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WO1997018844A1 - Procede et systeme d'inactivation utilises dans des fluides biologiques - Google Patents

Procede et systeme d'inactivation utilises dans des fluides biologiques Download PDF

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Publication number
WO1997018844A1
WO1997018844A1 PCT/US1996/019047 US9619047W WO9718844A1 WO 1997018844 A1 WO1997018844 A1 WO 1997018844A1 US 9619047 W US9619047 W US 9619047W WO 9718844 A1 WO9718844 A1 WO 9718844A1
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WO
WIPO (PCT)
Prior art keywords
fluid
photoactive agent
biological fluid
agent
plasma
Prior art date
Application number
PCT/US1996/019047
Other languages
English (en)
Inventor
Raleigh A. Carmen
Thomas J. Bormann
Frank R. Pascale
Original Assignee
Pall Corporation
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 Pall Corporation filed Critical Pall Corporation
Priority to AU10856/97A priority Critical patent/AU1085697A/en
Publication of WO1997018844A1 publication Critical patent/WO1997018844A1/fr

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Classifications

    • 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
    • A61L2/0005—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts
    • A61L2/0011—Methods 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
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/02—Blood transfusion apparatus
    • A61M1/0209—Multiple bag systems for separating or storing blood components
    • A61M1/0213—Multiple bag systems for separating or storing blood components with isolated sections of the tube used as additive reservoirs
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/02—Blood transfusion apparatus
    • A61M1/0209—Multiple bag systems for separating or storing blood components
    • A61M1/0218—Multiple bag systems for separating or storing blood components with filters
    • A61M1/0222—Multiple bag systems for separating or storing blood components with filters and filter bypass
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3681—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits by irradiation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3681—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits by irradiation
    • A61M1/3683—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits by irradiation using photoactive agents
    • A61M1/3686—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits by irradiation using photoactive agents by removing photoactive agents after irradiation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3679—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits by absorption
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2202/00—Special media to be introduced, removed or treated
    • A61M2202/04—Liquids
    • A61M2202/0413—Blood
    • A61M2202/0427—Platelets; Thrombocytes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2202/00—Special media to be introduced, removed or treated
    • A61M2202/04—Liquids
    • A61M2202/0413—Blood
    • A61M2202/0439—White blood cells; Leucocytes

Definitions

  • This invention relates to inactivation protocols, especially involving the removal of inactivating agents, such as photoactive agents, from fluids, particularly biological fluids such as blood or blood components.
  • Some protocols for inactivating potentially pathogenic material include exposing the material to light (or other forms of radiation), in the presence of an inactivating material such as psoralen or methylene blue. It is believed that these inactivating materials are photoactive, so that in the presence of light they become activated and will react with the membrane structures and/or nucleic acids of the material in such a manner that the material, e.g. , viruses and/or microorganisms such as bacteria, may be killed, or prevented from replicating.
  • an inactivating material such as psoralen or methylene blue.
  • the fluid to be treated may include components or constituents such as, for example, plasma proteins and/or leukocytes, that reduce the efficiency of inactivation, e.g. , by binding to the photoactive agent and/ or interfering with the materials' exposure to radiation. Since the material is bound, and/or fails to receive sufficient radiation, the inactivation efficiency may be reduced. As a result, it may be necessary to increase the level or concentration of inactivating material in the fluid, to attempt to overcome the interference. However, the increased level or concentration of inactivating material may have adverse effects on the desirable constituents of the fluid to be treated.
  • the period for radiation exposure may have to be extended to allow for more complete activation.
  • some fluid treatment or processing protocols include passing the inactivating material-including fluid through a filter or over a column to remove the material.
  • these filters or columns may fail to efficiently remove the inactivating material and material byproducts, particularly when an increased amount of material is used.
  • biological fluids such as blood and blood components may also contain varying numbers of white blood cells (leukocytes), which may cause undesirable effects when administered to a patient
  • leukocytes white blood cells
  • the present invention provides for ameliorating at least some of the disadvantages of the prior art inactivation protocols, particularly for treating biological fluids such as blood and blood components.
  • a biological fluid is depleted of a portion of fluid, e.g. , plasma, and an inactivating agent (such as a photoactive agent) and an additive solution are added to the biological fluid before inactivation is carried out, e.g. , by activating the inactivating agent.
  • an inactivating agent such as a photoactive agent
  • an additive solution are added to the biological fluid before inactivation is carried out, e.g. , by activating the inactivating agent.
  • the depletion of plasma and the use of the additive solution allows inactivation of viruses and/or microorganisms in the biological fluid to be efficiently carried out while reducing or minimizing the amount or concentration of inactivating agent utilized.
  • the invention also provides for the removal of the inactivating agent (and byproducts thereof) from the biological fluid combined with additive solution, preferably by passing the fluid through a inactivating agent binding filter assembly.
  • the biological fluid which has been treated to inactivate potential pathogens, and subsequently depleted of inactivating agent
  • the present invention also provides sets for processing a biological fluid to inactivate potentially pathogenic material that may be present in the biological fluid.
  • the set includes a plurality of containers, including a container suitable for holding an inactivating agent (e.g. , a photoactive agent) and an additive solution, and an inactivating agent binding filter assembly comprising an inactivating agent binding medium disposed in a housing having an inlet and an outlet and defining a fluid flow path between the inlet and the outlet and through the binding medium.
