Table of Contents

March/April 2023; Volume 77,Issue 2

A

  1. Ardeshna, Hiren

    1. Evaluation of the Design, Development, and Performance of a Mass-Flow Based, Open-Source Buffer Manufacturing System
      Natraj Ram, Jeff Johnson, Hiren Ardeshna, Joseph Camire, Ryan Campbell, Doan Chau, Sam Gardner, Kevin Gibson, Joey Norikane, Paul Randolph, Kelly Smith, Katherine Stafford, Rachel Swamy, Shana Usery and Kelvin H. Lee
      PDA Journal of Pharmaceutical Science and Technology March 2023, 77 (2) 79-98; DOI: https://doi.org/10.5731/pdajpst.2021.012660

B

  1. Barone, Paul W.

    1. MIT CAACB Risk Assessment Case Study: Assessing Virus Cross-Contamination Risk between Two Simultaneous Processes in an Open Biomanufacturing Facility
      Andrea L. Koenigsberg, Veronica Fowler, Reuben Domike, Audrey Brussel, Paul W. Barone, Flora J. Keumurian, James Leung, Michael E. Wiebe, Michael T. Brewer, Shawn Chan, Nicolas Dumey, Anne Fournillier, Marcella Goodnight, Johanna Kindermann, Richard Leavy, Buyoung Lee, Stefan Minning, Marie Murphy, Eric Myers, Armen Nahabedian, Kavita Nanda, Sandi Parriott, GK Raju, Ciaran Scallan, Stephanie Schoch, Joe Shiminsky, Bonnie Shum, Sebastian Teitz, Bernice Westrek and Stacy L. Springs
      PDA Journal of Pharmaceutical Science and Technology March 2023, 77 (2) 115-132; DOI: https://doi.org/10.5731/pdajpst.2021.012691

  2. Berger, Gerd

    1. Investigating Tm Method Specificity Using Oligonucleotide Sequence Variants
      Alexandra H. Heussner, Sarina Schuler, Gerd Berger and Melanie Zerulla-Wernitz
      PDA Journal of Pharmaceutical Science and Technology March 2023, 77 (2) 67-78; DOI: https://doi.org/10.5731/pdajpst.2021.012694

  3. Brewer, Michael T.

    1. MIT CAACB Risk Assessment Case Study: Assessing Virus Cross-Contamination Risk between Two Simultaneous Processes in an Open Biomanufacturing Facility
      Andrea L. Koenigsberg, Veronica Fowler, Reuben Domike, Audrey Brussel, Paul W. Barone, Flora J. Keumurian, James Leung, Michael E. Wiebe, Michael T. Brewer, Shawn Chan, Nicolas Dumey, Anne Fournillier, Marcella Goodnight, Johanna Kindermann, Richard Leavy, Buyoung Lee, Stefan Minning, Marie Murphy, Eric Myers, Armen Nahabedian, Kavita Nanda, Sandi Parriott, GK Raju, Ciaran Scallan, Stephanie Schoch, Joe Shiminsky, Bonnie Shum, Sebastian Teitz, Bernice Westrek and Stacy L. Springs
      PDA Journal of Pharmaceutical Science and Technology March 2023, 77 (2) 115-132; DOI: https://doi.org/10.5731/pdajpst.2021.012691

  4. Brussel, Audrey

    1. MIT CAACB Risk Assessment Case Study: Assessing Virus Cross-Contamination Risk between Two Simultaneous Processes in an Open Biomanufacturing Facility
      Andrea L. Koenigsberg, Veronica Fowler, Reuben Domike, Audrey Brussel, Paul W. Barone, Flora J. Keumurian, James Leung, Michael E. Wiebe, Michael T. Brewer, Shawn Chan, Nicolas Dumey, Anne Fournillier, Marcella Goodnight, Johanna Kindermann, Richard Leavy, Buyoung Lee, Stefan Minning, Marie Murphy, Eric Myers, Armen Nahabedian, Kavita Nanda, Sandi Parriott, GK Raju, Ciaran Scallan, Stephanie Schoch, Joe Shiminsky, Bonnie Shum, Sebastian Teitz, Bernice Westrek and Stacy L. Springs
      PDA Journal of Pharmaceutical Science and Technology March 2023, 77 (2) 115-132; DOI: https://doi.org/10.5731/pdajpst.2021.012691

C

  1. Camire, Joseph

    1. Evaluation of the Design, Development, and Performance of a Mass-Flow Based, Open-Source Buffer Manufacturing System
      Natraj Ram, Jeff Johnson, Hiren Ardeshna, Joseph Camire, Ryan Campbell, Doan Chau, Sam Gardner, Kevin Gibson, Joey Norikane, Paul Randolph, Kelly Smith, Katherine Stafford, Rachel Swamy, Shana Usery and Kelvin H. Lee
      PDA Journal of Pharmaceutical Science and Technology March 2023, 77 (2) 79-98; DOI: https://doi.org/10.5731/pdajpst.2021.012660

  2. Campbell, Ryan

    1. Evaluation of the Design, Development, and Performance of a Mass-Flow Based, Open-Source Buffer Manufacturing System
      Natraj Ram, Jeff Johnson, Hiren Ardeshna, Joseph Camire, Ryan Campbell, Doan Chau, Sam Gardner, Kevin Gibson, Joey Norikane, Paul Randolph, Kelly Smith, Katherine Stafford, Rachel Swamy, Shana Usery and Kelvin H. Lee
      PDA Journal of Pharmaceutical Science and Technology March 2023, 77 (2) 79-98; DOI: https://doi.org/10.5731/pdajpst.2021.012660

