Table of Contents

March/April 2020; Volume 74,Issue 2

A

  1. Almond, Louise

    1. Advancing Biologics Development Programs with Legacy Cell Lines: Advantages and Limitations of Genetic Testing for Addressing Clonality Concerns Prior to Availability of Late Stage Process and Product Consistency Data
      Paul Wu, Taymar Hartman, Louise Almond, Jennitte Stevens, John Thrift, Juhi Ojha, Christina Alves, David Shaw, Michael W. Laird, Robyn Emmins, Yuan Zhu, Ren Liu, Zhimei Du, Rolf Koehler, Thomas Jostock, Karin Anderson, Chris Campbell and Howard Clarke
      PDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 264-274; DOI: https://doi.org/10.5731/pdajpst.2018.009316

  2. Alves, Christina

    1. Advancing Biologics Development Programs with Legacy Cell Lines: Advantages and Limitations of Genetic Testing for Addressing Clonality Concerns Prior to Availability of Late Stage Process and Product Consistency Data
      Paul Wu, Taymar Hartman, Louise Almond, Jennitte Stevens, John Thrift, Juhi Ojha, Christina Alves, David Shaw, Michael W. Laird, Robyn Emmins, Yuan Zhu, Ren Liu, Zhimei Du, Rolf Koehler, Thomas Jostock, Karin Anderson, Chris Campbell and Howard Clarke
      PDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 264-274; DOI: https://doi.org/10.5731/pdajpst.2018.009316

  3. Anderson, Karin

    1. Advancing Biologics Development Programs with Legacy Cell Lines: Advantages and Limitations of Genetic Testing for Addressing Clonality Concerns Prior to Availability of Late Stage Process and Product Consistency Data
      Paul Wu, Taymar Hartman, Louise Almond, Jennitte Stevens, John Thrift, Juhi Ojha, Christina Alves, David Shaw, Michael W. Laird, Robyn Emmins, Yuan Zhu, Ren Liu, Zhimei Du, Rolf Koehler, Thomas Jostock, Karin Anderson, Chris Campbell and Howard Clarke
      PDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 264-274; DOI: https://doi.org/10.5731/pdajpst.2018.009316

  4. Arch-Douglas, Katherine

    1. Control Strategy Approach for a Well-Characterized Vaccine Drug Product
      Parag Kolhe, Khurram Sunasara, Lavinia Lewis, Michele Bailey Piatchek, Roberto Rodriguez and Katherine Arch-Douglas
      PDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 213-228; DOI: https://doi.org/10.5731/pdajpst.2018.009415

B

  1. Bailey Piatchek, Michele

    1. Control Strategy Approach for a Well-Characterized Vaccine Drug Product
      Parag Kolhe, Khurram Sunasara, Lavinia Lewis, Michele Bailey Piatchek, Roberto Rodriguez and Katherine Arch-Douglas
      PDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 213-228; DOI: https://doi.org/10.5731/pdajpst.2018.009415

  2. Breuning, Carl

    1. Bioprocess: Robustness with Respect to Mycoplasma Species
      Talia Faison, Julie Wang, Sarah Johnson, Matthew Brown, Meng-Jung Chiang, Sherri Dolan, Carl Breuning, Sai Rashmika Velugula-Yellela, Scott Lute, Erica J. Fratz-Berilla and Kurt Brorson
      PDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 201-212; DOI: https://doi.org/10.5731/pdajpst.2018.009613

  3. Brorson, Kurt

    1. Bioprocess: Robustness with Respect to Mycoplasma Species
      Talia Faison, Julie Wang, Sarah Johnson, Matthew Brown, Meng-Jung Chiang, Sherri Dolan, Carl Breuning, Sai Rashmika Velugula-Yellela, Scott Lute, Erica J. Fratz-Berilla and Kurt Brorson
      PDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 201-212; DOI: https://doi.org/10.5731/pdajpst.2018.009613

  4. Brown, Matthew

    1. Bioprocess: Robustness with Respect to Mycoplasma Species
      Talia Faison, Julie Wang, Sarah Johnson, Matthew Brown, Meng-Jung Chiang, Sherri Dolan, Carl Breuning, Sai Rashmika Velugula-Yellela, Scott Lute, Erica J. Fratz-Berilla and Kurt Brorson
      PDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 201-212; DOI: https://doi.org/10.5731/pdajpst.2018.009613

