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Research ArticleConference Proceeding

Regulatory Considerations for Raw Materials Used in Biological Products

A. S. Khan
PDA Journal of Pharmaceutical Science and Technology September 2010, 64 (5) 451-457;
A. S. Khan
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Abstract

Raw materials are critical components of product manufacture; these include source materials such as cell substrates, tissues, and biological fluids required for product manufacture, as well as biological materials required for cell growth, propagation, differentiation, and selection. Adventitious viruses are a major safety concern in biological raw materials. This paper discusses the specific concerns related to different types of biological materials and presents the Center for Biologics Evaluation and Research's perspective on the qualification and management of raw materials for purposes of developing a safety program for the manufacture of biological products.

  • Raw materials
  • Cell substrates
  • Adventitious agents
  • Product safety
  • © PDA, Inc. 2010
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In This Issue

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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Regulatory Considerations for Raw Materials Used in Biological Products
A. S. Khan
PDA Journal of Pharmaceutical Science and Technology Sep 2010, 64 (5) 451-457;

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Regulatory Considerations for Raw Materials Used in Biological Products
A. S. Khan
PDA Journal of Pharmaceutical Science and Technology Sep 2010, 64 (5) 451-457;
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  • Article
    • Abstract
    • Introduction
    • History of Virus Contaminations Due to Raw Materials
    • Safety Issues Related to Biological Raw Materials
    • Considerations for Developing a Comprehensive Testing Scheme for Product Safety
    • Qualification and Management of Raw Materials
    • Efforts toward Designing Safety in Biologics
    • Acknowledgments
    • References
  • Figures & Data
  • References
  • Info & Metrics
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Cited By...

  • A Multicenter Study To Evaluate the Performance of High-Throughput Sequencing for Virus Detection
  • Current Testing Methods and Challenges for Detection of Adventitious Viruses
  • Mouse Minute Virus (MMV) Contamination--A Case Study: Detection, Root Cause Determination, and Corrective Actions
  • Detection of Latent Retroviruses in Vaccine-related Cell Substrates: Investigation of RT Activity Produced by Chemical Induction of Vero Cells
  • Google Scholar

More in this TOC Section

Conference Proceeding

  • Proceedings of the 2017 Viral Clearance Symposium, Session 4: Submission Strategies
  • Proceedings of the 2017 Viral Clearance Symposium Session 5: Facility Risk Mitigation
  • Proceedings of the 2017 Viral Clearance Symposium: Conclusion
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Raw Materials

  • Gamma-Irradiation of Serum for the Inactivation of Adventitious Contaminants
  • Viral Risk Mitigation for Mammalian Cell Culture Media
  • Raw Materials Case Histories
Show more Raw Materials

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