CA2252374A1 - A process for viral inactivation of lyophilized blood proteins - Google Patents

A process for viral inactivation of lyophilized blood proteins

Info

Publication number
CA2252374A1
CA2252374A1 CA002252374A CA2252374A CA2252374A1 CA 2252374 A1 CA2252374 A1 CA 2252374A1 CA 002252374 A CA002252374 A CA 002252374A CA 2252374 A CA2252374 A CA 2252374A CA 2252374 A1 CA2252374 A1 CA 2252374A1
Authority
CA
Canada
Prior art keywords
lyophilized
viral inactivation
blood proteins
cyclodextrin
lyophilized blood
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.)
Granted
Application number
CA002252374A
Other languages
French (fr)
Other versions
CA2252374C (en
Inventor
Prabir Bhattacharya
Toshiharu Motokubota
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.)
Grifols Shared Services North America Inc
Original Assignee
Alpha Therapeutic Corporation
Prabir Bhattacharya
Toshiharu Motokubota
Probitas Pharma Inc.
Grifols Inc.
Stream Merger Sub, Inc.
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=24545689&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=CA2252374(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Alpha Therapeutic Corporation, Prabir Bhattacharya, Toshiharu Motokubota, Probitas Pharma Inc., Grifols Inc., Stream Merger Sub, Inc. filed Critical Alpha Therapeutic Corporation
Publication of CA2252374A1 publication Critical patent/CA2252374A1/en
Application granted granted Critical
Publication of CA2252374C publication Critical patent/CA2252374C/en
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

Links

Classifications

    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/745—Blood coagulation or fibrinolysis factors
    • C07K14/755—Factors VIII, e.g. factor VIII C (AHF), factor VIII Ag (VWF)
    • 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
    • A61L2/0023—Heat
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K1/00—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
    • C07K1/14—Extraction; Separation; Purification
    • C07K1/30—Extraction; Separation; Purification by precipitation
    • C07K1/32—Extraction; Separation; Purification by precipitation as complexes

Abstract

A process for the viral inactivation of lyophilized blood proteins, particularly Factor VIII, by heat comprising forming a stable complex between the blood protein and a cyclodextrin in an aqueous solution. The solution is then lyophilized and the blood protein/cyclodextrin complex is recovered. The lyophilized blood protein/cyclodextrin is then heated, e.g., to 80 °C for 72 hours, to inactivate any virus present.
The material may then be reconstituted prior to administration to a patient.
CA002252374A 1996-04-19 1997-04-17 A process for viral inactivation of lyophilized blood proteins Expired - Lifetime CA2252374C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US63492196A 1996-04-19 1996-04-19
US08/634,921 1996-04-19
PCT/US1997/006585 WO1997039761A1 (en) 1996-04-19 1997-04-17 A process for viral inactivation of lyophilized blood proteins

Publications (2)

Publication Number Publication Date
CA2252374A1 true CA2252374A1 (en) 1997-10-30
CA2252374C CA2252374C (en) 2007-08-07

Family

ID=24545689

Family Applications (1)

Application Number Title Priority Date Filing Date
CA002252374A Expired - Lifetime CA2252374C (en) 1996-04-19 1997-04-17 A process for viral inactivation of lyophilized blood proteins

Country Status (8)

Country Link
US (1) US6566504B2 (en)
EP (1) EP0954326B2 (en)
JP (1) JP2000509374A (en)
AT (1) ATE298582T1 (en)
CA (1) CA2252374C (en)
DE (1) DE69733664T3 (en)
ES (1) ES2243994T5 (en)
WO (1) WO1997039761A1 (en)

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US8735374B2 (en) * 2009-07-31 2014-05-27 Intelgenx Corp. Oral mucoadhesive dosage form
US10610528B2 (en) 2009-12-08 2020-04-07 Intelgenx Corp. Solid oral film dosage forms and methods for making same
US20110136815A1 (en) * 2009-12-08 2011-06-09 Horst Zerbe Solid oral film dosage forms and methods for making same
US7989593B1 (en) 2010-05-27 2011-08-02 Bing Lou Wong Method for the preparation of a high-temperature stable oxygen-carrier-containing pharmaceutical composition and the use thereof
US8048856B1 (en) 2010-06-23 2011-11-01 Billion King, Ltd. Treatment methods using a heat stable oxygen carrier-containing pharmaceutical composition
US7932356B1 (en) 2010-06-23 2011-04-26 Bing Lou Wong Method for the preparation of a heat stable oxygen carrier-containing pharmaceutical composition
US8084581B1 (en) 2011-04-29 2011-12-27 Bing Lou Wong Method for removing unmodified hemoglobin from cross-linked hemoglobin solutions including polymeric hemoglobin with a high temperature short time heat treatment apparatus
US20130052232A1 (en) 2011-08-31 2013-02-28 Bing Lou Wong Method for the preparation of a heat stable oxygen carrier-containing composition facilating beta-beta cross-linking
AR107262A1 (en) * 2016-01-27 2018-04-11 Lilly Co Eli INACTIVATION OF PATHOGENS BY DELIPIDATION
CA3078625C (en) 2017-10-09 2023-01-17 Terumo Bct Biotechnologies, Llc Lyophilization container and method of using same
WO2020185909A2 (en) 2019-03-14 2020-09-17 Terumo Bct Biotechnologies, Llc Lyophilization loading tray assembly and system

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Also Published As

Publication number Publication date
US20010047085A1 (en) 2001-11-29
EP0954326A4 (en) 2002-11-20
CA2252374C (en) 2007-08-07
ATE298582T1 (en) 2005-07-15
DE69733664T3 (en) 2011-04-14
DE69733664T2 (en) 2005-12-15
WO1997039761A1 (en) 1997-10-30
EP0954326B1 (en) 2005-06-29
ES2243994T5 (en) 2009-10-29
EP0954326B2 (en) 2009-07-22
EP0954326A1 (en) 1999-11-10
ES2243994T3 (en) 2005-12-01
DE69733664D1 (en) 2005-08-04
JP2000509374A (en) 2000-07-25
US6566504B2 (en) 2003-05-20

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Legal Events

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EEER Examination request
MKEX Expiry

Effective date: 20170418