  • the set includes separate containers for the inactivating agent and the additive solution.
  • the filter assembly also includes a bypass that allows a fluid, e.g. , including inactivating agent and/or additive solution, to avoid passing through the inactivating agent binding medium.
  • the present invention is compatible with a variety of fluid treatment protocols that include the use of inactivating agents such as photoactive agents for inactivating potential pathogens such as viruses and/or bacteria. Additionally, inactivation can be carried out in a closed sterile system. In some embodiments, inactivation can be carried out as part of an automated protocol.
  • inactivating agents such as photoactive agents for inactivating potential pathogens such as viruses and/or bacteria.
  • biological fluid includes any treated or untreated fluid associated with living organisms, particularly blood, including whole blood, warm or cold blood, and stored or fresh blood; treated blood, such as blood diluted with a physiological solution, including but not limited to saline, nutrient, and/or anticoagulant solutions; one or more blood components, such as platelets suspended in plasma, platelet concentrate (PC), platelet- rich plasma (PRP), plate let- free plasma, platelet-poor plasma (PPP), plasma, packed red cells (PRC), transition zone material, buffy coat; analogous blood products derived from blood or a blood component or derived from bone marrow; red cells suspended in physiological fluid; and platelets suspended in physiological fluid.
  • the biological fluid may include leukocytes, or may be treated to remove leukocytes.
  • biological fluid refers to the components described above, and to similar blood products obtained by other means and with similar properties.
  • a photoactive agent is a material that is capable of undergoing a chemical reaction when activated by radiation, e.g. , light.
  • the photoactive agent is activated in the presence of at least one nucleic acid, i.e. , DNA and/or RNA, and the chemical reaction leads to damage and/or binding with the nucleic acid.
  • Typical photoactive agents include, but are not limited to at least one of porphyrins, and their derivatives; furocoumarins such as psoralens and their derivatives, such as 8-methoxypsoralen, 5-methoxypsoralen, 4'-aminomethyl-4,5'8-trimethylpsoralen (AMT); phthalocyanines, such as aluminum phthalocyanine; merocyanines such as MC540; and other photoactive dyes such as acridine dyes; xanthene dyes, e.g. , rose bengal and eosin Y, and thiazine dyes, such as phenothiazine dyes.
  • porphyrins and their derivatives
  • furocoumarins such as psoralens and their derivatives, such as 8-methoxypsoralen, 5-methoxypsoralen, 4'-aminomethyl-4,5'8-trimethylpsoralen (AMT)
  • the photoactive agent may comprise a drug such as a member of the family of light- activated drugs derived from benzoporphyrin. These derivatives are sometimes referred to as BPDs.
  • the photoactive dye is a thiazine dye, such as, but not limited to, at least one of thionine, toluidine blue, neutral red, and methylene blue.
  • the photoactive agent may be activated by visible light, sunlight, ultraviolet radiation, x-ray, light emitting diodes, and other forms of radiation.
  • the photoactive agent is capable of inactivating a wide variety of undesirable matter, particularly potential pathogens.
  • the photoactive agent is capable of inactivating viruses and/or microorganisms such as bacteria and protozoa.
  • Photoactive agents may be utilized individually, sequentially, or in combination.
  • One preferred photoactive agent, methylene blue, is 3,7- Bis(dimethylamino)phenothiazin-5-ium chloride, C 16 H 18 C1N 3 S.
  • Other preferred photoactive agents include, for example, at least one psoralen or psoralen derivative.
  • a photoactive agent binding medium is a medium that removes or separates photoactive agent(s) (and byproducts thereof) from a photoactive agent- including fluid.
  • a fluid including photoactive agent, biological fluid, and additive solution is placed in contact with the photoactive agent binding medium, and the medium removes the agent (and byproducts thereof) from the fluid, e.g. , by binding the agent and byproducts.
  • the binding medium has little or no effect on the fluid and/or the desirable constituent(s) or component(s) of the fluid.
  • the binding medium can remove activated photoactive agent and its byproducts from a suspension of platelets (typically also including additive solution), and the platelets remain suitable for use as a transfusion product.
  • the binding medium can remove activated photoactive agent and its byproducts from a suspension of red blood cells, and the red blood cells remain suitable for use as a transfusion product.
  • the binding medium is capable of removing the photoactive agent and/or the byproducts from fluid before and/or after activation.
  • the binding medium removes or separates photoactive agent from biological fluid after the agent has been activated.
  • the photoactive agent binding medium may be in a variety of forms, e.g. , particles, fibers, sheets.
  • the medium can be in the form of a screen, a depth filter, hollow fibers, a web, or a film.
  • the photoactive agent binding medium can comprise a porous medium, e.g., in a filter housing.
  • the photoactive binding material can comprise particles, e.g. , in a filter housing, bed, or column.
  • the photoactive agent binding medium removes or separates other types of inactivating agents, and byproducts thereof, from an inactivating agent-including fluid.
  • Other types of inactivating agents that can be removed from by the binding medium include, for example, those agents that do not require radiation for activation.
  • additive solution is a fluid, typically a synthetic fluid that is essentially free of plasma, that is compatible with a biological fluid and is usually also compatible with an inactivating agent such as a photoactive agent.
