MIT CAACB Risk Assessment Case Study: Assessing Virus Cross-Contamination Risk between Two Simultaneous Processes in an Open Biomanufacturing Facility

References

1. 1.↵
   1. Barone P. W.,
   2. Wiebe M. E.,
   3. Leung J. C.,
   4. Hussein I. T. M.,
   5. Keumurian F. J.,
   6. Bouressa J.,
   7. Brussel A.,
   8. Chen D.,
   9. Chong M.,
   10. Dehghani H.,
   11. Gerentes L.,
   12. Gilbert J.,
   13. Gold D.,
   14. Kiss R.,
   15. Kreil T. R.,
   16. Labatut R.,
   17. Li Y.,
   18. Müllberg J.,
   19. Mallet L.,
   20. Menzel C.,
   21. Moody M.,
   22. Monpoeho S.,
   23. Murphy M.,
   24. Plavsic M.,
   25. Roth N. J.,
   26. Roush D.,
   27. Ruffing M.,
   28. Schicho R.,
   29. Snyder R.,
   30. Stark D.,
   31. Zhang C.,
   32. Wolfrum J.,
   33. Sinskey A. J.,
   34. Springs S. L.

   Viral Contamination in Biologic Manufacture and Implications for Emerging Therapies. Nat. Biotechnol. 2020, 38 (5), 563–572.

   OpenUrlCrossRef
2. 2.↵
   1. Reber D.,
   2. Griffin M.

   Consortium on Adventitious Agent Contamination in Biomanufacturing (CAACB). Quality Risk Management in the Context of Viral Contamination. In Microbiological Identification and Control for the 21st Century: Strategies, Methodologies and Applications; Reber D., Griffin M., Eds.; Parenteral Drug Association: Bethesda, MD, 2018.
3. 3.↵
   1. Barone P. W.,
   2. Avgerinos S.,
   3. Ballard R.,
   4. Brussel A.,
   5. Clark P.,
   6. Dowd C.,
   7. Gerentes L.,
   8. Hart I.,
   9. Keumurian F. J.,
   10. Kindermann J.,
   11. Leung J. C.,
   12. Ly N.,
   13. Mink S.,
   14. Minning S.,
   15. Mullberg J.,
   16. Murphy M.,
   17. Nöske K.,
   18. Parriott S.,
   19. Shum B.,
   20. Wiebe M. E.,
   21. Springs S. L.

   Biopharmaceutical Industry Approaches to Facility Segregation for Viral Safety: An Effort from the Consortium on Adventitious Agent Contamination in Biomanufacturing). PDA J. Pharm. Sci. Technol. 2019, 73 (2), 191–203.

   OpenUrlAbstract/FREE Full Text
4. 4.↵
   1. Xu L.,
   2. Lee S. B.,
   3. Fuchs C.,
   4. Hyams K. C.,
   5. Brorson K.,
   6. Swann P.

   Role of Risk Assessments in Viral Safety: An FDA Perspective. PDA J. Pharm. Sci. Technol. 2014, 68 (1), 6–10.

   OpenUrlFREE Full Text