Table of Contents

September/October 2015; Volume 69,Issue 5

  1. Kenty, Heidi

    1. Overview of Best Practices for Biopharmaceutical Technology Transfers
      Sushil Abraham, David Bain, John Bowers, Heidi Kenty, Victor Larivee, Francisco Leira, Jasmina Xie and Jonathan Tsang
      PDA Journal of Pharmaceutical Science and Technology September 2015, 69 (5) 645-649; DOI: https://doi.org/10.5731/pdajpst.2015.01086

  2. Krause, Stephan O.

    1. PCMO L01—Setting Specifications for Biological Investigational Medicinal Products
      Stephan O. Krause
      PDA Journal of Pharmaceutical Science and Technology September 2015, 69 (5) 569-589; DOI: https://doi.org/10.5731/pdajpst.2015.01065

  3. Larivee, Victor

    1. Overview of Best Practices for Biopharmaceutical Technology Transfers
      Sushil Abraham, David Bain, John Bowers, Heidi Kenty, Victor Larivee, Francisco Leira, Jasmina Xie and Jonathan Tsang
      PDA Journal of Pharmaceutical Science and Technology September 2015, 69 (5) 645-649; DOI: https://doi.org/10.5731/pdajpst.2015.01086
    2. Strategies for Maximizing Successful Drug Substance Technology Transfer Using Engineering, Shake-Down, and Wet Test Runs
      Sushil Abraham, David Bain, John Bowers, Victor Larivee, Francisco Leira and Jasmina Xie
      PDA Journal of Pharmaceutical Science and Technology September 2015, 69 (5) 650-657; DOI: https://doi.org/10.5731/pdajpst.2015.01087

  4. Lee, Hans

    1. Creating a Holistic Extractables and Leachables (E&L) Program for Biotechnology Products
      Kim Li, Gary Rogers, Yasser Nashed-Samuel, Hans Lee, Anthony Mire-Sluis, Barry Cherney, Ronald Forster, Ping Yeh and Ingrid Markovic
      PDA Journal of Pharmaceutical Science and Technology September 2015, 69 (5) 590-619; DOI: https://doi.org/10.5731/pdajpst.2015.01073

  5. Leira, Francisco

    1. Overview of Best Practices for Biopharmaceutical Technology Transfers
      Sushil Abraham, David Bain, John Bowers, Heidi Kenty, Victor Larivee, Francisco Leira, Jasmina Xie and Jonathan Tsang
      PDA Journal of Pharmaceutical Science and Technology September 2015, 69 (5) 645-649; DOI: https://doi.org/10.5731/pdajpst.2015.01086
    2. Strategies for Maximizing Successful Drug Substance Technology Transfer Using Engineering, Shake-Down, and Wet Test Runs
      Sushil Abraham, David Bain, John Bowers, Victor Larivee, Francisco Leira and Jasmina Xie
      PDA Journal of Pharmaceutical Science and Technology September 2015, 69 (5) 650-657; DOI: https://doi.org/10.5731/pdajpst.2015.01087

  6. Li, Kim

    1. Creating a Holistic Extractables and Leachables (E&L) Program for Biotechnology Products
      Kim Li, Gary Rogers, Yasser Nashed-Samuel, Hans Lee, Anthony Mire-Sluis, Barry Cherney, Ronald Forster, Ping Yeh and Ingrid Markovic
      PDA Journal of Pharmaceutical Science and Technology September 2015, 69 (5) 590-619; DOI: https://doi.org/10.5731/pdajpst.2015.01073

  7. Markovic, Ingrid

    1. Creating a Holistic Extractables and Leachables (E&L) Program for Biotechnology Products
      Kim Li, Gary Rogers, Yasser Nashed-Samuel, Hans Lee, Anthony Mire-Sluis, Barry Cherney, Ronald Forster, Ping Yeh and Ingrid Markovic
      PDA Journal of Pharmaceutical Science and Technology September 2015, 69 (5) 590-619; DOI: https://doi.org/10.5731/pdajpst.2015.01073

  8. Martinez, Manuel

    1. Manufacturing of Plasma-Derived Medicinal Products: Qualification Process of Plasma Suppliers
      Carles Parés, Manuel Martínez, Joaquim Messeguer and Esteban Rodríguez
      PDA Journal of Pharmaceutical Science and Technology September 2015, 69 (5) 620-630; DOI: https://doi.org/10.5731/pdajpst.2015.01074

  9. Mcauley, Gerry

    1. Changing the Performance Paradigm in Pharma/Biotech: Integrating Human Performance in Global Organizations
      Amy Wilson, Michael Moedler and Gerry McAuley
      PDA Journal of Pharmaceutical Science and Technology September 2015, 69 (5) 658-665; DOI: https://doi.org/10.5731/pdajpst.2015.01088

  10. Messeguer, Joaquim

    1. Manufacturing of Plasma-Derived Medicinal Products: Qualification Process of Plasma Suppliers
      Carles Parés, Manuel Martínez, Joaquim Messeguer and Esteban Rodríguez
      PDA Journal of Pharmaceutical Science and Technology September 2015, 69 (5) 620-630; DOI: https://doi.org/10.5731/pdajpst.2015.01074
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