  • an inactivating agent such as a photoactive agent.
  • the additive solution comprises at least one nutrient (e.g. , glucose) and/or buffer (e.g. , bicarbonate or phosphate).
  • the nutrient can also be a buffer (e.g. , acetate).
  • the additive solution comprises at least one nutrient and a buffer in a physiological solution such as an isotonic carrier.
  • Illustrative additive solutions include saline solutions, e.g. , comprising about 0.9% saline; and solutions containing glucose and bicarbonate or phosphate in an isotonic carrier.
  • a suitable isotonic carrier is saline.
  • additive solutions for use with biological fluids including red blood cells include adenine.
  • Illustrative solutions for use with biological fluids including red blood cells include solutions such as SAGM, AS-3, AS-1 , and AS-5.
  • Illustrative solutions for use with biological fluids including platelets include, for example, those disclosed in U.S. Patent Nos. 4,447,415 and 4,695,460; as well as those disclosed in Blood, vol. 67, pp. 672-675 (1986) and British Journal of Haematology, vol. 66, pp. 233-238 (1987).
  • an additive solution is utilized to form a fluid mixture comprising plasma-depleted biological fluid, additive solution, and photoactive agent, and the photoactive agent is activated. Subsequently, essentially all of the photoactive agent (and/or byproducts thereof) is removed from the mixture, leaving additive solution combined with plasma-depleted biological fluid.
  • this additive solution/biological fluid mixture (which has been depleted of photoactive agent and/or photoactive agent byproducts) is stored for an extended period, such as several days or more. For example, an additive solution/platelet mixture may be stored for about 5 days, or more, and an additive solution/red blood cell mixture can be stored about 42 days, or more.
  • E Fluid mixture.
  • a fluid mixture comprises biological fluid (typically plasma-depleted biological fluid), at least one additive solution, and at least one inactivating agent such as a photoactive agent.
  • biological fluid typically plasma-depleted biological fluid
  • additive solution typically plasma-depleted biological fluid
  • inactivating agent such as a photoactive agent
  • a mixture can be formed once the biological fluid, the additive solution, and the photoactive agent are in the same container or conduit.
  • the mixture is formed once the fluid, solution, and agent are combined in the same container.
  • the contents of the container can be stirred or agitated.
  • Figure 1 is an embodiment of a system according to the present invention, including a plurality of containers, and an inactivating agent binding filter assembly including a bypass.
  • Figure 2 is another embodiment of a system according to the present invention including a plurality of containers, an inactivating agent binding filter assembly including a bypass, a leukocyte depletion filter assembly, and a red blood cell barrier filter assembly.
  • Figure 3 is an embodiment of an inactivating agent binding filter assembly according to the invention.
  • the inactivating agent binding medium (hereinafter referred to as the photoactive agent binding medium) 1 is capable of binding at least one inactivating agent and/or byproduct thereof when the agent (typically combined or mixed with a biological fluid and an additive solution) is placed in contact with the binding medium.
  • the binding medium provides for substantially complete removal of the photoactive agent and byproduct thereof from the biological fluid/additive solution, i.e. , the amount of photoactive agent and byproduct(s) that may be present is below the minimum detectable by conventional protocols routinely utilized in the art, including, for example, high pressure liquid chromatography (HPLC) and spectrophotometry.
  • HPLC high pressure liquid chromatography
  • the desirable components of the biological fluid which have been depleted of the inactivating agent may be efficiently recovered in an amount suitable for further use.
  • the desirable components of the biological fluid can be at least one of the following: platelets, red blood cells, plasma, plasma proteins and coagulation factors.
  • Exemplary plasma proteins and coagulation factors include fibrinogen (Factor I), prothrombin (Factor II), Factor V, Factor VII, Factor VIII, Factor IX, Factor X, Factor XI, Factor XII, plasminogen, antithrombin III, and Cl-inactivator.
  • Embodiments of the invention include recovering at least one plasma protein depleted of the photoactive agent.
  • the photoactive agent binding medium 1 comprises a porous medium, e.g. , a fibrous web or mat, or a porous film.
  • a porous medium e.g. , a fibrous web or mat, or a porous film.
  • the binding medium includes carbon fibers, preferably activated carbon fibers. Suitable carbon fibers include, for example, phenolic fibers and novoloid fibers.
  • the binding medium comprises a self-supporting porous medium including activated carbon fibers, and the activated carbon fibers are themselves porous.
  • the binding medium may have a variety of configurations, including, for example, one or more of the following: a column, a web, sheet, a cylinder, and a depth filter. Of course, in some embodiments, for example, including at least one web, the configuration may also provide for depth filtration.
  • the binding medium can have a planar configuration, or a pleated configuration. However, the medium may be formed into any geometric shape or form suitable for contacting a biological fluid. More preferably, the binding medium is in a shape or form suitable for passing a biological fluid containing at least one photoactive agent through the medium. Typically, the medium is disposed in a housing to provide a filter assembly. A variety of suitable housings are known in the art.
  • the medium may include two or more layers and/or media. Layers and/or media may be fibrous and/or membranous. Layers and/or media may provide prefiltration, support and/or better drainage.
  • the binding medium may comprise layers and/or media each having a different pore structure.
