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1

Achieving a Successful Scale-Down Model and Optimized Economics through Parvovirus Filter Validation using Purified TrueSpikeTM Viruses.

De Vilmorin P, Slocum A, Jaber T, Schaefer O, Ruppach H, Genest P. De Vilmorin P, et al. PDA J Pharm Sci Technol. 2015 May-Jun;69(3):440-9. doi: 10.5731/pdajpst.2015.01054. PDA J Pharm Sci Technol. 2015. PMID: 26048749

2

Use of MMV as a Single Worst-Case Model Virus in Viral Filter Validation Studies.

Gefroh E, Dehghani H, McClure M, Connell-Crowley L, Vedantham G. Gefroh E, et al. PDA J Pharm Sci Technol. 2014 May-Jun;68(3):297-311. doi: 10.5731/pdajpst.2014.00978. PDA J Pharm Sci Technol. 2014. PMID: 25188350 Review.

3

Meeting report--workshop on virus removal by filtration: trends and new developments.

Willkommen H, Blümel J, Brorson K, Chen D, Chen Q, Gröner A, Kreil TR, Robertson JS, Ruffing M, Ruiz S. Willkommen H, et al. PDA J Pharm Sci Technol. 2013 Mar-Apr;67(2):98-104. doi: 10.5731/pdajpst.2013.00907. PDA J Pharm Sci Technol. 2013. PMID: 23569071

4

Limits in virus filtration capability? Impact of virus quality and spike level on virus removal with xenotropic murine leukemia virus.

Roush DJ, Myrold A, Burnham MS, And JV, Hughes JV. Roush DJ, et al. Biotechnol Prog. 2015 Jan-Feb;31(1):135-44. doi: 10.1002/btpr.2020. Epub 2014 Nov 29. Biotechnol Prog. 2015. PMID: 25395156

5

Achieving high mass-throughput of therapeutic proteins through parvovirus retentive filters.

Bolton GR, Basha J, Lacasse DP. Bolton GR, et al. Biotechnol Prog. 2010 Nov-Dec;26(6):1671-7. doi: 10.1002/btpr.494. Epub 2010 Sep 21. Biotechnol Prog. 2010. PMID: 20859931

6

Filter preconditioning enables representative scaled-down modelling of filter capacity and viral clearance by mitigating the impact of virus spike impurities.

Khan NZ, Parrella JJ, Genest PW, Colman MS. Khan NZ, et al. Biotechnol Appl Biochem. 2009 Apr;52(Pt 4):293-301. doi: 10.1042/BA20080133. Biotechnol Appl Biochem. 2009. PMID: 18844606 Free PMC article.

7

RUNspike, a complementary virus filter spiking method: a solution to the problem of reduced throughput due to the addition of the virus spike.

Parrella J, Wu Y, Kahn DW, Genest P. Parrella J, et al. PDA J Pharm Sci Technol. 2009 Nov-Dec;63(6):547-58. PDA J Pharm Sci Technol. 2009. PMID: 20169861

8

Prediction of viral filtration performance of monoclonal antibodies based on biophysical properties of feed.

Rayfield WJ, Roush DJ, Chmielowski RA, Tugcu N, Barakat S, Cheung JK. Rayfield WJ, et al. Biotechnol Prog. 2015 May-Jun;31(3):765-74. doi: 10.1002/btpr.2094. Epub 2015 May 19. Biotechnol Prog. 2015. PMID: 25919945

9

Impact of virus preparation quality on parvovirus filter performance.

Slocum A, Burnham M, Genest P, Venkiteshwaran A, Chen D, Hughes J. Slocum A, et al. Biotechnol Bioeng. 2013 Jan;110(1):229-39. doi: 10.1002/bit.24600. Epub 2012 Aug 6. Biotechnol Bioeng. 2013. PMID: 22766979

10

A novel approach to achieving modular retrovirus clearance for a parvovirus filter.

Stuckey J, Strauss D, Venkiteshwaran A, Gao J, Luo W, Quertinmont M, O'Donnell S, Chen D. Stuckey J, et al. Biotechnol Prog. 2014 Jan-Feb;30(1):79-85. doi: 10.1002/btpr.1820. Epub 2013 Oct 24. Biotechnol Prog. 2014. PMID: 24123923

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