Retrospective Evaluation of Low-pH Viral Inactivation and Viral Filtration Data from a Multiple Company Collaboration

References

1. 1.↵
   1. Anderson Kevin P.,
   2. Low M.-A.,
   3. Lie Y. S.,
   4. Keller G.-A.,
   5. Dinowitz M.

   Endogenous Origin of Defective Retrovirus-Like Particles from a Recombinant Chinese Hamster Ovary Cell Line. Virology 1991, 181 (1), 305–311.

   OpenUrlPubMed
2. 2.↵
   1. Garnick R. L.

   Raw Materials as a Source of Contamination in Large Scale Cell Culture. Dev. Biol. Stand. 1998, 93, 21–29.

   OpenUrlPubMedWeb of Science
3. 3.↵
   1. Nims R. W.

   Detection of Adventitious Viruses in Biologicals—a Rare Occurrence. Dev. Biol. (Basel) 2006, 123, 153–164.

   OpenUrlPubMed
4. 4.↵
   U.S. Food and Drug Administration (FDA). Points to Consider in the Manufacture and Testing of Monoclonal Antibodies for Human Use. Docket No. 94D-0259. FDA: Rockville, MD, 1997.
5. 5.↵
   EMEA. “Guideline on Virus Safety Evaluation of Biotechnology Investigational Medicinal Products.” Doc. Ref. EMEA/CHMP/BWP/398498/2005. London, UK: European Medicines Agency, 2008.
6. 6.↵
   ICH. “Guidance on Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin, Q5A.” International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. Geneva, Switzerland, 1998.
7. 7.↵
   EMEA. “Note for Guidance on Virus Validation Studies: The Design, Contribution and Interpretation of Studies Validating the Inactivation and Removal of Viruses.” Doc. Ref. CPMP/BWP/268/95. London, UK: European Medicines Agency, 1996.
8. 8.↵
   ICH. “Quality Risk Management, Q9.” International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. Geneva, Switzerland, 2005.
9. 9.↵
   1. Ishihara T.,
   2. Kadoya T.

   Accelerated Purification Process Development of Monoclonal Antibodies for Shortening Time to Clinic: Design and Case Study of Chromatography Processes. J. Chromatogr., A 2007, 1176 (1–2), 149–156.

   OpenUrlPubMed
10. 10.↵
    ASTM E2888–12, Standard Practice for Process for Inactivation of Rodent Retrovirus by pH, ASTM International, West Conshohocken, PA, 2012, www.astm.org.http://www.astm.org/
11. 11.↵
    1. Aranha H.,
    2. Bailey M.,
    3. Bender J.,
    4. Carter J.,
    5. Chen Q.,
    6. Dowd C.,
    7. Jani R.,
    8. Jen D.,
    9. Kidd S.,
    10. Meltzer T.,
    11. Remington K.,
    12. Rice I.,
    13. Romero C.,
    14. Sato T.,
    15. Jornitz M.,
    16. Sekura C. M.,
    17. Sofer G.,
    18. Specht R.,
    19. Wojciechowski P.

    1. Brorson K.,
    2. Lute S.,
    3. Hague M.,
    4. Martin J.,
    5. Sato T.,
    6. Moroe I.,
    7. Morgan M.,
    8. Krishnan M.,
    9. Campbell J.,
    10. Genest P.,
    11. Parella J.,
    12. Dolan S.,
    13. Martin S.,
    14. Tarrach K.,
    15. Levy R.

    ; PDA Virus Filter Task Force; Aranha H., Bailey M., Bender J., Carter J., Chen Q., Dowd C., Jani R., Jen D., Kidd S., Meltzer T., Remington K., Rice I., Romero C., Sato T., Jornitz M., Sekura C. M., Sofer G., Specht R., Wojciechowski P. A Consensus Rating Method for Small Virus-Retentive Filters. I. Method Development. PDA J. Pharm. Sci. Technol. 2008, 62 (5), 318–333.

    OpenUrlAbstract/FREE Full Text
12. 12.↵
    1. Miesegaes G.,
    2. Lute S.,
    3. Brorson K.

    Analysis of Viral Clearance Unit Operations for Monoclonal Antibodies. Biotechnol. Bioengin. 2010, 106 (2), 238–246.

    OpenUrlPubMed
13. 13.↵
    1. Tsujimoto K.,
    2. Uozaki M.,
    3. Ikeda K.,
    4. Yamazaki H.,
    5. Utsunomiya H.,
    6. Ichinose M.,
    7. Koyama A. H.,
    8. Arakawa T.

    Solvent-Induced Virus Inactivation by Acidic Arginine Solution. Int. J. Mol. Med. 2010, 25 (3), 433–437.

    OpenUrlPubMed
14. 14.↵
    1. LaCasse D.,
    2. Genest P.,
    3. Pizzelli K.,
    4. Greenhalgh P.,
    5. Mullin L.,
    6. Slocum A.

    Impact of Process Interruption on Virus Retention of Small-Virus Filters. Bioprocess International 2013, 11 (10), 34–44.

    OpenUrl
15. 15.↵
    1. Lute S.,
    2. Bailey M.,
    3. Combs J.,
    4. Sukumar M.,
    5. Brorson K.

    Phase Passage after Extended Processing in Small-Virus-Retentive Filters. Biotechnol. Appl. Biochem. 2007, 47 (3), 141–151.

    OpenUrlPubMed
16. 16.↵
    1. Edwards J.,
    2. Mann E.,
    3. Brown D. T.

    Conformational Changes in Sindbis Virus Envelope Proteins Accompanying Exposure to Low pH. J. Virol. 1983, 45 (3), 1090–1097.

    OpenUrlAbstract/FREE Full Text
17. 17.↵
    1. Brorson K.,
    2. Krejci S.,
    3. Lee K.,
    4. Hamilton E.,
    5. Stein K.,
    6. Xu Y.

    Bracketed Generic Inactivation of Rodent Retroviruses by Low pH Treatment for Monoclonal Antibodies and Recombinant Proteins. Biotechnol. Bioeng. 2003, 82 (3), 321–329.

    OpenUrlCrossRefPubMed
18. 18.↵
    1. Stuckey J.,
    2. Strauss D.,
    3. Venkiteshwaran A.,
    4. Gao J.,
    5. Luo W.,
    6. Quertinmont M.,
    7. O'Donnell S.,
    8. Chen D.

    A Novel Approach to Achieving Modular Retrovirus Clearance for a Parvovirus Filter. Biotechnol. Prog. 2014, 30 (1), 79–85.

    OpenUrl
19. 19.↵
    1. Gefroh E.,
    2. Dehghani H.,
    3. McClure M.,
    4. Connell-Crowley L.,
    5. Vedantham G.

    Use of MMV as a Single Worst-Case Model Virus in Viral Filter Validation Studies. PDA J. Pharm. Sci. Technol. 2015, 68, (3), 297–311.

    OpenUrl