  • the medium 1 may be arranged within a container such as a flexible blood bag.
  • the photoactive agent binding medium 1 is arranged within a housing to form a filter assembly or device 100.
  • filter assembly 100 comprises a housing having a first portion 102 including an inlet 106, and a second portion 101 including an outlet 105, and defining a fluid flow path between the inlet and the outlet, with the photoactive agent binding medium arranged across the flow path between the inlet 106 and the outlet 105.
  • the filter assembly is capable of allowing bidirectional fluid flow therethrough.
  • fluid can flow from a first container through the assembly 100 (through inlet 106, medium 1, and then outlet 105) into a second container, and from the second container through the assembly into the first container (through outlet 105, medium 1 , and then inlet 106).
  • the inlet can also be an outlet, and the outlet can also be an inlet.
  • assembly 100 may also include a bypass 2, such as a conduit, that allows fluid to avoid passing through photoactive binding medium 1.
  • a bypass 2 such as a conduit
  • photoactive agent binding assembly 100 includes a bypass 2, with the bypass 2 being in fluid communication with inlet 106 and outlet 105 via connector 13 and conduit 120, and connector 12 and conduit 110, which are respectively below and above assembly 100.
  • inlet 106 will function as an outlet
  • outlet 105 will function as an inlet.
  • Flow control devices 7 such as clamps, valves, and the like, may be used to control the flow through the bypass 2 or through the medium 1, as desired.
  • a flow control device such as a clamp or valve can be in or on bypass 2
  • additional flow control devices can be in or on conduits 110 and/or 120. Selectively opening and closing the flow control devices allows fluid to flow in the desired direction through the bypass 2 or the medium 1.
  • Biological fluid, with or without inactivating agent (e.g. , photoactive agent) and/or additive fluid may be collected, recovered and/or stored in at least one container, such as containers 5, 10, 15, 20 and 25 as illustrated in Figures 1 and 2.
  • the containers 5, 10, 15, 20 and 25 are commercially available blood collection and/or satellite bags.
  • at least one container is transparent to allow the contents of the container (e.g. , biological fluid and photoactive agent) to be more efficiently exposed to radiation.
  • the container utilized to allow the contents to be exposed to radiation comprises a plastic material such as poly (ethylene-vinyl acetate) (EVA).
  • conduits e.g. , conduits 110, 120, 130, 140, 150, 160, 170, 180, 190, 210 and 220 and connectors, e.g. , connectors 12, 13, 14, and 16.
  • conduits e.g. , conduits 110, 120, 130, 140, 150, 160, 170, 180, 190, 210 and 220 and connectors, e.g. , connectors 12, 13, 14, and 16.
  • connectors e.g. , connectors 12, 13, 14, and 16.
  • a variety of conduits and connectors can be utilized.
  • commercially available flexible tubing and connectors e.g. , as used in conventional blood processing systems, are suitable for use in the invention.
  • conduits 110, 120, 130, 140, and 150, and connectors 12, 13, and 14 provide fluid communication with photoactive agent binding filter device 100, interposed between containers 5, 10 and 15.
  • At least one conduit and/or container may have at least one inactivating agent contained therein.
  • at least one conduit may include at least one photoactive agent, e.g. , sealed between a first end and a second end of the conduit.
  • at least one container may contain at least one photoactive agent.
  • the conduit and/or container may be steam sterilizable.
  • a steam sterilizable conduit and/or container may comprise a non- PVC plastic material, e.g. , at least one of polypropylene, styrene-ethylene-butylene- styrene (SEBS), poly(ethylene-vinyl acetate) (EVA), polyester, and polyurethane.
  • SEBS styrene-ethylene-butylene- styrene
  • EVA poly(ethylene-vinyl acetate)
  • a system 200 in accordance with the present invention includes a photoactive agent binding medium 1, at least one container, and at least one conduit. While the photoactive agent binding medium 1 may be located within a container such as a blood bag, in a more preferred embodiment, the medium 1 is positioned in a housing to provide a filter assembly 100, as illustrated in Figure 3, and as described above.
  • a preferred system according to the invention includes a plurality of containers, conduits, connectors, and a filter assembly 100 in fluid communication with at least two containers.
  • the system illustrated in Figure 1 includes three containers, 5, 10, and 15, conduits 110, 120, 130, 140, 150, and 160; connectors 12, 13, and 14; and photoactive agent filter assembly 100 comprising photoactive agent binding medium 1 positioned in a housing.
  • the illustrated system also includes a plurality of flow control devices 7 such as clamps or valves.
  • the system includes additional devices such as at least one leukocyte filter device and/or at least one red cell barrier filter device.
  • the system illustrated in Figure 2 has some components as described with respect to Figure 1 (like components have like reference numbers), and also includes leukocyte filter device 21 ; and leukocyte filter device, red cell barrier filter device, or combined red cell barrier filter/leukocyte depletion device 11.
  • Illustrative leukocyte filter devices and/or red cell barrier filter devices include those disclosed in, for example, U.S. Patent Nos. 4,880,548; 4,925,572; 5, 152,905; and 5,217,627; as well as International Publication Nos. WO 93/25295 and WO 93/04763.
  • the housings disclosed in these patents and publications can also be suitable for use with a photoactive agent binding medium 1 to form an assembly 100.
