Virus Filtration and Flow Variation: An Approach To Evaluate Any Potential Impact on Virus Retention

References

1. 1.↵
   PDA. Virus Filtration. PDA J. Pharm. Sci. Technol. 2008, 62 (S4), 28.

   OpenUrl
2. 2.↵
   1. Bolton G.,
   2. Cabatingan M.,
   3. Rubino M.,
   4. Lute S.,
   5. Brorson K.,
   6. Bailey M.

   Normal-Flow Virus Filtration: Detection and Assessment of the Endpoint in Bioprocessing. Biotechnol. Appl. Biochem. 2005, 42 (2), 133–142.

   OpenUrlPubMed
3. 3.↵
   1. Willkommen H.,
   2. Blumel J.,
   3. Brorson K.,
   4. Chen D.,
   5. Chen Q.,
   6. Groner A.,
   7. Kreil T.R.,
   8. Robertson J. S.,
   9. Ruffing M.,
   10. Ruiz S.

   Meeting Report—Workshop on Virus Removal by Filtration: Trends and New Developments. PDA J. Pharm. Sci. Technol. 2013, 67 (2), 98–104.

   OpenUrlAbstract/FREE Full Text
4. 4.↵
   1. Lute S.

   Virus filtration breakthrough risks and mitigation strategies PDA/FDA Virus and TSE Safety Conference, Washington, DC, June 9–11, 2014.
5. 5.↵
   European Medicines Agency. CPMP Note for Guidance on Virus Validation Studies: The Design, Contribution and Interpretation of Studies Validating the Inactivation and Removal of Viruses (CPMP/BWP/268/95/rev). CPMP/BWP/268/95/rev. 1996.
6. 6.↵
   1. Furuya K.,
   2. Murai K.,
   3. Yokoyama T.,
   4. Maeno H.,
   5. Takeda Y.,
   6. Murozuka T.,
   7. Wakisaka A.,
   8. Tanifuji M.,
   9. Tomono T.

   Implementation of a 20-nm Pore-Size Filter in the Plasma-Derived Factor VIII Manufacturing Process. Vox Sang. 2006, 91 (2), 119–125.

   OpenUrlPubMed
7. 7.↵
   1. Wieser A.,
   2. Berting A.,
   3. Medek C.,
   4. Poelsler G.,
   5. Kreil T. R.

   The Evolution of Down-Scale Virus Filtration Equipment for Virus Clearance Studies. Biotechnol. Bioeng. 2015, 112 (3), 633–637.

   OpenUrl
8. 8.↵
   1. Gruber F.,
   2. Falkner F. G.,
   3. Dorner F.,
   4. Hämmerle T.

   Precise Quantitation of Human Parvovirus B19 DNA in Biological Samples by PCR. Biologicals 1998, 26 (3), 213–216.

   OpenUrlCrossRefPubMed
9. 9.↵
   1. Adan-Kubo O. J.

   Virus Removal is Affected by Flux, Brownian Motion of Virus and Virus-Membrane Interaction. 17th Planova workshop, Washington, DC, June 12–13, 2014.
10. 10.↵
    1. Hongo-Hirasaki T.

    , Process Designing for Virus Removal Filtration, 17th Planova workshop, Washington, DC, June 12–13, 2014.