Title:
VIRAL CLEARANCE TEST METHOD
Document Type and Number:
WIPO Patent Application WO/2022/203044
Kind Code:
A1
Abstract:
A viral clearance test method that comprises: supplying a protein solution into a first channel 10, in which a protein purification part 11 is provided upstream and a virus removal filter 12 is provided downstream, and flowing the protein solution at a first constant speed to the protein purification part 11; supplying a virus solution at a second constant speed to a second channel 20, which is connected between the protein purification part 11 and the virus removal filter 12 of the first channel, and mixing the purified protein solution with the virus solution in the first channel 10; flowing the solution mixture of the protein solution with the virus solution at a third constant speed through the virus removal filter 12; and measuring the virus contained in the permeate of the solution mixture having passed through the virus removal filter 12.
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Inventors:
SHIRATAKI HIRONOBU (JP)
JUERGEN EBNER (AT)
JUERGEN EBNER (AT)
Application Number:
PCT/JP2022/014401
Publication Date:
September 29, 2022
Filing Date:
March 25, 2022
Export Citation:
Assignee:
ASAHI KASEI MEDICAL CO LTD (JP)
International Classes:
C12Q1/70; B01D65/10; B01D69/02; C12Q1/22
Domestic Patent References:
| WO2018075716A1 | 2018-04-26 | |||
| WO2014080676A1 | 2014-05-30 |
Foreign References:
| US20120088228A1 | 2012-04-12 | |||
| JP4024041B2 | 2007-12-19 |
Other References:
BIRTE KLEINDIENST, ANIKA MANZKE, PETER KOSIOL: "Continuous Processing: Challenges and Opportunities of Virus Filtration", PHARMACEUTICAL TECHNOLOGY, vol. 43, no. 1, 2 January 2019 (2019-01-02), pages 38 - 40, XP002805245
YOSHIMOTO NORIKO, ICHIHARA TAKAMITSU, YAMAMOTO SHUICHI: "Connected flow-through chromatography processes as continuous downstream processing of proteins", MATEC WEB OF CONFERENCES, vol. 268, 1 January 2019 (2019-01-01), pages 01003, XP055969912, DOI: 10.1051/matecconf/201926801003
SARAH A. JOHNSON; MATTHEW R. BROWN; SCOTT C. LUTE; KURT A. BRORSON: "Adapting viral safety assurance strategies to continuous processing of biological products", BIOTECHNOLOGY AND BIOENGINEERING, JOHN WILEY, HOBOKEN, USA, vol. 114, no. 6, 20 April 2017 (2017-04-20), Hoboken, USA, pages 1362 - 1362, XP071153347, ISSN: 0006-3592, DOI: 10.1002/bit.26245
BOHONAK DAVID M., MEHTA USHMA, WEISS ERIC R., VOYTA GREG: "Adapting virus filtration to enable intensified and continuous monoclonal antibody processing", BIOTECHNOLOGY PROGRESS, AMERICAN CHEMICAL SOCIETY, vol. 37, no. 2, 1 March 2021 (2021-03-01), XP055969924, ISSN: 8756-7938, DOI: 10.1002/btpr.3088
SHIRATAKI HIRONOBU, YOKOYAMA YOSHIRO, TANIGUCHI HIROKI, AZEYANAGI MIKU: "Analysis of filtration behavior using integrated column chromatography followed by virus filtration", BIOTECHNOLOGY AND BIOENGINEERING, JOHN WILEY, HOBOKEN, USA, vol. 118, no. 9, 1 September 2021 (2021-09-01), Hoboken, USA, pages 3569 - 3580, XP055969931, ISSN: 0006-3592, DOI: 10.1002/bit.27840