  • the system illustrated in Figure 2 also includes additional containers 20 and 25, as well as conduits 170, 180, 190, 210, and 220, and connector 16.
  • the system 200 may be open or closed.
  • the system is closed.
  • the term "closed” refers to a system that allows the collection, processing, filtration, storage, and preservation of donor blood or blood components without the need to enter the system (and risk contamination of the system).
  • a closed system can be as originally made, or result from the connection of the individual (or partially connected) components of such a system using what are known as "sterile docking" devices. Illustrative sterile docking devices are disclosed in U.S. Patent No. 4,507, 119.
  • the system which may be part of system for automated processing as disclosed in, for example, International Publication WO 94/01193, is suitable for use with other devices including, for example, leukocyte filter and/or red cell barrier filter devices (as noted above), and/or gas processing devices.
  • the system may include gas processing devices such as gas inlets and/or gas outlets as disclosed in U.S. Patent Nos. 5,126,054, 5,217,627 and 5,451 ,321 ; and International Publication WO 91/17809, as well as gas collection and displacement devices as disclosed in International Publication No. WO 93/25295.
  • a portion of fluid is depleted from the biological fluid that is to be exposed to the inactivating agent(s) such as photoactive agent(s).
  • Additive solution and photoactive agent are mixed with the plasma-depleted biological fluid to produce a fluid mixture.
  • the method can include depleting the majority of the plasma from the biological fluid, and replacing most, if not all, of this volume of plasma with an equivalent volume of additive solution and inactivating agent.
  • inactivating agent can be mixed with the biological fluid along with the additive solution to form a fluid mixture, or the inactivating agent and additive solution can be added separately to form the mixture. After the fluid mixture is formed, the inactivating agent is typically activated.
  • a photoactive agent can be exposed to radiation.
  • the photoactive agent and/or byproducts thereof are subsequently removed from the fluid mixture, e.g., by contacting a photoactive agent binding medium with the photoactive agent and/or byproducts.
  • the fluid mixture can be passed through a porous photoactive agent binding medium, to deplete the fluid mixture of photoactive agent and byproducts.
  • the fluid that passes through the medium which is depleted of photoactive agent and agent byproduct(s), is recovered for later use.
  • the desirable components of the biological fluid which have been depleted of the photoactive agent and byproducts are efficiently recovered in an amount suitable for further use.
  • the recovered photoactive agent depleted biological fluid is suitable for further processing or treatment, e.g. , fractionation and/or administration to a patient.
  • the desirable components of the biological fluid can be at least one of the following: platelets, red blood cells, plasma, plasma proteins and coagulation factors.
  • Exemplary plasma proteins and coagulation factors include fibrinogen (Factor I), prothrombin (Factor II), Factor V, Factor VII, Factor VIII, Factor IX, Factor X, Factor XI, Factor XII, plasminogen, antithrombin III, and Cl-inactivator.
  • Embodiments of the invention include recovering at least one plasma protein depleted of the photoactive agent.
  • Preferred plasma proteins and coagulation factors that can be recovered in accordance with the invention include prothrombin, fibrinogen, and Factor X. In some embodiments, for example, involving the processing of a platelet- containing fluid mixture, the mixture is placed in contact with the photoactive agent binding medium, and the photoactive agent is bound.
  • the additive solution containing biological fluid, depleted of photoactive agent and its byproducts, is recovered, to provide platelets suitable for transfusion.
  • a plurality of platelet-containing fluid mixtures are processed as described above, and the recovered platelets are pooled before transfusion.
  • a unit of biological fluid can be held in container 15, and additive solution combined with inactivating agent can be held in container 5.
  • flow control devices 7 are initially closed.
  • components of the biological fluid in container 15 can be concentrated according to their differences in specific gravities.
  • the container 15, holding a unit of biological fluid can be centrifuged to separate components of the biological fluid by differential sedimentation. A portion of plasma can be depleted from the biological fluid in container 15, and passed through conduit 150 to container 10. If desired, conduit 150 can be subsequently clamped and/or heat sealed.
  • the additive solution/inactivating agent can be passed from container 5 to container 15 through the bypass 2, and mixed with the plasma -depleted biological fluid to form the fluid mixture.
  • the flow control devices 7 associated with bypass 2 and conduit 130 can be opened, to allow the passage of additive solution/inactivating agent into container 15.
  • the inactivating agent is a photoactive agent
  • the fluid mixture in the container 15 which is typically in a transparent container, is exposed to radiation, e.g., light, to activate the agent.
  • the photoactive agent and its byproducts are then separated from the biological fluid/additive solution by placing the mixture in contact with the photoactive agent binding medium 1.
  • the medium 1 is arranged within a housing to form a filter assembly 100 as illustrated in Figure 3, and used in a system such as that illustrated in Figure 1
  • the photoactive agent and byproducts are separated by passing the mixture from container 15 along a fluid flow path from the inlet 106 through the photoactive agent binding medium 1 and the outlet 105 into container 5.
  • flow control device 7 associated with bypass 2 can be opened, to allow fluid to flow from container 15 and through medium 1 (in assembly 100) into container 5.
  • the fluid mixture is formed in container 15.
  • the fluid mixture could be formed in container 5, and the photoactive agent and byproducts can be separated by passing the mixture from container 5 through assembly 100 into container 15.
