Session 4.1: Case Studies of Application of Generic Claims and QbD for Viral Clearance

References

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   Proceedings of the 2009 Viral Clearance Symposium. Karger, 2010.
2. 2.↵
   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; doi:10.1002/btpr.1820.

   OpenUrlCrossRef
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   Points to Consider in the Manufacture and Testing of Monoclonal Antibody Products for Human Use, 1997.
4. 4.↵
   ASTM Standard E2888. Standard Practice for Inactivation of Rodent Retrovirus by pH, 2012.
5. 5.↵
   PDA Technical Report No. 41.