VIRUL SAFETY EVALATION OF BIOTECHNOLOGY PRODUCT DERIVED FROM CELLINE OF HUMAN OR ANIMAL ORIGIN Q5A
"Note For Guidance On Virus Validation Studies", THE DESIGN, CONTRIBUTION AND INTERPRETATION OF STUDIES VALIDATING THE INACTIVATION AND REMOVAL OF VIRUSES
"Guideline for safety guarantee of plasma fractionated product against virus", 30 August 1999, PHARMACEUTICAL AND FOOD SAFETY BUREAU
RAPHAEL WOLFISBERG ET AL., JOURNAL OF VIROLOGY, 2016
BEATRIZ MAROTO ET AL., JOURNAL OF VIROLOGY, 2004
V. HUTORNOJS, ENV, EXP., vol. 10, 2012, pages 117 - 123
ANTHONY M. D'ABRAMO JR. ET AL., VIROLOGY, 2005
JOSHUA C GRIEGER ET AL., MOLECULAR THERAPY, 2015
PAVEL PLEVKA ET AL., JOURNAL OF VIROLOGY, 2011
PETER TATTERSALL ET AL., JOURNAL OF VIROLOGY, 1976
YOSHIMOTO NORIKO, ICHIHARA TAKAMITSU, YAMAMOTO SHUICHI: "Connected flow-through chromatography processes as continuous downstream processing of proteins", MATEC WEB OF CONFERENCES, vol. 268, 1 January 2019 (2019-01-01), pages 01003, XP055969912, DOI: 10.1051/matecconf/201926801003
SARAH A. JOHNSON; MATTHEW R. BROWN; SCOTT C. LUTE; KURT A. BRORSON: "Adapting viral safety assurance strategies to continuous processing of biological products", BIOTECHNOLOGY AND BIOENGINEERING, JOHN WILEY, HOBOKEN, USA, vol. 114, no. 6, 20 April 2017 (2017-04-20), Hoboken, USA, pages 1362 - 1362, XP071153347, ISSN: 0006-3592, DOI: 10.1002/bit.26245
BOHONAK DAVID M., MEHTA USHMA, WEISS ERIC R., VOYTA GREG: "Adapting virus filtration to enable intensified and continuous monoclonal antibody processing", BIOTECHNOLOGY PROGRESS, AMERICAN CHEMICAL SOCIETY, vol. 37, no. 2, 1 March 2021 (2021-03-01), XP055969924, ISSN: 8756-7938, DOI: 10.1002/btpr.3088
SHIRATAKI HIRONOBU, YOKOYAMA YOSHIRO, TANIGUCHI HIROKI, AZEYANAGI MIKU: "Analysis of filtration behavior using integrated column chromatography followed by virus filtration", BIOTECHNOLOGY AND BIOENGINEERING, JOHN WILEY, HOBOKEN, USA, vol. 118, no. 9, 1 September 2021 (2021-09-01), Hoboken, USA, pages 3569 - 3580, XP055969931, ISSN: 0006-3592, DOI: 10.1002/bit.27840
VIRUL SAFETY EVALATION OF BIOTECHNOLOGY PRODUCT DERIVED FROM CELLINE OF HUMAN OR ANIMAL ORIGIN Q5A
"Note For Guidance On Virus Validation Studies", THE DESIGN, CONTRIBUTION AND INTERPRETATION OF STUDIES VALIDATING THE INACTIVATION AND REMOVAL OF VIRUSES
"Guideline for safety guarantee of plasma fractionated product against virus", 30 August 1999, PHARMACEUTICAL AND FOOD SAFETY BUREAU
RAPHAEL WOLFISBERG ET AL., JOURNAL OF VIROLOGY, 2016
BEATRIZ MAROTO ET AL., JOURNAL OF VIROLOGY, 2004
V. HUTORNOJS, ENV, EXP., vol. 10, 2012, pages 117 - 123
ANTHONY M. D'ABRAMO JR. ET AL., VIROLOGY, 2005
JOSHUA C GRIEGER ET AL., MOLECULAR THERAPY, 2015
PAVEL PLEVKA ET AL., JOURNAL OF VIROLOGY, 2011
PETER TATTERSALL ET AL., JOURNAL OF VIROLOGY, 1976
Attorney, Agent or Firm:
INABA, Yoshiyuki et al. (JP)
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