C

  1. Campbell, Chris

    1. Advancing Biologics Development Programs with Legacy Cell Lines: Advantages and Limitations of Genetic Testing for Addressing Clonality Concerns Prior to Availability of Late Stage Process and Product Consistency Data
      Paul Wu, Taymar Hartman, Louise Almond, Jennitte Stevens, John Thrift, Juhi Ojha, Christina Alves, David Shaw, Michael W. Laird, Robyn Emmins, Yuan Zhu, Ren Liu, Zhimei Du, Rolf Koehler, Thomas Jostock, Karin Anderson, Chris Campbell and Howard Clarke
      PDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 264-274; DOI: https://doi.org/10.5731/pdajpst.2018.009316

  2. Chiang, Meng-Jung

    1. Bioprocess: Robustness with Respect to Mycoplasma Species
      Talia Faison, Julie Wang, Sarah Johnson, Matthew Brown, Meng-Jung Chiang, Sherri Dolan, Carl Breuning, Sai Rashmika Velugula-Yellela, Scott Lute, Erica J. Fratz-Berilla and Kurt Brorson
      PDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 201-212; DOI: https://doi.org/10.5731/pdajpst.2018.009613

  3. Cirbo, Tim

    1. Disinfectant Efficacy: Understanding the Expectations and How to Design Effective Studies That Include Leveraging Multi-Site Data to Drive an Efficient Program
      Derek Willison-Parry, Stephen Yang, Ren-Yo Forng, Tim Cirbo, Aileen Mcmeel, Brian Kiler and Christopher Phillion
      PDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 249-263; DOI: https://doi.org/10.5731/pdajpst.2018.009662

  4. Clarke, Howard

    1. Advancing Biologics Development Programs with Legacy Cell Lines: Advantages and Limitations of Genetic Testing for Addressing Clonality Concerns Prior to Availability of Late Stage Process and Product Consistency Data
      Paul Wu, Taymar Hartman, Louise Almond, Jennitte Stevens, John Thrift, Juhi Ojha, Christina Alves, David Shaw, Michael W. Laird, Robyn Emmins, Yuan Zhu, Ren Liu, Zhimei Du, Rolf Koehler, Thomas Jostock, Karin Anderson, Chris Campbell and Howard Clarke
      PDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 264-274; DOI: https://doi.org/10.5731/pdajpst.2018.009316

  5. Cundell, Tony

    1. Risk Assessment Approach to Microbiological Controls of Cell Therapies
      Tony Cundell, Scott Drummond, Irving Ford, Dona Reber and Donald Singer; members of the Pharmaceutical Microbiology Expert Discussion Group
      PDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 229-248; DOI: https://doi.org/10.5731/pdajpst.2019.010546

D

  1. Dolan, Sherri

    1. Bioprocess: Robustness with Respect to Mycoplasma Species
      Talia Faison, Julie Wang, Sarah Johnson, Matthew Brown, Meng-Jung Chiang, Sherri Dolan, Carl Breuning, Sai Rashmika Velugula-Yellela, Scott Lute, Erica J. Fratz-Berilla and Kurt Brorson
      PDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 201-212; DOI: https://doi.org/10.5731/pdajpst.2018.009613

  2. Drummond, Scott

    1. Risk Assessment Approach to Microbiological Controls of Cell Therapies
      Tony Cundell, Scott Drummond, Irving Ford, Dona Reber and Donald Singer; members of the Pharmaceutical Microbiology Expert Discussion Group
      PDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 229-248; DOI: https://doi.org/10.5731/pdajpst.2019.010546

  3. Du, Zhimei

    1. Advancing Biologics Development Programs with Legacy Cell Lines: Advantages and Limitations of Genetic Testing for Addressing Clonality Concerns Prior to Availability of Late Stage Process and Product Consistency Data
      Paul Wu, Taymar Hartman, Louise Almond, Jennitte Stevens, John Thrift, Juhi Ojha, Christina Alves, David Shaw, Michael W. Laird, Robyn Emmins, Yuan Zhu, Ren Liu, Zhimei Du, Rolf Koehler, Thomas Jostock, Karin Anderson, Chris Campbell and Howard Clarke
      PDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 264-274; DOI: https://doi.org/10.5731/pdajpst.2018.009316

