Meeting Report—Workshop on Virus Removal by Filtration: Trends and New Developments

Hannelore Willkommen; Johannes BlüMel; Kurt Brorson; Dayue Chen; Qi Chen; Albrecht GröNer; Thomas R. Kreil; James S. Robertson; Michael Ruffing; Sol Ruiz

doi:10.5731/pdajpst.2013.00907

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Meeting Report—Workshop on Virus Removal by Filtration: Trends and New Developments

Hannelore Willkommen, Johannes BlüMel, Kurt Brorson, Dayue Chen, Qi Chen, Albrecht GröNer, Thomas R. Kreil, James S. Robertson, Michael Ruffing and Sol Ruiz

PDA Journal of Pharmaceutical Science and Technology March 2013, 67 (2) 98-104; DOI: https://doi.org/10.5731/pdajpst.2013.00907

Hannelore Willkommen

aRegulatory Affairs & Biological Safety Consulting, Erzhausen, Germany;

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For correspondence: hannelore.willkommen@gmx.de

Johannes BlüMel

bPaul-Ehrlich Institut, Langen, Germany;

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Kurt Brorson

cCenter for Drug Evaluation and Research (CDER)/U.S. Food and Drug Administration (FDA), Silver Spring, MD, USA;

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Dayue Chen

dEli Lilly and Company, Indianapolis, IN, USA;

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Qi Chen

eGenentech Inc., South San Francisco, CA, USA;

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Albrecht GröNer

fCSL Behring GmbH, Marburg, Germany;

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Thomas R. Kreil

gBaxter BioScience, Vienna, Austria;

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James S. Robertson

hBoehringer Ingelheim Pharma GmbH&KG, Bieberach an der Riss, Germany;

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Michael Ruffing

iNational Institute for Biological Standards and Control, Potters Bar, UK; and

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Sol Ruiz

jSpanish Medicines Agency (AEMPS), Madrid, Spain

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References

1.↵
1. Asher D.,
2. Slocum A. L.,
3. Bergmann K. F.,
4. Genest P.,
5. Katz A. B.,
6. Morais J. J.,
7. Lawrence C. M.,
8. Greenhalgh P.
Predicting virus filtration performance with virus spike characterization. BioProcess Int. 2011, 9 (3), 26–37.
OpenUrl
2.↵
PDA Technical Report No. 41: Virus Filtration (2008 revision), Parenteral Drug Association: Bethesda, MD, http://www.pda.org.
3.↵
1. Lute S.,
2. Bailey M.,
3. Combs J.,
4. Sukumar M.,
5. Brorson K.
Phage passage after extended processing in small-virus-retentive filters. Biotechnol. Appl. Biochem. 2007, 47 (Pt 3), 141–151.
OpenUrl PubMed

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PDA Journal of Pharmaceutical Science and Technology

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Meeting Report—Workshop on Virus Removal by Filtration: Trends and New Developments

Hannelore Willkommen, Johannes BlüMel, Kurt Brorson, Dayue Chen, Qi Chen, Albrecht GröNer, Thomas R. Kreil, James S. Robertson, Michael Ruffing, Sol Ruiz

PDA Journal of Pharmaceutical Science and Technology Mar 2013, 67 (2) 98-104; DOI: 10.5731/pdajpst.2013.00907

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Meeting Report—Workshop on Virus Removal by Filtration: Trends and New Developments

Hannelore Willkommen, Johannes BlüMel, Kurt Brorson, Dayue Chen, Qi Chen, Albrecht GröNer, Thomas R. Kreil, James S. Robertson, Michael Ruffing, Sol Ruiz

PDA Journal of Pharmaceutical Science and Technology Mar 2013, 67 (2) 98-104; DOI: 10.5731/pdajpst.2013.00907

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Proceedings of the 2019 Viral Clearance Symposium, Session 6: Virus-Retentive Filtration
Proceedings of the 2017 Viral Clearance Symposium, Session 2.1: DSP Unit Operations--Virus Filtration/Inactivation
Viral Clearance Using Traditional, Well-Understood Unit Operations Session 1.2: Virus-Retentive Filtration
Virus Filtration and Flow Variation: An Approach To Evaluate Any Potential Impact on Virus Retention
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Use of MMV as a Single Worst-Case Model Virus in Viral Filter Validation Studies
Meeting Report--Workshop on Spike Characterizations and Virus Removal by Filtration: Trends and New Developments

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Keywords

Biopharmaceuticals
filtration
Virus removal
Virus safety

[1] 1.↵
Asher D.,
Slocum A. L.,
Bergmann K. F.,
Genest P.,
Katz A. B.,
Morais J. J.,
Lawrence C. M.,
Greenhalgh P.
Predicting virus filtration performance with virus spike characterization. BioProcess Int. 2011, 9 (3), 26–37.
OpenUrl

[2] Asher D.,

[3] Slocum A. L.,

[4] Bergmann K. F.,

[5] Genest P.,

[6] Katz A. B.,

[7] Morais J. J.,

[8] Lawrence C. M.,

[9] Greenhalgh P.

[10] 2.↵
PDA Technical Report No. 41: Virus Filtration (2008 revision), Parenteral Drug Association: Bethesda, MD, http://www.pda.org.

[11] 3.↵
Lute S.,
Bailey M.,
Combs J.,
Sukumar M.,
Brorson K.
Phage passage after extended processing in small-virus-retentive filters. Biotechnol. Appl. Biochem. 2007, 47 (Pt 3), 141–151.
OpenUrl PubMed

[12] Lute S.,

[13] Bailey M.,

[14] Combs J.,

[15] Sukumar M.,

[16] Brorson K.

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Meeting Report—Workshop on Virus Removal by Filtration: Trends and New Developments

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Parenteral Drug Association, Inc.