WO2001087357A3 - Gamma irradiation of protein-based pharmaceutical products - Google Patents

Gamma irradiation of protein-based pharmaceutical products Download PDF

Info

Publication number
WO2001087357A3
WO2001087357A3 PCT/US2001/015864 US0115864W WO0187357A3 WO 2001087357 A3 WO2001087357 A3 WO 2001087357A3 US 0115864 W US0115864 W US 0115864W WO 0187357 A3 WO0187357 A3 WO 0187357A3
Authority
WO
WIPO (PCT)
Prior art keywords
protein
pharmaceutical products
gamma irradiation
based pharmaceutical
gamma radiation
Prior art date
Legal status (The legal status 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 status listed.)
Ceased
Application number
PCT/US2001/015864
Other languages
French (fr)
Other versions
WO2001087357A2 (en
Inventor
William Drohan
Shirley Miekka
Thomas Busby
Annemarie Ralston
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
American National Red Cross
Original Assignee
American National Red Cross
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 American National Red Cross filed Critical American National Red Cross
Priority to AU2001263200A priority Critical patent/AU2001263200A1/en
Priority to EP01937464A priority patent/EP1286706A2/en
Publication of WO2001087357A2 publication Critical patent/WO2001087357A2/en
Publication of WO2001087357A3 publication Critical patent/WO2001087357A3/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

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—Disinfection or sterilisation of materials or objects, in general; Accessories therefor
    • A61L2/02—Disinfection or sterilisation of materials or objects, in general; Accessories therefor using physical processes
    • A61L2/08—Radiation
    • A61L2/081—Gamma radiation
    • 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
    • A61L2103/00—Materials or objects being the target of disinfection or sterilisation
    • A61L2103/05—Living organisms or biological materials
    • 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
    • A61L2103/00—Materials or objects being the target of disinfection or sterilisation
    • A61L2103/05—Living organisms or biological materials
    • A61L2103/09—Blood or products thereof
    • 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
    • A61L2202/00—Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
    • A61L2202/10—Apparatus features
    • A61L2202/12—Apparatus for isolating biocidal substances from the environment
    • A61L2202/122—Chambers for sterilisation

Landscapes

  • Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Micro-Organisms Or Cultivation Processes Thereof (AREA)
  • Peptides Or Proteins (AREA)

Abstract

Methods are disclosed for inactivation of microbial contaminants in proteinaceous materials while preserving the activity of the materials. The proteinaceous material is exposed to gamma radiation at a high dose rate (e.g., ⊃ 3 kiloGray/hour) while in a lyophilized state under conditions which preserve activity of the material. The material may be formulated to contain one or more stabilizers, and/or be lyophlized to a low moisture content (e.g., less than 1.5%) prior to exposure to the gamma radiation.
PCT/US2001/015864 2000-05-17 2001-05-16 Gamma irradiation of protein-based pharmaceutical products Ceased WO2001087357A2 (en)

Priority Applications (2)

Application Number Priority Date Filing Date Title
AU2001263200A AU2001263200A1 (en) 2000-05-17 2001-05-16 Gamma irradiation of protein-based pharmaceutical products
EP01937464A EP1286706A2 (en) 2000-05-17 2001-05-16 Gamma irradiation of protein-based pharmaceutical products

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US20467700P 2000-05-17 2000-05-17
US60/204,677 2000-05-17

Publications (2)

Publication Number Publication Date
WO2001087357A2 WO2001087357A2 (en) 2001-11-22
WO2001087357A3 true WO2001087357A3 (en) 2002-03-28

Family

ID=22758957

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2001/015864 Ceased WO2001087357A2 (en) 2000-05-17 2001-05-16 Gamma irradiation of protein-based pharmaceutical products

Country Status (3)

Country Link
EP (1) EP1286706A2 (en)
AU (1) AU2001263200A1 (en)
WO (1) WO2001087357A2 (en)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102154465B (en) * 2011-01-10 2013-03-13 中国人民解放军第二军医大学 Screening method of composite cerebrin-containing red flower