  3. Chan, Shawn

    1. MIT CAACB Risk Assessment Case Study: Assessing Virus Cross-Contamination Risk between Two Simultaneous Processes in an Open Biomanufacturing Facility
      Andrea L. Koenigsberg, Veronica Fowler, Reuben Domike, Audrey Brussel, Paul W. Barone, Flora J. Keumurian, James Leung, Michael E. Wiebe, Michael T. Brewer, Shawn Chan, Nicolas Dumey, Anne Fournillier, Marcella Goodnight, Johanna Kindermann, Richard Leavy, Buyoung Lee, Stefan Minning, Marie Murphy, Eric Myers, Armen Nahabedian, Kavita Nanda, Sandi Parriott, GK Raju, Ciaran Scallan, Stephanie Schoch, Joe Shiminsky, Bonnie Shum, Sebastian Teitz, Bernice Westrek and Stacy L. Springs
      PDA Journal of Pharmaceutical Science and Technology March 2023, 77 (2) 115-132; DOI: https://doi.org/10.5731/pdajpst.2021.012691

  4. Chau, Doan

    1. Evaluation of the Design, Development, and Performance of a Mass-Flow Based, Open-Source Buffer Manufacturing System
      Natraj Ram, Jeff Johnson, Hiren Ardeshna, Joseph Camire, Ryan Campbell, Doan Chau, Sam Gardner, Kevin Gibson, Joey Norikane, Paul Randolph, Kelly Smith, Katherine Stafford, Rachel Swamy, Shana Usery and Kelvin H. Lee
      PDA Journal of Pharmaceutical Science and Technology March 2023, 77 (2) 79-98; DOI: https://doi.org/10.5731/pdajpst.2021.012660

  5. Cournoyer, Antoine

    1. An Investigation into the Spatial Distribution of Moisture in Freeze-Dried Products Using NIR Spectroscopy and Chemical Imaging
      Azheruddin Mohammed, Antoine Cournoyer and Ryan Gosselin
      PDA Journal of Pharmaceutical Science and Technology March 2023, 77 (2) 55-66; DOI: https://doi.org/10.5731/pdajpst.2020.012443

D

  1. Domike, Reuben

    1. MIT CAACB Risk Assessment Case Study: Assessing Virus Cross-Contamination Risk between Two Simultaneous Processes in an Open Biomanufacturing Facility
      Andrea L. Koenigsberg, Veronica Fowler, Reuben Domike, Audrey Brussel, Paul W. Barone, Flora J. Keumurian, James Leung, Michael E. Wiebe, Michael T. Brewer, Shawn Chan, Nicolas Dumey, Anne Fournillier, Marcella Goodnight, Johanna Kindermann, Richard Leavy, Buyoung Lee, Stefan Minning, Marie Murphy, Eric Myers, Armen Nahabedian, Kavita Nanda, Sandi Parriott, GK Raju, Ciaran Scallan, Stephanie Schoch, Joe Shiminsky, Bonnie Shum, Sebastian Teitz, Bernice Westrek and Stacy L. Springs
      PDA Journal of Pharmaceutical Science and Technology March 2023, 77 (2) 115-132; DOI: https://doi.org/10.5731/pdajpst.2021.012691

  2. Dumey, Nicolas

    1. MIT CAACB Risk Assessment Case Study: Assessing Virus Cross-Contamination Risk between Two Simultaneous Processes in an Open Biomanufacturing Facility
      Andrea L. Koenigsberg, Veronica Fowler, Reuben Domike, Audrey Brussel, Paul W. Barone, Flora J. Keumurian, James Leung, Michael E. Wiebe, Michael T. Brewer, Shawn Chan, Nicolas Dumey, Anne Fournillier, Marcella Goodnight, Johanna Kindermann, Richard Leavy, Buyoung Lee, Stefan Minning, Marie Murphy, Eric Myers, Armen Nahabedian, Kavita Nanda, Sandi Parriott, GK Raju, Ciaran Scallan, Stephanie Schoch, Joe Shiminsky, Bonnie Shum, Sebastian Teitz, Bernice Westrek and Stacy L. Springs
      PDA Journal of Pharmaceutical Science and Technology March 2023, 77 (2) 115-132; DOI: https://doi.org/10.5731/pdajpst.2021.012691

F

  1. Fournillier, Anne

    1. MIT CAACB Risk Assessment Case Study: Assessing Virus Cross-Contamination Risk between Two Simultaneous Processes in an Open Biomanufacturing Facility
      Andrea L. Koenigsberg, Veronica Fowler, Reuben Domike, Audrey Brussel, Paul W. Barone, Flora J. Keumurian, James Leung, Michael E. Wiebe, Michael T. Brewer, Shawn Chan, Nicolas Dumey, Anne Fournillier, Marcella Goodnight, Johanna Kindermann, Richard Leavy, Buyoung Lee, Stefan Minning, Marie Murphy, Eric Myers, Armen Nahabedian, Kavita Nanda, Sandi Parriott, GK Raju, Ciaran Scallan, Stephanie Schoch, Joe Shiminsky, Bonnie Shum, Sebastian Teitz, Bernice Westrek and Stacy L. Springs
      PDA Journal of Pharmaceutical Science and Technology March 2023, 77 (2) 115-132; DOI: https://doi.org/10.5731/pdajpst.2021.012691

  2. Fowler, Veronica

    1. MIT CAACB Risk Assessment Case Study: Assessing Virus Cross-Contamination Risk between Two Simultaneous Processes in an Open Biomanufacturing Facility
      Andrea L. Koenigsberg, Veronica Fowler, Reuben Domike, Audrey Brussel, Paul W. Barone, Flora J. Keumurian, James Leung, Michael E. Wiebe, Michael T. Brewer, Shawn Chan, Nicolas Dumey, Anne Fournillier, Marcella Goodnight, Johanna Kindermann, Richard Leavy, Buyoung Lee, Stefan Minning, Marie Murphy, Eric Myers, Armen Nahabedian, Kavita Nanda, Sandi Parriott, GK Raju, Ciaran Scallan, Stephanie Schoch, Joe Shiminsky, Bonnie Shum, Sebastian Teitz, Bernice Westrek and Stacy L. Springs
      PDA Journal of Pharmaceutical Science and Technology March 2023, 77 (2) 115-132; DOI: https://doi.org/10.5731/pdajpst.2021.012691