  • the mixture can be formed in any of the containers, and then passed through a photoactive agent binding medium 1 and into any container that is suitable for holding fluid depleted of photoactive agent(s) and byproducts thereof.
  • a variety of additive solutions may be used in accordance with the invention, as long as the solutions are compatible with the biological fluid and the inactivating agent(s).
  • the additive solution can be mixed with the inactivating agent and then mixed with the biological fluid, or the additive solution can be mixed with the plasma depleted biological fluid before adding the inactivating agent. Accordingly, in a variation of the system according to Figure 1, additive solution, inactivating agent, and biological fluid, can be held in separate containers, to allow any combination of fluids before forming the fluid mixture.
  • biological fluid can be combined with additive solution, and passed in one direction tlirough photoactive agent binding medium into a container of photoactive agent to form the fluid mixture. After the fluid mixture is formed, the mixture can be passed in the other direction through the photoactive agent binding medium into a container that is suitable for holding fluid depleted of photoactive agent(s) and byproducts thereof.
  • a biological fluid can be collected in container 25.
  • a biological fluid such as whole blood is collected in container 25, and centrifuged to form a supernatant layer of platelet-rich- plasma, and a sediment layer of concentrated red cells.
  • the supernatant layer can be passed from container 25 into container 15.
  • a filter device 11 comprising a leukocyte filter device, red cell barrier filter device, or a combined red cell barrier filter/leukocyte depletion device, is inte ⁇ osed between container 25 and container 15.
  • the supernatant layer collected in container 15 is depleted of leukocytes and is essentially free of red blood cells.
  • This supernatant layer in container 15 can be further processed as described earlier, e.g. , with reference to Figure 1.
  • the concentrated red blood cells in container 25 can be further processed.
  • an additive or storage solution, e.g. , in container 20 can be passed into container 25, or the red blood cells can be passed into container 20, and the red blood cells can be stored for later use.
  • die red blood cells are depleted of leukocytes, e.g. , by passing the red blood cells through a leukocyte depletion filter device.
  • a leukocyte depletion filter device 21 can be interposed between containers 25 and 20 to allow the red blood cells to be leukocyte depleted and passed into container 20.
  • Protocols for treating fluid with at least one inactivating agent are known in the art, and the invention is not to be limited thereby.
  • Illustrative protocols for contacting the fluid with photoactive agent include adding at least one photoactive agent to the biological fluid/additive solution, or by placing photoactive agent in a container and then passing the biological fluid/additive solution into the container.
  • the photoactive agent utilized, and other parameters e.g. , concentration of the agent, the amount of contact time before exposure to radiation) will depend upon the biological fluid to be treated and the characteristics of the photoactive agent used, as is known in the art.
  • any biological fluid can be processed according to the invention.
  • components of the biological fluid e.g. , red blood cells or platelets
  • a portion of plasma can be removed from whole blood and replaced with additive solution, and photoactive agent can be added to form a mixture.
  • photoactive agent can be added to form a mixture.
  • the red blood cells can be separated from the platelets.
  • whole blood can be processed to separate platelets from red blood cells, and a portion of plasma can be removed from the red blood cell and/or platelet suspensions.
  • Additive solution and photoactive agent can be added to either or both suspensions to form mixtures, which can be subsequently processed as described above.
  • the fluid mixture i.e. , containing photoactive agent, biological fluid and additive solution, is exposed to radiation according to exposure protocols that are known in the art. Accordingly, the radiation source, the band of radiation utilized, and other parameters (e.g. , radiation intensity, length of exposure period) will depend upon the biological fluid to be treated and the characteristics of the photoactive agent used.
  • the fluid mixture is subsequently depleted of photoactive agent and byproducts as described previously, e.g. , by placing the photoactive agent and byproducts in contact with a photoactive agent binding medium.
  • the fluid mixture is depleted of photoactive agent as it is passed through a photoactive agent binding device.
  • a mixture containing the photoactive agent methylene blue is passed through the binding device at a flow rate in the range of from about 5 ml/min to about
  • the flow rate is in the range from about 10 ml/min to about 80 ml/min.
  • the inactivating agent-depleted fluid may be washed, filtered, and/or stored, before further use. If desired, at least some of the additive solution can be removed from the inactivating agent-depleted fluid before further use.
  • leukocytes are removed from the fluid mixture or the biological fluid. For example, leukocytes may be removed before, after, or while passing the fluid mixture through the photoactive agent binding medium. Leukocytes can be removed from biological fluid before or after depleting plasma therefrom.
  • leukocyte depletion is accomplished by passing the biological fluid, or fluid mixture, through a leukocyte depletion medium, more preferably, a fibrous leukocyte depletion medium.
  • a leukocyte depletion medium more preferably, a fibrous leukocyte depletion medium.
  • Illustrative leukocyte depletion media which are typically positioned in housings to form leukocyte depletion filter devices (e.g., devices 11 and 21 as described above), are disclosed in the U.S. Patents and International Publications referenced above.
  • the photoactive agent binding medium includes two or more layers, wherein at least one layer includes activated carbon fibers, and at least one layer includes a leukocyte depletion medium, so that the fluid passing through the medium may be depleted both of leukocytes and a photoactive agent such as methylene blue.