Families Citing this family (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6749851B2 (en) * 2001-08-31 2004-06-15 Clearant, Inc. Methods for sterilizing preparations of digestive enzymes
CN101189030A (en) * 2005-06-02 2008-05-28 阿尔扎公司 Methods for Terminal Sterilization of Transdermal Delivery Devices
EP2087109A2 (en) * 2006-09-08 2009-08-12 Promethean Lifesciences, Inc. Stabilization of biological materials through inactivation of metalloenzymes
US20160252434A1 (en) * 2014-04-16 2016-09-01 General Electric Company Gamma sterilized dextran solutions and methods of use
UA112970C2 (en) * 2010-08-05 2016-11-25 Мерк Шарп Енд Доме Корп. INITIATED WINDOW ISLAND VIRUS, METHOD OF ITS RECEIVING AND APPLICATION
CN107449925A (en) * 2017-09-22 2017-12-08 郑州大学第附属医院 A kind of buffer solution and detection method for suppressing analyte detection for blood coagulation factor VIII
JP7110360B2 (en) 2017-10-09 2022-08-01 テルモ ビーシーティー バイオテクノロジーズ，エルエルシー Freeze-drying method
CN113614477B (en) 2019-03-14 2023-04-28 泰尔茂比司特生物技术有限公司 Freeze-drying loading tray assembly and system
CN111154710A (en) * 2020-03-06 2020-05-15 兰州荣晔生物科技有限责任公司 Bovine serum freezing high-dose irradiation method

Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4620908A (en) * 1983-10-03 1986-11-04 Biocell Laboratories, Inc. Method for destroying microbial contamination in protein materials
WO1990000907A1 (en) * 1988-07-20 1990-02-08 Salford University Business Services Limited Sterilising methods
US5362442A (en) * 1993-07-22 1994-11-08 2920913 Canada Inc. Method for sterilizing products with gamma radiation
WO1994028120A1 (en) * 1991-05-10 1994-12-08 New York Blood Center, Inc. Process for the sterilization of biological compositions and the product produced thereby
WO1997017435A1 (en) * 1995-11-09 1997-05-15 Bristol-Myers Squibb Company Stable biotinylated biomolecule composition and methods
US5730933A (en) * 1996-04-16 1998-03-24 Depuy Orthopaedics, Inc. Radiation sterilization of biologically active compounds
WO1998031403A1 (en) * 1997-01-16 1998-07-23 Cohesion Corporation Lyophilized collagen-based biomaterials, process of preparation and uses thereof
WO2001070279A1 (en) * 2000-03-23 2001-09-27 Clearant, Inc. Methods for sterilizing biological materials

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4620908A (en) * 1983-10-03 1986-11-04 Biocell Laboratories, Inc. Method for destroying microbial contamination in protein materials
WO1990000907A1 (en) * 1988-07-20 1990-02-08 Salford University Business Services Limited Sterilising methods
WO1994028120A1 (en) * 1991-05-10 1994-12-08 New York Blood Center, Inc. Process for the sterilization of biological compositions and the product produced thereby
US5362442A (en) * 1993-07-22 1994-11-08 2920913 Canada Inc. Method for sterilizing products with gamma radiation
WO1997017435A1 (en) * 1995-11-09 1997-05-15 Bristol-Myers Squibb Company Stable biotinylated biomolecule composition and methods
US5730933A (en) * 1996-04-16 1998-03-24 Depuy Orthopaedics, Inc. Radiation sterilization of biologically active compounds
WO1998031403A1 (en) * 1997-01-16 1998-07-23 Cohesion Corporation Lyophilized collagen-based biomaterials, process of preparation and uses thereof
WO2001070279A1 (en) * 2000-03-23 2001-09-27 Clearant, Inc. Methods for sterilizing biological materials

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
MIEKKA S I ET AL: "New Methods for inactivation of lipid-enveloped and non-enveloped viruses", HAEMOPHILIA, vol. 4, 1998, pages 402 - 408, XP001051050 *
REID B D: "The Sterways Process: a new approach to inactivating viruses using gamma radiation", BIOLOGICALS, vol. 26, no. 2, pages 125 - 130, XP001058190 *

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102154465B (en) * 2011-01-10 2013-03-13 中国人民解放军第二军医大学 Screening method of composite cerebrin-containing red flower

Also Published As

Publication number Publication date
EP1286706A2 (en) 2003-03-05
WO2001087357A2 (en) 2001-11-22
AU2001263200A1 (en) 2001-11-26

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