary metabolites, and natural products.
• a synthetically-derived biomolecule is a "biomolecule" as defined in i) above that is generated using recombinant DNA technologies or chemically synthesised by other non-living in-vitro methods.
• a biopharmaceutical drug is a biotechnologically-derived recombinant protein, peptide or antibody-based drug, or an antisense
• oligonucleotide protein nucleic acid (PNA) or deoxy ribonucleic acid (DNA) for gene therapy.
• PNA protein nucleic acid
• DNA deoxy ribonucleic acid
• a cellular component is a unique, highly organized substance or substances of which cells, and thus living organisms, are composed. Examples include membranes, organelles, proteins, and nucleic acids. Whilst the majority of cellular components are located within the cell itself, some may exist in extracellular areas of an organism.
• a solid support having at least one surface coated with a chemical mixture that enhances the recovery of a biological material from the surface, wherein the chemical mixture is a mixture selected from the group consisting of vinyl polymer and non-ionic detergent, vinyl polymer and protein, non-ionic synthetic polymer and non-ionic detergent, non-ionic synthetic polymer and protein,
• PEI polyethylenemine
• non-ionic detergent non-ionic detergent and protein
• PEI polyethylenemine
• the solid support is selected from the group consisting of paper, glass microfiber and membrane.
• the support is a paper, more preferably a cellulose paper.
• the solid support is a membrane selected from the group consisting of polyester, polyether sulfone (PES), polyamide (Nylon),
• polypropylene polytetrafluoroethylene (PTFE)
• PTFE polytetrafluoroethylene
• carbonate polycarbonate
• cellulose nitrate cellulose acetate
• aluminium oxide polypropylene, polytetrafluoroethylene (PTFE), polycarbonate, cellulose nitrate, cellulose acetate and aluminium oxide.
• the vinyl polymer is polyvinyl pyrrolidone (PVP).
• the non-ionic detergent is Tween 20.
• the protein is albumin.
• the non-ionic synthetic polymer is poly-2-ethyl-2-oxazoline (PEOX).
• the chemical mixture is polyvinyl pyrrolidone (PVP) and Tween 20.
• the chemical mixture is polyvinyl pyrrolidone (PVP) and albumin.
• the chemical mixture is chemical mixture is Tween 20 and albumin.
• the chemical mixture is poly-2-ethyl-2-oxazoline (PEOX) and Tween 20.
• the chemical mixture is poly-2-ethyl-2-oxazoline PEOX and albumin.
• the chemical mixture is polyethylenemine (PEI) and Tween 20. In another aspect, the chemical mixture is polyethylenemine (PEI) and albumin.
• the support is a paper, for example a cellulose paper.
• Examples of a cellulose paper include a 903 Neonatal STD card.
• a method of recovering a biological material from a solid support comprising the steps of
• step iii) comprises storing the paper support at a temperature in the range of 15 to 40°C.
• the temperature is in the range of 20 to 30° C.
• the paper support is stored at a lower temperature depending on the thermal stability of the biological material.
• the source may be from a range of biological organisms including, but not limited to, virus, bacterium, plant and animal.
• the source will be a mammalian or a human subject.
• the sample may be selected from the group consisting of tissue, cell, blood, plasma, saliva and urine.
• the biological material is selected from the group consisting of biomolecule, synthetically- derived biomolecule, cellular component and biopharmaceutical drug.
• a method of making a solid support as hereinbefore described comprising coating at least one surface of the support with a solution of a chemical mixture that enhances the recovery of a biological material from the surface, wherein the chemical mixture is a mixture selected from the group consisting of polyvinyl pyrrolidone (PVP) and Tween 20, polyvinyl pyrrolidone (PVP) and albumin, Tween 20 and albumin, poly-2-ethyl-2-oxazoline (PEOX) and Tween 20, poly-2-ethyl-2- oxazoline PEOX and albumin, polyethylenemine (PEI) and Tween 20, and polyethylenemine (PEI) and albumin.
