Proceedings of the 2017 Viral Clearance Symposium, Session 3: Resin Lifetime

Reference

1. 1.↵
   International Conference on Harmonisation (ICH). Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin; Q5A(R1); International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use: Geneva, Switzerland, 1999.
2. 2.↵
   1. Blümel J.,
   2. Brorson K.

   Session 2: Company-specific data on cycled resin testing. PDA J. Pharm. Sci. Technol 2016, 70 (5), 428–442.

   OpenUrlFREE Full Text
3. 3.↵
   1. Brorson K.,
   2. Brown J.,
   3. Hamilton E.,
   4. Stein E.

   Identification of Protein A media performance attributes that can be monitored as surrogates for retrovirus clearance during extended re-use. J. Chromatogr. A 2003, 989 (1), 155–163.

   OpenUrlPubMed
4. 4.↵
   1. Lute S.,
   2. Norling L.,
   3. Hanson M.,
   4. Emery R.,
   5. Stinson D.,
   6. Padua K.,
   7. Blank G.,
   8. Chen Q.,
   9. Brorson K.

   Robustness of virus removal by Protein A chromatography is independent of media lifetime. J. Chromatogr. A 2008, 1205 (1–2), 17–25.

   OpenUrlPubMed
5. 5.↵
   1. Norling L.,
   2. Lute S.,
   3. Emery R.,
   4. Khuu W.,
   5. Voisard M.,
   6. Xu Y.,
   7. Chen Q.,
   8. Blank G.,
   9. Brorson K.

   Impact of multiple re-use of anion-exchange chromatography media on virus removal. J. Chromatogr. A 2005, 1069 (1), 79–89.

   OpenUrlPubMed
6. 6.↵
   1. Kelley B. D.,
   2. Jakubik J.,
   3. Vicik S.

   Viral clearance studies on new and used chromatography resins: critical review of a large dataset. Biologicals 2008, 36 (2), 88–98.

   OpenUrlPubMed
7. 7.↵
   1. Miesegaes G.,
   2. Bailey M.,
   3. Willkommen H.,
   4. Chen Q.,
   5. Roush D.,
   6. Blumel J.,
   7. Brorson K.

   Protein A chromatography (7–22). Proceedings of the 2009 Viral Clearance Symposium, Indianapolis, IN, Mar 20–21, 2009.
8. 8.↵
   1. Miesegaes G.,
   2. Lute S.,
   3. Brorson K.

   Analysis of viral clearance unit operations for monoclonal antibodies. Biotechnol. Bioeng 2010, 106 (2), 238–246.

   OpenUrlPubMed
9. 9.↵
   European Medicines Agency. Presented at the Joint Biologics Working Party/Quality Working Party Workshop with stakeholders in relation to prior knowledge and its use in regulatory applications, London, UK, November 23, 2017.