G

  1. Gardner, Sam

    1. Evaluation of the Design, Development, and Performance of a Mass-Flow Based, Open-Source Buffer Manufacturing System
      Natraj Ram, Jeff Johnson, Hiren Ardeshna, Joseph Camire, Ryan Campbell, Doan Chau, Sam Gardner, Kevin Gibson, Joey Norikane, Paul Randolph, Kelly Smith, Katherine Stafford, Rachel Swamy, Shana Usery and Kelvin H. Lee
      PDA Journal of Pharmaceutical Science and Technology March 2023, 77 (2) 79-98; DOI: https://doi.org/10.5731/pdajpst.2021.012660

  2. Gibson, Kevin

    1. Evaluation of the Design, Development, and Performance of a Mass-Flow Based, Open-Source Buffer Manufacturing System
      Natraj Ram, Jeff Johnson, Hiren Ardeshna, Joseph Camire, Ryan Campbell, Doan Chau, Sam Gardner, Kevin Gibson, Joey Norikane, Paul Randolph, Kelly Smith, Katherine Stafford, Rachel Swamy, Shana Usery and Kelvin H. Lee
      PDA Journal of Pharmaceutical Science and Technology March 2023, 77 (2) 79-98; DOI: https://doi.org/10.5731/pdajpst.2021.012660

  3. Goodnight, Marcella

    1. MIT CAACB Risk Assessment Case Study: Assessing Virus Cross-Contamination Risk between Two Simultaneous Processes in an Open Biomanufacturing Facility
      Andrea L. Koenigsberg, Veronica Fowler, Reuben Domike, Audrey Brussel, Paul W. Barone, Flora J. Keumurian, James Leung, Michael E. Wiebe, Michael T. Brewer, Shawn Chan, Nicolas Dumey, Anne Fournillier, Marcella Goodnight, Johanna Kindermann, Richard Leavy, Buyoung Lee, Stefan Minning, Marie Murphy, Eric Myers, Armen Nahabedian, Kavita Nanda, Sandi Parriott, GK Raju, Ciaran Scallan, Stephanie Schoch, Joe Shiminsky, Bonnie Shum, Sebastian Teitz, Bernice Westrek and Stacy L. Springs
      PDA Journal of Pharmaceutical Science and Technology March 2023, 77 (2) 115-132; DOI: https://doi.org/10.5731/pdajpst.2021.012691

  4. Gosselin, Ryan

    1. An Investigation into the Spatial Distribution of Moisture in Freeze-Dried Products Using NIR Spectroscopy and Chemical Imaging
      Azheruddin Mohammed, Antoine Cournoyer and Ryan Gosselin
      PDA Journal of Pharmaceutical Science and Technology March 2023, 77 (2) 55-66; DOI: https://doi.org/10.5731/pdajpst.2020.012443

  5. GRACE, Dana

    1. Development and Qualification of Visible Particle Load Analysis Methods for Injectable Drug Product Primary Packaging Components
      Robin Wagner, Peter Masatani, Dana GRACE, Gianpiero TORRACA, Stephanie Moore and David Semin
      PDA Journal of Pharmaceutical Science and Technology March 2023, 77 (2) 99-114; DOI: https://doi.org/10.5731/pdajpst.2021.012710

H

  1. Heussner, Alexandra H.

    1. Investigating Tm Method Specificity Using Oligonucleotide Sequence Variants
      Alexandra H. Heussner, Sarina Schuler, Gerd Berger and Melanie Zerulla-Wernitz
      PDA Journal of Pharmaceutical Science and Technology March 2023, 77 (2) 67-78; DOI: https://doi.org/10.5731/pdajpst.2021.012694

  2. Hogreve, Marc

    1. Single-Use System Integrity IV: A Holistic Approach Based on Compiled Scientific Study Data
      Marc Hogreve
      PDA Journal of Pharmaceutical Science and Technology March 2023, 77 (2) 133-144; DOI: https://doi.org/10.5731/pdajpst.2022.012794

J

  1. Johnson, Jeff

    1. Evaluation of the Design, Development, and Performance of a Mass-Flow Based, Open-Source Buffer Manufacturing System
      Natraj Ram, Jeff Johnson, Hiren Ardeshna, Joseph Camire, Ryan Campbell, Doan Chau, Sam Gardner, Kevin Gibson, Joey Norikane, Paul Randolph, Kelly Smith, Katherine Stafford, Rachel Swamy, Shana Usery and Kelvin H. Lee
      PDA Journal of Pharmaceutical Science and Technology March 2023, 77 (2) 79-98; DOI: https://doi.org/10.5731/pdajpst.2021.012660

K

  1. Keumurian, Flora J.

    1. MIT CAACB Risk Assessment Case Study: Assessing Virus Cross-Contamination Risk between Two Simultaneous Processes in an Open Biomanufacturing Facility
      Andrea L. Koenigsberg, Veronica Fowler, Reuben Domike, Audrey Brussel, Paul W. Barone, Flora J. Keumurian, James Leung, Michael E. Wiebe, Michael T. Brewer, Shawn Chan, Nicolas Dumey, Anne Fournillier, Marcella Goodnight, Johanna Kindermann, Richard Leavy, Buyoung Lee, Stefan Minning, Marie Murphy, Eric Myers, Armen Nahabedian, Kavita Nanda, Sandi Parriott, GK Raju, Ciaran Scallan, Stephanie Schoch, Joe Shiminsky, Bonnie Shum, Sebastian Teitz, Bernice Westrek and Stacy L. Springs
      PDA Journal of Pharmaceutical Science and Technology March 2023, 77 (2) 115-132; DOI: https://doi.org/10.5731/pdajpst.2021.012691