E

  1. Emmins, Robyn

    1. Advancing Biologics Development Programs with Legacy Cell Lines: Advantages and Limitations of Genetic Testing for Addressing Clonality Concerns Prior to Availability of Late Stage Process and Product Consistency Data
      Paul Wu, Taymar Hartman, Louise Almond, Jennitte Stevens, John Thrift, Juhi Ojha, Christina Alves, David Shaw, Michael W. Laird, Robyn Emmins, Yuan Zhu, Ren Liu, Zhimei Du, Rolf Koehler, Thomas Jostock, Karin Anderson, Chris Campbell and Howard Clarke
      PDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 264-274; DOI: https://doi.org/10.5731/pdajpst.2018.009316

F

  1. Faison, Talia

    1. Bioprocess: Robustness with Respect to Mycoplasma Species
      Talia Faison, Julie Wang, Sarah Johnson, Matthew Brown, Meng-Jung Chiang, Sherri Dolan, Carl Breuning, Sai Rashmika Velugula-Yellela, Scott Lute, Erica J. Fratz-Berilla and Kurt Brorson
      PDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 201-212; DOI: https://doi.org/10.5731/pdajpst.2018.009613

  2. Ford, Irving

    1. Risk Assessment Approach to Microbiological Controls of Cell Therapies
      Tony Cundell, Scott Drummond, Irving Ford, Dona Reber and Donald Singer; members of the Pharmaceutical Microbiology Expert Discussion Group
      PDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 229-248; DOI: https://doi.org/10.5731/pdajpst.2019.010546

  3. Forng, Ren-Yo

    1. Disinfectant Efficacy: Understanding the Expectations and How to Design Effective Studies That Include Leveraging Multi-Site Data to Drive an Efficient Program
      Derek Willison-Parry, Stephen Yang, Ren-Yo Forng, Tim Cirbo, Aileen Mcmeel, Brian Kiler and Christopher Phillion
      PDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 249-263; DOI: https://doi.org/10.5731/pdajpst.2018.009662

  4. Fratz-Berilla, Erica J.

    1. Bioprocess: Robustness with Respect to Mycoplasma Species
      Talia Faison, Julie Wang, Sarah Johnson, Matthew Brown, Meng-Jung Chiang, Sherri Dolan, Carl Breuning, Sai Rashmika Velugula-Yellela, Scott Lute, Erica J. Fratz-Berilla and Kurt Brorson
      PDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 201-212; DOI: https://doi.org/10.5731/pdajpst.2018.009613

H

  1. Hartman, Taymar

    1. Advancing Biologics Development Programs with Legacy Cell Lines: Advantages and Limitations of Genetic Testing for Addressing Clonality Concerns Prior to Availability of Late Stage Process and Product Consistency Data
      Paul Wu, Taymar Hartman, Louise Almond, Jennitte Stevens, John Thrift, Juhi Ojha, Christina Alves, David Shaw, Michael W. Laird, Robyn Emmins, Yuan Zhu, Ren Liu, Zhimei Du, Rolf Koehler, Thomas Jostock, Karin Anderson, Chris Campbell and Howard Clarke
      PDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 264-274; DOI: https://doi.org/10.5731/pdajpst.2018.009316

J

  1. Jenke, Dennis

    1. Identification and Quantitation Classifications for Extractables and Leachables
      Dennis Jenke
      PDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 275-285; DOI: https://doi.org/10.5731/pdajpst.2019.010538

  2. Johnson, Richard M.

    1. PDA Responds to the Novel Coronavirus Situation
      Richard M. Johnson
      PDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 170; DOI: https://doi.org/10.5731/pdajpst.2019.001118

  3. Johnson, Sarah

    1. Bioprocess: Robustness with Respect to Mycoplasma Species
      Talia Faison, Julie Wang, Sarah Johnson, Matthew Brown, Meng-Jung Chiang, Sherri Dolan, Carl Breuning, Sai Rashmika Velugula-Yellela, Scott Lute, Erica J. Fratz-Berilla and Kurt Brorson
      PDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 201-212; DOI: https://doi.org/10.5731/pdajpst.2018.009613

