PDA Journal of Pharmaceutical Science and Technology: 64 (5)

September/October 2010; Volume 64,Issue 5

Editor's Note

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Cell Substrates: PDA Journal Special Issue
Govind Rao

PDA Journal of Pharmaceutical Science and Technology September 2010, 64 (5) 373;

Conference Proceeding

Introduction to Workshop
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  Introduction: PDA Cell Substrate Workshop Proceedings
  Kathryn King, Michael Wiebe and ; on behalf of the Cell Substrate Task Force
  
  PDA Journal of Pharmaceutical Science and Technology September 2010, 64 (5) 374;
Keynote Address
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  Animal Cell Substrates: Back to the Future
  John Petricciani
  
  PDA Journal of Pharmaceutical Science and Technology September 2010, 64 (5) 375-378;
New Cell Lines
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  Lentiviral Vector–Mediated Genetic Modification of Cell Substrates for the Manufacture of Proteins and Other Biologics
  Lajos Baranyi, Andre Roy, Heather D. Embree and Boro Dropulic
  
  PDA Journal of Pharmaceutical Science and Technology September 2010, 64 (5) 379-385;
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  Application of Lentiviral Vectors for Development of Production Cell Lines and Safety Testing of Lentiviral-Derived Cells or Products
  Cherylene Plewa
  
  PDA Journal of Pharmaceutical Science and Technology September 2010, 64 (5) 386-391;
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  Experiences with HEK293: A Human Cell Line
  Michael J Rubino
  
  PDA Journal of Pharmaceutical Science and Technology September 2010, 64 (5) 392-395;
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  Safety Testing and Use of Insect Cells for Recombinant Protein Production
  Penny L. Post
  
  PDA Journal of Pharmaceutical Science and Technology September 2010, 64 (5) 396-418;
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  The Avian EB66® Cell Line, Application to Vaccines, and Therapeutic Protein Production
  Stephen W. Brown and Majid Mehtali
  
  PDA Journal of Pharmaceutical Science and Technology September 2010, 64 (5) 419-425;
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  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;
Raw Materials
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  Gamma-Irradiation of Serum for the Inactivation of Adventitious Contaminants
  Gay Gauvin and Raymond Nims
  
  PDA Journal of Pharmaceutical Science and Technology September 2010, 64 (5) 432-435;
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  Viral Risk Mitigation for Mammalian Cell Culture Media
  Bob Weaver and Scott Rosenthal
  
  PDA Journal of Pharmaceutical Science and Technology September 2010, 64 (5) 436-439;
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  Raw Materials Case Histories
  Michael J. Rubino
  
  PDA Journal of Pharmaceutical Science and Technology September 2010, 64 (5) 440-441;
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  TSE Case Studies Associated with Japanese and Other Regulatory Authorities—Talk Transcript
  Barbara J. Potts
  
  PDA Journal of Pharmaceutical Science and Technology September 2010, 64 (5) 442-444;
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  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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  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;
Virus Testing
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  Rapid Molecular Assays for Microbial Contaminant Monitoring in the Bioprocess Industry
  Rangarajan Sampath, Lawrence B. Blyn and David J. Ecker
  
  PDA Journal of Pharmaceutical Science and Technology September 2010, 64 (5) 458-464;
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  Root Cause Investigation of Unusual Results Experienced during Master Cell Bank (MCB) Testing and Characterization
  Dayue Chen and Christopher C. Hatfield
  
  PDA Journal of Pharmaceutical Science and Technology September 2010, 64 (5) 465-470;
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  Apparent Virus Contamination in Biopharmaceutical Product at Centocor
  Linda C. Hendricks, Jarrat Jordan, Tong-Yuan Yang, Paul Driesprong, Gert Jan Haan, Mareike Viebahn, Thomas Mikosch, Henri Van Drunen and Anthony S. Lubiniecki
  
  PDA Journal of Pharmaceutical Science and Technology September 2010, 64 (5) 471-480;
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  Adventitious Viruses Detected in Biopharmaceutical Bulk Harvest Samples over a 10 Year Period
  Andrew Kerr and Raymond Nims
  
  PDA Journal of Pharmaceutical Science and Technology September 2010, 64 (5) 481-485;
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  Regulatory Expectations of Validation/Qualification of Adventitious Virus Assays
  S. A. Baylis and J. BlÜmel
  
  PDA Journal of Pharmaceutical Science and Technology September 2010, 64 (5) 486-491;
Synthesis Session Summary
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  Synthesis Session
  Michael Wiebe, Kathryn King and ; on behalf of the Cell Substrate Task Force
  
  PDA Journal of Pharmaceutical Science and Technology September 2010, 64 (5) 492-494;

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Table of Contents

Editor's Note

Conference Proceeding

Introduction to Workshop

Keynote Address

New Cell Lines

Raw Materials

Virus Testing

Synthesis Session Summary

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Parenteral Drug Association, Inc.