  2. Kindermann, Johanna

    1. MIT CAACB Risk Assessment Case Study: Assessing Virus Cross-Contamination Risk between Two Simultaneous Processes in an Open Biomanufacturing Facility
      Andrea L. Koenigsberg, Veronica Fowler, Reuben Domike, Audrey Brussel, Paul W. Barone, Flora J. Keumurian, James Leung, Michael E. Wiebe, Michael T. Brewer, Shawn Chan, Nicolas Dumey, Anne Fournillier, Marcella Goodnight, Johanna Kindermann, Richard Leavy, Buyoung Lee, Stefan Minning, Marie Murphy, Eric Myers, Armen Nahabedian, Kavita Nanda, Sandi Parriott, GK Raju, Ciaran Scallan, Stephanie Schoch, Joe Shiminsky, Bonnie Shum, Sebastian Teitz, Bernice Westrek and Stacy L. Springs
      PDA Journal of Pharmaceutical Science and Technology March 2023, 77 (2) 115-132; DOI: https://doi.org/10.5731/pdajpst.2021.012691

  3. Koenigsberg, Andrea L.

    1. MIT CAACB Risk Assessment Case Study: Assessing Virus Cross-Contamination Risk between Two Simultaneous Processes in an Open Biomanufacturing Facility
      Andrea L. Koenigsberg, Veronica Fowler, Reuben Domike, Audrey Brussel, Paul W. Barone, Flora J. Keumurian, James Leung, Michael E. Wiebe, Michael T. Brewer, Shawn Chan, Nicolas Dumey, Anne Fournillier, Marcella Goodnight, Johanna Kindermann, Richard Leavy, Buyoung Lee, Stefan Minning, Marie Murphy, Eric Myers, Armen Nahabedian, Kavita Nanda, Sandi Parriott, GK Raju, Ciaran Scallan, Stephanie Schoch, Joe Shiminsky, Bonnie Shum, Sebastian Teitz, Bernice Westrek and Stacy L. Springs
      PDA Journal of Pharmaceutical Science and Technology March 2023, 77 (2) 115-132; DOI: https://doi.org/10.5731/pdajpst.2021.012691

L

  1. Leavy, Richard

    1. MIT CAACB Risk Assessment Case Study: Assessing Virus Cross-Contamination Risk between Two Simultaneous Processes in an Open Biomanufacturing Facility
      Andrea L. Koenigsberg, Veronica Fowler, Reuben Domike, Audrey Brussel, Paul W. Barone, Flora J. Keumurian, James Leung, Michael E. Wiebe, Michael T. Brewer, Shawn Chan, Nicolas Dumey, Anne Fournillier, Marcella Goodnight, Johanna Kindermann, Richard Leavy, Buyoung Lee, Stefan Minning, Marie Murphy, Eric Myers, Armen Nahabedian, Kavita Nanda, Sandi Parriott, GK Raju, Ciaran Scallan, Stephanie Schoch, Joe Shiminsky, Bonnie Shum, Sebastian Teitz, Bernice Westrek and Stacy L. Springs
      PDA Journal of Pharmaceutical Science and Technology March 2023, 77 (2) 115-132; DOI: https://doi.org/10.5731/pdajpst.2021.012691

  2. Lee, Buyoung

    1. MIT CAACB Risk Assessment Case Study: Assessing Virus Cross-Contamination Risk between Two Simultaneous Processes in an Open Biomanufacturing Facility
      Andrea L. Koenigsberg, Veronica Fowler, Reuben Domike, Audrey Brussel, Paul W. Barone, Flora J. Keumurian, James Leung, Michael E. Wiebe, Michael T. Brewer, Shawn Chan, Nicolas Dumey, Anne Fournillier, Marcella Goodnight, Johanna Kindermann, Richard Leavy, Buyoung Lee, Stefan Minning, Marie Murphy, Eric Myers, Armen Nahabedian, Kavita Nanda, Sandi Parriott, GK Raju, Ciaran Scallan, Stephanie Schoch, Joe Shiminsky, Bonnie Shum, Sebastian Teitz, Bernice Westrek and Stacy L. Springs
      PDA Journal of Pharmaceutical Science and Technology March 2023, 77 (2) 115-132; DOI: https://doi.org/10.5731/pdajpst.2021.012691

  3. Lee, Kelvin H.

    1. Evaluation of the Design, Development, and Performance of a Mass-Flow Based, Open-Source Buffer Manufacturing System
      Natraj Ram, Jeff Johnson, Hiren Ardeshna, Joseph Camire, Ryan Campbell, Doan Chau, Sam Gardner, Kevin Gibson, Joey Norikane, Paul Randolph, Kelly Smith, Katherine Stafford, Rachel Swamy, Shana Usery and Kelvin H. Lee
      PDA Journal of Pharmaceutical Science and Technology March 2023, 77 (2) 79-98; DOI: https://doi.org/10.5731/pdajpst.2021.012660

  4. Leung, James

    1. MIT CAACB Risk Assessment Case Study: Assessing Virus Cross-Contamination Risk between Two Simultaneous Processes in an Open Biomanufacturing Facility
      Andrea L. Koenigsberg, Veronica Fowler, Reuben Domike, Audrey Brussel, Paul W. Barone, Flora J. Keumurian, James Leung, Michael E. Wiebe, Michael T. Brewer, Shawn Chan, Nicolas Dumey, Anne Fournillier, Marcella Goodnight, Johanna Kindermann, Richard Leavy, Buyoung Lee, Stefan Minning, Marie Murphy, Eric Myers, Armen Nahabedian, Kavita Nanda, Sandi Parriott, GK Raju, Ciaran Scallan, Stephanie Schoch, Joe Shiminsky, Bonnie Shum, Sebastian Teitz, Bernice Westrek and Stacy L. Springs
      PDA Journal of Pharmaceutical Science and Technology March 2023, 77 (2) 115-132; DOI: https://doi.org/10.5731/pdajpst.2021.012691

M

  1. Masatani, Peter

    1. Development and Qualification of Visible Particle Load Analysis Methods for Injectable Drug Product Primary Packaging Components
      Robin Wagner, Peter Masatani, Dana GRACE, Gianpiero TORRACA, Stephanie Moore and David Semin
      PDA Journal of Pharmaceutical Science and Technology March 2023, 77 (2) 99-114; DOI: https://doi.org/10.5731/pdajpst.2021.012710

