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Research ArticleConference Proceeding

Testing Considerations for Novel Cell Substrates: A Regulatory Perspective

A. S. Khan
PDA Journal of Pharmaceutical Science and Technology September 2010, 64 (5) 426-431;
A. S. Khan
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  • For correspondence: Arifa.Khan@fda.hhs.gov
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References

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    Code of Federal Regulations, Title 9, Animal and Animal Products (current year): Part 113.53, Requirements for ingredients of animal origin used for production of biologics. Office of the Federal Register, National Archives and Records Administration, U.S. Government Printing Office: Washington DC. January 1, 2010.
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PDA Journal of Pharmaceutical Science and Technology: 64 (5)
PDA Journal of Pharmaceutical Science and Technology
Vol. 64, Issue 5
September/October 2010
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Testing Considerations for Novel Cell Substrates: A Regulatory Perspective
A. S. Khan
PDA Journal of Pharmaceutical Science and Technology Sep 2010, 64 (5) 426-431;

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Testing Considerations for Novel Cell Substrates: A Regulatory Perspective
A. S. Khan
PDA Journal of Pharmaceutical Science and Technology Sep 2010, 64 (5) 426-431;
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  • Article
    • Abstract
    • Introduction
    • Transition in Cell Substrates
    • Safety Issues Related to Novel Cell Substrates
    • Comprehensive Safety Scheme for Cell Substrate Testing
    • General Considerations for Product Safety
    • Acknowledgments
    • References
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  • Detection of Latent Retroviruses in Vaccine-related Cell Substrates: Investigation of RT Activity Produced by Chemical Induction of Vero Cells
  • Current Testing Methods and Challenges for Detection of Adventitious Viruses
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