• PVP polyvinyl pyrrolidone
• PVP polyvinyl pyrrolidone
• PEOX poly-2-ethyl-2-oxazoline
• PEOX poly-2-ethyl-2- oxazoline
• PEOX polyethylenemine
• albumin poly
• the solid support is a paper, preferably a cellulose paper such as 903 Neonatal STD paper.
• a solid support as hereinbefore described for enhancing the recovery of a biological material from a surface thereof.
• the biological material is a biopharmaceutical drug.
• Figure 1 presents the recovery of exogenously-added IL-2 from dried blood spots applied to various paper matrices.
• Figure 2 presents the recovery of exogenously-added IL-2 from dried blood spots applied to 903 Neonatal STD papers coated with various chemicals.
• Figure 3 presents the recovery of exogenously-added IL-2 from dried blood spots applied to 903 Neonatal STD papers coated with paired combinations of chemicals.
• Poly-vinyl-pyrolodine, 1 % in water (Sigma; Cat. PVP40-100 mg, lot 1 1 pk0097).
• ⁇ - ⁇ -Trehalose 10 mg/ml (Sigma, Cat. T0299-50 mg, lot 128k1337).
• Caesin from bovine milk, 1 % in water (Sigma, Cat. C5890-500 g, lot 089k0179).
• Poly-ethylene glycol 200, 1 % in water (Fluka, Cat. 81 150, lot 1384550).
• the 903 and DMPK-C cards facilitated the recovery of 45 - 55% of the cytokine, while only 2 -3 % was recovered from the DMPK-A and B cards (see Table 1 and Figure 1 ).
• the 903 and DMPK-C cards are the basic base papers and have not been dipped or coated with any chemical, whilst the DMPK-A and B cards are coated with a proprietary mixture of chemicals that facilitate the denaturation and inactivation of proteins, micro-organisms and cells respectively.
• the DMPK-A and B cards have been designed to facilitate the storage of nucleic acids.
• the low IL-2 recovery levels observed when using the DMPK-A and B cards may actually be a reflection of the presence of these denaturing reagents and the ELISA-based antibody detection system used.
• the ELISA detection system requires the eluted IL-2 to exhibit an intact native structure.
• Table 1 The Recovery of exogenously-added IL-2 from dried blood spots applied to various paper types. The p-value compares ⁇ carrier for each paper type. The presence of the carrier had no significant effect on the recovery of IL-2 (p-value > 0.05).
• the saturation dipping of 903 Neonatal STD papers with a combination of two different chemicals indicated an additive effect in terms of the IL-2 recovery levels.
• Table 2 demonstrates that the recovery of 903 Neonatal STD papers coated with Tween 20 and Albumin are 67 % and 74 % respectively. These figures are 22% and 29% greater than the equivalent un-dipped 903 paper respectively.
• Table 3 shows the cytokine recovery when dried blood spots containing exogenously added IL-2 are applied to 903 Neonatal STD paper co- dipped with both chemicals.
• the recovery value for the Tween 20/Albumin coated paper is 92 % which represents an increase of ⁇ 40% compared to the corresponding un-dipped paper.

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• Heart & Thoracic Surgery (AREA)
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• Animal Behavior & Ethology (AREA)
• Medical Informatics (AREA)
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• General Physics & Mathematics (AREA)
• Cell Biology (AREA)
• Microbiology (AREA)
• Biotechnology (AREA)
• Food Science & Technology (AREA)
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• Investigating Or Analysing Biological Materials (AREA)
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• 2011
  • 2011-02-25 GB GBGB1103256.2A patent/GB201103256D0/en not_active Ceased
• 2012
  • 2012-02-24 CA CA2828162A patent/CA2828162C/en active Active
  • 2012-02-24 EP EP12707264.3A patent/EP2678681B1/en not_active Not-in-force
  • 2012-02-24 WO PCT/EP2012/053170 patent/WO2012113911A1/en not_active Ceased
  • 2012-02-24 JP JP2013554909A patent/JP5993382B2/ja not_active Expired - Fee Related
  • 2012-02-24 CN CN201280010246.6A patent/CN103380376B/zh not_active Expired - Fee Related
  • 2012-02-24 AU AU2012219490A patent/AU2012219490B2/en not_active Ceased
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