  2. Minning, Stefan

    1. MIT CAACB Risk Assessment Case Study: Assessing Virus Cross-Contamination Risk between Two Simultaneous Processes in an Open Biomanufacturing Facility
      Andrea L. Koenigsberg, Veronica Fowler, Reuben Domike, Audrey Brussel, Paul W. Barone, Flora J. Keumurian, James Leung, Michael E. Wiebe, Michael T. Brewer, Shawn Chan, Nicolas Dumey, Anne Fournillier, Marcella Goodnight, Johanna Kindermann, Richard Leavy, Buyoung Lee, Stefan Minning, Marie Murphy, Eric Myers, Armen Nahabedian, Kavita Nanda, Sandi Parriott, GK Raju, Ciaran Scallan, Stephanie Schoch, Joe Shiminsky, Bonnie Shum, Sebastian Teitz, Bernice Westrek and Stacy L. Springs
      PDA Journal of Pharmaceutical Science and Technology March 2023, 77 (2) 115-132; DOI: https://doi.org/10.5731/pdajpst.2021.012691

  3. Mohammed, Azheruddin

    1. An Investigation into the Spatial Distribution of Moisture in Freeze-Dried Products Using NIR Spectroscopy and Chemical Imaging
      Azheruddin Mohammed, Antoine Cournoyer and Ryan Gosselin
      PDA Journal of Pharmaceutical Science and Technology March 2023, 77 (2) 55-66; DOI: https://doi.org/10.5731/pdajpst.2020.012443

  4. Moore, Stephanie

    1. Development and Qualification of Visible Particle Load Analysis Methods for Injectable Drug Product Primary Packaging Components
      Robin Wagner, Peter Masatani, Dana GRACE, Gianpiero TORRACA, Stephanie Moore and David Semin
      PDA Journal of Pharmaceutical Science and Technology March 2023, 77 (2) 99-114; DOI: https://doi.org/10.5731/pdajpst.2021.012710

  5. Murphy, Marie

    1. MIT CAACB Risk Assessment Case Study: Assessing Virus Cross-Contamination Risk between Two Simultaneous Processes in an Open Biomanufacturing Facility
      Andrea L. Koenigsberg, Veronica Fowler, Reuben Domike, Audrey Brussel, Paul W. Barone, Flora J. Keumurian, James Leung, Michael E. Wiebe, Michael T. Brewer, Shawn Chan, Nicolas Dumey, Anne Fournillier, Marcella Goodnight, Johanna Kindermann, Richard Leavy, Buyoung Lee, Stefan Minning, Marie Murphy, Eric Myers, Armen Nahabedian, Kavita Nanda, Sandi Parriott, GK Raju, Ciaran Scallan, Stephanie Schoch, Joe Shiminsky, Bonnie Shum, Sebastian Teitz, Bernice Westrek and Stacy L. Springs
      PDA Journal of Pharmaceutical Science and Technology March 2023, 77 (2) 115-132; DOI: https://doi.org/10.5731/pdajpst.2021.012691

  6. Myers, Eric

    1. MIT CAACB Risk Assessment Case Study: Assessing Virus Cross-Contamination Risk between Two Simultaneous Processes in an Open Biomanufacturing Facility
      Andrea L. Koenigsberg, Veronica Fowler, Reuben Domike, Audrey Brussel, Paul W. Barone, Flora J. Keumurian, James Leung, Michael E. Wiebe, Michael T. Brewer, Shawn Chan, Nicolas Dumey, Anne Fournillier, Marcella Goodnight, Johanna Kindermann, Richard Leavy, Buyoung Lee, Stefan Minning, Marie Murphy, Eric Myers, Armen Nahabedian, Kavita Nanda, Sandi Parriott, GK Raju, Ciaran Scallan, Stephanie Schoch, Joe Shiminsky, Bonnie Shum, Sebastian Teitz, Bernice Westrek and Stacy L. Springs
      PDA Journal of Pharmaceutical Science and Technology March 2023, 77 (2) 115-132; DOI: https://doi.org/10.5731/pdajpst.2021.012691

N

  1. Nahabedian, Armen

    1. MIT CAACB Risk Assessment Case Study: Assessing Virus Cross-Contamination Risk between Two Simultaneous Processes in an Open Biomanufacturing Facility
      Andrea L. Koenigsberg, Veronica Fowler, Reuben Domike, Audrey Brussel, Paul W. Barone, Flora J. Keumurian, James Leung, Michael E. Wiebe, Michael T. Brewer, Shawn Chan, Nicolas Dumey, Anne Fournillier, Marcella Goodnight, Johanna Kindermann, Richard Leavy, Buyoung Lee, Stefan Minning, Marie Murphy, Eric Myers, Armen Nahabedian, Kavita Nanda, Sandi Parriott, GK Raju, Ciaran Scallan, Stephanie Schoch, Joe Shiminsky, Bonnie Shum, Sebastian Teitz, Bernice Westrek and Stacy L. Springs
      PDA Journal of Pharmaceutical Science and Technology March 2023, 77 (2) 115-132; DOI: https://doi.org/10.5731/pdajpst.2021.012691

  2. Nanda, Kavita

    1. MIT CAACB Risk Assessment Case Study: Assessing Virus Cross-Contamination Risk between Two Simultaneous Processes in an Open Biomanufacturing Facility
      Andrea L. Koenigsberg, Veronica Fowler, Reuben Domike, Audrey Brussel, Paul W. Barone, Flora J. Keumurian, James Leung, Michael E. Wiebe, Michael T. Brewer, Shawn Chan, Nicolas Dumey, Anne Fournillier, Marcella Goodnight, Johanna Kindermann, Richard Leavy, Buyoung Lee, Stefan Minning, Marie Murphy, Eric Myers, Armen Nahabedian, Kavita Nanda, Sandi Parriott, GK Raju, Ciaran Scallan, Stephanie Schoch, Joe Shiminsky, Bonnie Shum, Sebastian Teitz, Bernice Westrek and Stacy L. Springs
      PDA Journal of Pharmaceutical Science and Technology March 2023, 77 (2) 115-132; DOI: https://doi.org/10.5731/pdajpst.2021.012691

