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Research ArticleConference Proceeding

Raw Materials in the Manufacture of Biotechnology Products: Regulatory Considerations

Ruth Cordoba-Rodriguez
PDA Journal of Pharmaceutical Science and Technology September 2010, 64 (5) 445-450;
Ruth Cordoba-Rodriguez
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Article Information

vol. 64 no. 5 445-450
PubMed 
21502051

Published By 
Parenteral Drug Association (PDA)
Print ISSN 
1079-7440
Online ISSN 
1948-2124
History 
  • Published online October 12, 2010.

Copyright & Usage 
© PDA, Inc. 2010

Author Information

  1. Ruth Cordoba-Rodriguez
  1. Division of Monoclonal Antibodies, Office of Biotechnology Products, Center for Drug Evaluation and Research, Food and Drug Administration (FDA)
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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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Raw Materials in the Manufacture of Biotechnology Products: Regulatory Considerations
Ruth Cordoba-Rodriguez
PDA Journal of Pharmaceutical Science and Technology Sep 2010, 64 (5) 445-450;

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Raw Materials in the Manufacture of Biotechnology Products: Regulatory Considerations
Ruth Cordoba-Rodriguez
PDA Journal of Pharmaceutical Science and Technology Sep 2010, 64 (5) 445-450;
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  • Article
    • Abstract
    • Introduction
    • Raw Materials Can Affect Product Quality, Safety, and Efficacy
    • Raw Materials in the Use of Cell Substrates
    • Raw Materials Need To Be Appropriately Controlled
    • Risk-Based Raw Materials Management
    • Risk Identification, Risk Analysis, and Risk Evaluation
    • Conclusions
    • Disclaimer
    • Acknowledgments
    • References
  • Figures & Data
  • References
  • Info & Metrics
  • PDF

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  • Proceedings of the 2017 Viral Clearance Symposium, Session 1.1: Upstream Mitigation, Part 1—Cell Bank and Bulk Harvest Testing
  • Proceedings of the 2017 Viral Clearance Symposium, Session 6: Ensuring Viral Safety in Continuous Processing
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Raw Materials

  • Gamma-Irradiation of Serum for the Inactivation of Adventitious Contaminants
  • Viral Risk Mitigation for Mammalian Cell Culture Media
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