  • the photoactive agent binding medium includes a layer of activated carbon fibers inte ⁇ osed between layers of leukocyte depletion media.
  • a layer of activated carbon fibers inte ⁇ osed between layers of leukocyte depletion media may provide for prefiltration (e.g. , removal of microaggregates before the fluid contacts the carbon) as well as removal of photoactive agent and leukocytes. This configuration may also prevent carbon fines from passing through the photoactive agent binding device.
  • the system may include at least one photoactive agent in a container or conduit, the blood, or at least one blood component, may be exposed to the photoactive agent at any desired point during processing. Since the conduits and containers are preferably transparent, the photoactive agent may be activated when desired.
  • air or gas may be present and/or fluid may be trapped or retained in various elements of the processing system. It may be desirable to minimize the presence of air or gas and/or to maximize the recovery of the retained biological fluid. Accordingly, at least one of a gas inlet, gas outlet, and a gas collection and displacement loop as disclosed in, for example, U.S. Patent Nos. 5, 126,054, 5,217,627 and 5,451,321; and International Publication Nos. WO 91/17809, and WO 93/25295, may be used to separate gas from the biological fluid and/or to recover biological fluid trapped or retained in various elements of the system.
  • the photoactive agent may be placed in contact with the binding medium by, for example, placing the medium (e.g. , without a housing) in a container including biological fluid and the photoactive agent.
  • the fluid need not be passed along a defined fluid flow path through the binding medium to place the agent in contact with the binding medium and thereby bind the agent.
  • handling the container e.g. , transporting, inverting and/or rocking the container, may cause additional fluid and agent to contact the binding medium, and additional agent may be bound. Accordingly, once the biological fluid and the binding medium are separated from one another, e.g.
  • biological fluid including inactivating agent is placed in contact with the photoactive agent binding material more than once.
  • biological fluid including photoactive agent may be recirculated through the system to remove or deplete additional photoactive agent upon repeated contact with the binding medium.
  • the biological fluid including photoactive agent may be repeatedly passed unidirectionally thorough the photoactive agent binding filter assembly.
  • the fluid can be passed bidirectionally therethrough, e.g. , from inlet to outlet and outlet to inlet.

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Abstract

Cette invention se rapporte à des procédés et à des systèmes pour inactiver des agents pathogènes potentiels dans des fluides biologiques, tels que du sang ou des constituants du sang, par exemple en ajoutant des agents de photoactivation et en séparant ces agents après photoactivation.
PCT/US1996/019047 1995-11-21 1996-11-15 Procede et systeme d'inactivation utilises dans des fluides biologiques WO1997018844A1 (fr)

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AU10856/97A AU1085697A (en) 1995-11-21 1996-11-15 Inactivation method and system in biological fluids

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US56162195A 1995-11-21 1995-11-21
US08/561,621 1995-11-21

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EP0933090A1 (fr) * 1998-01-30 1999-08-04 Maco Pharma International GmbH Système de poches de sang pour l'inactivation de pathogènes dans le sang, les composants sanguins et le plasma
US6270952B1 (en) 1998-01-06 2001-08-07 Cerus Corporation Methods for quenching pathogen inactivators in biological materials
US20010018179A1 (en) 1998-01-06 2001-08-30 Derek J. Hei Batch devices for the reduction of compounds from biological compositions containing cells and methods of use
FR2817152A1 (fr) * 2000-11-29 2002-05-31 Maco Pharma Sa Systeme a poches et procede pour l'inactivation virale d'un fluide prealablement deleucocyte
US6951713B2 (en) 1997-01-06 2005-10-04 Cerus Corporation Absorbing pathogen-inactivating compounds with porous particles immobilized in a matrix
US6986867B2 (en) 1999-06-03 2006-01-17 Baxter International Inc. Apparatus, systems and methods for processing and treating a biological fluid with light
US7049110B2 (en) 1998-07-21 2006-05-23 Gambro, Inc. Inactivation of West Nile virus and malaria using photosensitizers
US7068361B2 (en) 1999-06-03 2006-06-27 Baxter International Apparatus, systems and methods for processing and treating a biological fluid with light
DE102005035528A1 (de) * 2005-07-26 2007-02-01 Heim Medizintechnik Gmbh Dampfsterilisierbare Bluttrennvorrichtung
US7220747B2 (en) 1999-07-20 2007-05-22 Gambro, Inc. Method for preventing damage to or rejuvenating a cellular blood component using mitochondrial enhancer
EP1064071A4 (fr) * 1998-03-20 2007-11-21 Hemerus Medical Llc Procede et appareil de filtration d'un fluide biologique