  3. Norikane, Joey

    1. Evaluation of the Design, Development, and Performance of a Mass-Flow Based, Open-Source Buffer Manufacturing System
      Natraj Ram, Jeff Johnson, Hiren Ardeshna, Joseph Camire, Ryan Campbell, Doan Chau, Sam Gardner, Kevin Gibson, Joey Norikane, Paul Randolph, Kelly Smith, Katherine Stafford, Rachel Swamy, Shana Usery and Kelvin H. Lee
      PDA Journal of Pharmaceutical Science and Technology March 2023, 77 (2) 79-98; DOI: https://doi.org/10.5731/pdajpst.2021.012660

P

  1. Parriott, Sandi

    1. MIT CAACB Risk Assessment Case Study: Assessing Virus Cross-Contamination Risk between Two Simultaneous Processes in an Open Biomanufacturing Facility
      Andrea L. Koenigsberg, Veronica Fowler, Reuben Domike, Audrey Brussel, Paul W. Barone, Flora J. Keumurian, James Leung, Michael E. Wiebe, Michael T. Brewer, Shawn Chan, Nicolas Dumey, Anne Fournillier, Marcella Goodnight, Johanna Kindermann, Richard Leavy, Buyoung Lee, Stefan Minning, Marie Murphy, Eric Myers, Armen Nahabedian, Kavita Nanda, Sandi Parriott, GK Raju, Ciaran Scallan, Stephanie Schoch, Joe Shiminsky, Bonnie Shum, Sebastian Teitz, Bernice Westrek and Stacy L. Springs
      PDA Journal of Pharmaceutical Science and Technology March 2023, 77 (2) 115-132; DOI: https://doi.org/10.5731/pdajpst.2021.012691

R

  1. Raju, GK

    1. MIT CAACB Risk Assessment Case Study: Assessing Virus Cross-Contamination Risk between Two Simultaneous Processes in an Open Biomanufacturing Facility
      Andrea L. Koenigsberg, Veronica Fowler, Reuben Domike, Audrey Brussel, Paul W. Barone, Flora J. Keumurian, James Leung, Michael E. Wiebe, Michael T. Brewer, Shawn Chan, Nicolas Dumey, Anne Fournillier, Marcella Goodnight, Johanna Kindermann, Richard Leavy, Buyoung Lee, Stefan Minning, Marie Murphy, Eric Myers, Armen Nahabedian, Kavita Nanda, Sandi Parriott, GK Raju, Ciaran Scallan, Stephanie Schoch, Joe Shiminsky, Bonnie Shum, Sebastian Teitz, Bernice Westrek and Stacy L. Springs
      PDA Journal of Pharmaceutical Science and Technology March 2023, 77 (2) 115-132; DOI: https://doi.org/10.5731/pdajpst.2021.012691

  2. Ram, Natraj

    1. Evaluation of the Design, Development, and Performance of a Mass-Flow Based, Open-Source Buffer Manufacturing System
      Natraj Ram, Jeff Johnson, Hiren Ardeshna, Joseph Camire, Ryan Campbell, Doan Chau, Sam Gardner, Kevin Gibson, Joey Norikane, Paul Randolph, Kelly Smith, Katherine Stafford, Rachel Swamy, Shana Usery and Kelvin H. Lee
      PDA Journal of Pharmaceutical Science and Technology March 2023, 77 (2) 79-98; DOI: https://doi.org/10.5731/pdajpst.2021.012660

  3. Randolph, Paul

    1. Evaluation of the Design, Development, and Performance of a Mass-Flow Based, Open-Source Buffer Manufacturing System
      Natraj Ram, Jeff Johnson, Hiren Ardeshna, Joseph Camire, Ryan Campbell, Doan Chau, Sam Gardner, Kevin Gibson, Joey Norikane, Paul Randolph, Kelly Smith, Katherine Stafford, Rachel Swamy, Shana Usery and Kelvin H. Lee
      PDA Journal of Pharmaceutical Science and Technology March 2023, 77 (2) 79-98; DOI: https://doi.org/10.5731/pdajpst.2021.012660

S

  1. Scallan, Ciaran

    1. MIT CAACB Risk Assessment Case Study: Assessing Virus Cross-Contamination Risk between Two Simultaneous Processes in an Open Biomanufacturing Facility
      Andrea L. Koenigsberg, Veronica Fowler, Reuben Domike, Audrey Brussel, Paul W. Barone, Flora J. Keumurian, James Leung, Michael E. Wiebe, Michael T. Brewer, Shawn Chan, Nicolas Dumey, Anne Fournillier, Marcella Goodnight, Johanna Kindermann, Richard Leavy, Buyoung Lee, Stefan Minning, Marie Murphy, Eric Myers, Armen Nahabedian, Kavita Nanda, Sandi Parriott, GK Raju, Ciaran Scallan, Stephanie Schoch, Joe Shiminsky, Bonnie Shum, Sebastian Teitz, Bernice Westrek and Stacy L. Springs
      PDA Journal of Pharmaceutical Science and Technology March 2023, 77 (2) 115-132; DOI: https://doi.org/10.5731/pdajpst.2021.012691

