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;

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In This Issue
PDA Journal of Pharmaceutical Science and Technology
Vol. 64, Issue 5
September/October 2010
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;
Jump to section
- 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
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