EP1972354A1 (fr) * 2007-03-20 2008-09-24 CaridianBCT Biotechnologies, LLC Procédés et systèmes pour la préparation de produits sanguins
US7498156B2 (en) 1998-07-21 2009-03-03 Caridianbct Biotechnologies, Llc Use of visible light at wavelengths of 500 to 550 nm to reduce the number of pathogens in blood and blood components
US7611831B2 (en) 1998-01-06 2009-11-03 Cerus Corporation Adsorbing pathogen-inactivating compounds with porous particles immobilized in a matrix
US7655392B2 (en) 2004-10-29 2010-02-02 Cerus Corporation Quenching methods for red blood cell inactivation process
EP1450716A4 (fr) * 2001-12-05 2010-11-10 Fenwal Inc Procede et systemes de preparation de produits sanguins
US8900805B2 (en) 2008-04-09 2014-12-02 Cerus Corporation Quenching methods for red blood cell pathogen inactivation
US9044523B2 (en) * 2000-06-15 2015-06-02 Terumo Bct, Inc. Reduction of contaminants in blood and blood products using photosensitizers and peak wavelengths of light
CN105705177A (zh) * 2013-11-08 2016-06-22 艾克塞拉医疗公司 使用吸附介质诊断感染性疾病的方法

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US6951713B2 (en) 1997-01-06 2005-10-04 Cerus Corporation Absorbing pathogen-inactivating compounds with porous particles immobilized in a matrix
US7037642B2 (en) 1997-01-06 2006-05-02 Cerus Corporation Removing compounds from blood products with porous particles immobilized in a matrix
US9259525B2 (en) 1998-01-06 2016-02-16 Cerus Corporation Adsorbing pathogen-inactivating compounds with porous particles immobilized in a matrix
US6709810B2 (en) 1998-01-06 2004-03-23 Cerus Corporation Methods for quenching pathogen inactivators in biological materials
US20010018179A1 (en) 1998-01-06 2001-08-30 Derek J. Hei Batch devices for the reduction of compounds from biological compositions containing cells and methods of use
US6270952B1 (en) 1998-01-06 2001-08-07 Cerus Corporation Methods for quenching pathogen inactivators in biological materials
US7611831B2 (en) 1998-01-06 2009-11-03 Cerus Corporation Adsorbing pathogen-inactivating compounds with porous particles immobilized in a matrix
US7293985B2 (en) 1998-01-06 2007-11-13 Cerus Corporation Methods for quenching pathogen inactivators in biological materials
EP0933090A1 (fr) * 1998-01-30 1999-08-04 Maco Pharma International GmbH Système de poches de sang pour l'inactivation de pathogènes dans le sang, les composants sanguins et le plasma
EP1064071A4 (fr) * 1998-03-20 2007-11-21 Hemerus Medical Llc Procede et appareil de filtration d'un fluide biologique
JP2011067656A (ja) * 1998-03-20 2011-04-07 Hemerus Medical Llc 液体濾過システム
JP2008114068A (ja) * 1998-03-20 2008-05-22 Hemerus Medical Llc 液体濾過システム
US7049110B2 (en) 1998-07-21 2006-05-23 Gambro, Inc. Inactivation of West Nile virus and malaria using photosensitizers
US7498156B2 (en) 1998-07-21 2009-03-03 Caridianbct Biotechnologies, Llc Use of visible light at wavelengths of 500 to 550 nm to reduce the number of pathogens in blood and blood components
US6986867B2 (en) 1999-06-03 2006-01-17 Baxter International Inc. Apparatus, systems and methods for processing and treating a biological fluid with light
US7459695B2 (en) 1999-06-03 2008-12-02 Fenwal, Inc. Apparatus, and systems for processing and treating a biological fluid with light
US7601298B2 (en) 1999-06-03 2009-10-13 Fenwal, Inc. Method for processing and treating a biological fluid with light
US7068361B2 (en) 1999-06-03 2006-06-27 Baxter International Apparatus, systems and methods for processing and treating a biological fluid with light
US7220747B2 (en) 1999-07-20 2007-05-22 Gambro, Inc. Method for preventing damage to or rejuvenating a cellular blood component using mitochondrial enhancer
US9044523B2 (en) * 2000-06-15 2015-06-02 Terumo Bct, Inc. Reduction of contaminants in blood and blood products using photosensitizers and peak wavelengths of light
FR2817152A1 (fr) * 2000-11-29 2002-05-31 Maco Pharma Sa Systeme a poches et procede pour l'inactivation virale d'un fluide prealablement deleucocyte
WO2002043790A1 (fr) * 2000-11-29 2002-06-06 Maco Pharma Systeme a poches et procede pour l'inactivation virale d'un fluide prealablement deleucocyte
EP1450716A4 (fr) * 2001-12-05 2010-11-10 Fenwal Inc Procede et systemes de preparation de produits sanguins
US7655392B2 (en) 2004-10-29 2010-02-02 Cerus Corporation Quenching methods for red blood cell inactivation process
DE102005035528A1 (de) * 2005-07-26 2007-02-01 Heim Medizintechnik Gmbh Dampfsterilisierbare Bluttrennvorrichtung
EP1972354A1 (fr) * 2007-03-20 2008-09-24 CaridianBCT Biotechnologies, LLC Procédés et systèmes pour la préparation de produits sanguins
US8900805B2 (en) 2008-04-09 2014-12-02 Cerus Corporation Quenching methods for red blood cell pathogen inactivation
US9713627B2 (en) 2008-04-09 2017-07-25 Cerus Corporation Pathogen-inactivated red blood cell compositions
US10357516B2 (en) 2008-04-09 2019-07-23 Cerus Corporation Pathogen-inactivated red blood cell compositions
CN105705177A (zh) * 2013-11-08 2016-06-22 艾克塞拉医疗公司 使用吸附介质诊断感染性疾病的方法

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