  2. Schoch, Stephanie

    1. MIT CAACB Risk Assessment Case Study: Assessing Virus Cross-Contamination Risk between Two Simultaneous Processes in an Open Biomanufacturing Facility
      Andrea L. Koenigsberg, Veronica Fowler, Reuben Domike, Audrey Brussel, Paul W. Barone, Flora J. Keumurian, James Leung, Michael E. Wiebe, Michael T. Brewer, Shawn Chan, Nicolas Dumey, Anne Fournillier, Marcella Goodnight, Johanna Kindermann, Richard Leavy, Buyoung Lee, Stefan Minning, Marie Murphy, Eric Myers, Armen Nahabedian, Kavita Nanda, Sandi Parriott, GK Raju, Ciaran Scallan, Stephanie Schoch, Joe Shiminsky, Bonnie Shum, Sebastian Teitz, Bernice Westrek and Stacy L. Springs
      PDA Journal of Pharmaceutical Science and Technology March 2023, 77 (2) 115-132; DOI: https://doi.org/10.5731/pdajpst.2021.012691

  3. Schuler, Sarina

    1. Investigating Tm Method Specificity Using Oligonucleotide Sequence Variants
      Alexandra H. Heussner, Sarina Schuler, Gerd Berger and Melanie Zerulla-Wernitz
      PDA Journal of Pharmaceutical Science and Technology March 2023, 77 (2) 67-78; DOI: https://doi.org/10.5731/pdajpst.2021.012694

  4. Semin, David

    1. Development and Qualification of Visible Particle Load Analysis Methods for Injectable Drug Product Primary Packaging Components
      Robin Wagner, Peter Masatani, Dana GRACE, Gianpiero TORRACA, Stephanie Moore and David Semin
      PDA Journal of Pharmaceutical Science and Technology March 2023, 77 (2) 99-114; DOI: https://doi.org/10.5731/pdajpst.2021.012710

  5. Shiminsky, Joe

    1. MIT CAACB Risk Assessment Case Study: Assessing Virus Cross-Contamination Risk between Two Simultaneous Processes in an Open Biomanufacturing Facility
      Andrea L. Koenigsberg, Veronica Fowler, Reuben Domike, Audrey Brussel, Paul W. Barone, Flora J. Keumurian, James Leung, Michael E. Wiebe, Michael T. Brewer, Shawn Chan, Nicolas Dumey, Anne Fournillier, Marcella Goodnight, Johanna Kindermann, Richard Leavy, Buyoung Lee, Stefan Minning, Marie Murphy, Eric Myers, Armen Nahabedian, Kavita Nanda, Sandi Parriott, GK Raju, Ciaran Scallan, Stephanie Schoch, Joe Shiminsky, Bonnie Shum, Sebastian Teitz, Bernice Westrek and Stacy L. Springs
      PDA Journal of Pharmaceutical Science and Technology March 2023, 77 (2) 115-132; DOI: https://doi.org/10.5731/pdajpst.2021.012691

  6. Shum, Bonnie

    1. MIT CAACB Risk Assessment Case Study: Assessing Virus Cross-Contamination Risk between Two Simultaneous Processes in an Open Biomanufacturing Facility
      Andrea L. Koenigsberg, Veronica Fowler, Reuben Domike, Audrey Brussel, Paul W. Barone, Flora J. Keumurian, James Leung, Michael E. Wiebe, Michael T. Brewer, Shawn Chan, Nicolas Dumey, Anne Fournillier, Marcella Goodnight, Johanna Kindermann, Richard Leavy, Buyoung Lee, Stefan Minning, Marie Murphy, Eric Myers, Armen Nahabedian, Kavita Nanda, Sandi Parriott, GK Raju, Ciaran Scallan, Stephanie Schoch, Joe Shiminsky, Bonnie Shum, Sebastian Teitz, Bernice Westrek and Stacy L. Springs
      PDA Journal of Pharmaceutical Science and Technology March 2023, 77 (2) 115-132; DOI: https://doi.org/10.5731/pdajpst.2021.012691

  7. Smith, Kelly

    1. Evaluation of the Design, Development, and Performance of a Mass-Flow Based, Open-Source Buffer Manufacturing System
      Natraj Ram, Jeff Johnson, Hiren Ardeshna, Joseph Camire, Ryan Campbell, Doan Chau, Sam Gardner, Kevin Gibson, Joey Norikane, Paul Randolph, Kelly Smith, Katherine Stafford, Rachel Swamy, Shana Usery and Kelvin H. Lee
      PDA Journal of Pharmaceutical Science and Technology March 2023, 77 (2) 79-98; DOI: https://doi.org/10.5731/pdajpst.2021.012660

  8. Springs, Stacy L.

    1. MIT CAACB Risk Assessment Case Study: Assessing Virus Cross-Contamination Risk between Two Simultaneous Processes in an Open Biomanufacturing Facility
      Andrea L. Koenigsberg, Veronica Fowler, Reuben Domike, Audrey Brussel, Paul W. Barone, Flora J. Keumurian, James Leung, Michael E. Wiebe, Michael T. Brewer, Shawn Chan, Nicolas Dumey, Anne Fournillier, Marcella Goodnight, Johanna Kindermann, Richard Leavy, Buyoung Lee, Stefan Minning, Marie Murphy, Eric Myers, Armen Nahabedian, Kavita Nanda, Sandi Parriott, GK Raju, Ciaran Scallan, Stephanie Schoch, Joe Shiminsky, Bonnie Shum, Sebastian Teitz, Bernice Westrek and Stacy L. Springs
      PDA Journal of Pharmaceutical Science and Technology March 2023, 77 (2) 115-132; DOI: https://doi.org/10.5731/pdajpst.2021.012691

  9. Stafford, Katherine

    1. Evaluation of the Design, Development, and Performance of a Mass-Flow Based, Open-Source Buffer Manufacturing System
      Natraj Ram, Jeff Johnson, Hiren Ardeshna, Joseph Camire, Ryan Campbell, Doan Chau, Sam Gardner, Kevin Gibson, Joey Norikane, Paul Randolph, Kelly Smith, Katherine Stafford, Rachel Swamy, Shana Usery and Kelvin H. Lee
      PDA Journal of Pharmaceutical Science and Technology March 2023, 77 (2) 79-98; DOI: https://doi.org/10.5731/pdajpst.2021.012660

  10. Swamy, Rachel

    1. Evaluation of the Design, Development, and Performance of a Mass-Flow Based, Open-Source Buffer Manufacturing System
      Natraj Ram, Jeff Johnson, Hiren Ardeshna, Joseph Camire, Ryan Campbell, Doan Chau, Sam Gardner, Kevin Gibson, Joey Norikane, Paul Randolph, Kelly Smith, Katherine Stafford, Rachel Swamy, Shana Usery and Kelvin H. Lee
      PDA Journal of Pharmaceutical Science and Technology March 2023, 77 (2) 79-98; DOI: https://doi.org/10.5731/pdajpst.2021.012660

T

  1. Teitz, Sebastian

    1. MIT CAACB Risk Assessment Case Study: Assessing Virus Cross-Contamination Risk between Two Simultaneous Processes in an Open Biomanufacturing Facility
      Andrea L. Koenigsberg, Veronica Fowler, Reuben Domike, Audrey Brussel, Paul W. Barone, Flora J. Keumurian, James Leung, Michael E. Wiebe, Michael T. Brewer, Shawn Chan, Nicolas Dumey, Anne Fournillier, Marcella Goodnight, Johanna Kindermann, Richard Leavy, Buyoung Lee, Stefan Minning, Marie Murphy, Eric Myers, Armen Nahabedian, Kavita Nanda, Sandi Parriott, GK Raju, Ciaran Scallan, Stephanie Schoch, Joe Shiminsky, Bonnie Shum, Sebastian Teitz, Bernice Westrek and Stacy L. Springs
      PDA Journal of Pharmaceutical Science and Technology March 2023, 77 (2) 115-132; DOI: https://doi.org/10.5731/pdajpst.2021.012691

  2. TORRACA, Gianpiero

    1. Development and Qualification of Visible Particle Load Analysis Methods for Injectable Drug Product Primary Packaging Components
      Robin Wagner, Peter Masatani, Dana GRACE, Gianpiero TORRACA, Stephanie Moore and David Semin
      PDA Journal of Pharmaceutical Science and Technology March 2023, 77 (2) 99-114; DOI: https://doi.org/10.5731/pdajpst.2021.012710

U

  1. Usery, Shana

    1. Evaluation of the Design, Development, and Performance of a Mass-Flow Based, Open-Source Buffer Manufacturing System
      Natraj Ram, Jeff Johnson, Hiren Ardeshna, Joseph Camire, Ryan Campbell, Doan Chau, Sam Gardner, Kevin Gibson, Joey Norikane, Paul Randolph, Kelly Smith, Katherine Stafford, Rachel Swamy, Shana Usery and Kelvin H. Lee
      PDA Journal of Pharmaceutical Science and Technology March 2023, 77 (2) 79-98; DOI: https://doi.org/10.5731/pdajpst.2021.012660

W

  1. Wagner, Robin

    1. Development and Qualification of Visible Particle Load Analysis Methods for Injectable Drug Product Primary Packaging Components
      Robin Wagner, Peter Masatani, Dana GRACE, Gianpiero TORRACA, Stephanie Moore and David Semin
      PDA Journal of Pharmaceutical Science and Technology March 2023, 77 (2) 99-114; DOI: https://doi.org/10.5731/pdajpst.2021.012710

  2. Westrek, Bernice

    1. MIT CAACB Risk Assessment Case Study: Assessing Virus Cross-Contamination Risk between Two Simultaneous Processes in an Open Biomanufacturing Facility
      Andrea L. Koenigsberg, Veronica Fowler, Reuben Domike, Audrey Brussel, Paul W. Barone, Flora J. Keumurian, James Leung, Michael E. Wiebe, Michael T. Brewer, Shawn Chan, Nicolas Dumey, Anne Fournillier, Marcella Goodnight, Johanna Kindermann, Richard Leavy, Buyoung Lee, Stefan Minning, Marie Murphy, Eric Myers, Armen Nahabedian, Kavita Nanda, Sandi Parriott, GK Raju, Ciaran Scallan, Stephanie Schoch, Joe Shiminsky, Bonnie Shum, Sebastian Teitz, Bernice Westrek and Stacy L. Springs
      PDA Journal of Pharmaceutical Science and Technology March 2023, 77 (2) 115-132; DOI: https://doi.org/10.5731/pdajpst.2021.012691

  3. Wiebe, Michael E.

    1. MIT CAACB Risk Assessment Case Study: Assessing Virus Cross-Contamination Risk between Two Simultaneous Processes in an Open Biomanufacturing Facility
      Andrea L. Koenigsberg, Veronica Fowler, Reuben Domike, Audrey Brussel, Paul W. Barone, Flora J. Keumurian, James Leung, Michael E. Wiebe, Michael T. Brewer, Shawn Chan, Nicolas Dumey, Anne Fournillier, Marcella Goodnight, Johanna Kindermann, Richard Leavy, Buyoung Lee, Stefan Minning, Marie Murphy, Eric Myers, Armen Nahabedian, Kavita Nanda, Sandi Parriott, GK Raju, Ciaran Scallan, Stephanie Schoch, Joe Shiminsky, Bonnie Shum, Sebastian Teitz, Bernice Westrek and Stacy L. Springs
      PDA Journal of Pharmaceutical Science and Technology March 2023, 77 (2) 115-132; DOI: https://doi.org/10.5731/pdajpst.2021.012691

  4. Wright, Glenn E.

    1. New PDA President Says Hello to PDA Journal
      Glenn E. Wright
      PDA Journal of Pharmaceutical Science and Technology March 2023, 77 (2) 54; DOI: https://doi.org/10.5731/pdajpst.2023.001323

Z

  1. Zerulla-Wernitz, Melanie

    1. Investigating Tm Method Specificity Using Oligonucleotide Sequence Variants
      Alexandra H. Heussner, Sarina Schuler, Gerd Berger and Melanie Zerulla-Wernitz
      PDA Journal of Pharmaceutical Science and Technology March 2023, 77 (2) 67-78; DOI: https://doi.org/10.5731/pdajpst.2021.012694
Back to top

In This Issue