  4. Jostock, Thomas

    1. Advancing Biologics Development Programs with Legacy Cell Lines: Advantages and Limitations of Genetic Testing for Addressing Clonality Concerns Prior to Availability of Late Stage Process and Product Consistency Data
      Paul Wu, Taymar Hartman, Louise Almond, Jennitte Stevens, John Thrift, Juhi Ojha, Christina Alves, David Shaw, Michael W. Laird, Robyn Emmins, Yuan Zhu, Ren Liu, Zhimei Du, Rolf Koehler, Thomas Jostock, Karin Anderson, Chris Campbell and Howard Clarke
      PDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 264-274; DOI: https://doi.org/10.5731/pdajpst.2018.009316

K

  1. Kiler, Brian

    1. Disinfectant Efficacy: Understanding the Expectations and How to Design Effective Studies That Include Leveraging Multi-Site Data to Drive an Efficient Program
      Derek Willison-Parry, Stephen Yang, Ren-Yo Forng, Tim Cirbo, Aileen Mcmeel, Brian Kiler and Christopher Phillion
      PDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 249-263; DOI: https://doi.org/10.5731/pdajpst.2018.009662

  2. Koehler, Rolf

    1. Advancing Biologics Development Programs with Legacy Cell Lines: Advantages and Limitations of Genetic Testing for Addressing Clonality Concerns Prior to Availability of Late Stage Process and Product Consistency Data
      Paul Wu, Taymar Hartman, Louise Almond, Jennitte Stevens, John Thrift, Juhi Ojha, Christina Alves, David Shaw, Michael W. Laird, Robyn Emmins, Yuan Zhu, Ren Liu, Zhimei Du, Rolf Koehler, Thomas Jostock, Karin Anderson, Chris Campbell and Howard Clarke
      PDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 264-274; DOI: https://doi.org/10.5731/pdajpst.2018.009316

  3. Kolhe, Parag

    1. Control Strategy Approach for a Well-Characterized Vaccine Drug Product
      Parag Kolhe, Khurram Sunasara, Lavinia Lewis, Michele Bailey Piatchek, Roberto Rodriguez and Katherine Arch-Douglas
      PDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 213-228; DOI: https://doi.org/10.5731/pdajpst.2018.009415

L

  1. Laird, Michael W.

    1. Advancing Biologics Development Programs with Legacy Cell Lines: Advantages and Limitations of Genetic Testing for Addressing Clonality Concerns Prior to Availability of Late Stage Process and Product Consistency Data
      Paul Wu, Taymar Hartman, Louise Almond, Jennitte Stevens, John Thrift, Juhi Ojha, Christina Alves, David Shaw, Michael W. Laird, Robyn Emmins, Yuan Zhu, Ren Liu, Zhimei Du, Rolf Koehler, Thomas Jostock, Karin Anderson, Chris Campbell and Howard Clarke
      PDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 264-274; DOI: https://doi.org/10.5731/pdajpst.2018.009316

  2. Lam, Philippe

    1. Quantifying the Vial-Capping Process: Reexamination Using Micro-Computed Tomography
      Robert Ovadia, Philippe Lam, Vassia Tegoulia and Yuh-Fun Maa
      PDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 171-184; DOI: https://doi.org/10.5731/pdajpst.2019.010363

  3. Lewis, Lavinia

    1. Control Strategy Approach for a Well-Characterized Vaccine Drug Product
      Parag Kolhe, Khurram Sunasara, Lavinia Lewis, Michele Bailey Piatchek, Roberto Rodriguez and Katherine Arch-Douglas
      PDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 213-228; DOI: https://doi.org/10.5731/pdajpst.2018.009415

  4. Liu, Ren

    1. Advancing Biologics Development Programs with Legacy Cell Lines: Advantages and Limitations of Genetic Testing for Addressing Clonality Concerns Prior to Availability of Late Stage Process and Product Consistency Data
      Paul Wu, Taymar Hartman, Louise Almond, Jennitte Stevens, John Thrift, Juhi Ojha, Christina Alves, David Shaw, Michael W. Laird, Robyn Emmins, Yuan Zhu, Ren Liu, Zhimei Du, Rolf Koehler, Thomas Jostock, Karin Anderson, Chris Campbell and Howard Clarke
      PDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 264-274; DOI: https://doi.org/10.5731/pdajpst.2018.009316

  5. Lute, Scott

    1. Bioprocess: Robustness with Respect to Mycoplasma Species
      Talia Faison, Julie Wang, Sarah Johnson, Matthew Brown, Meng-Jung Chiang, Sherri Dolan, Carl Breuning, Sai Rashmika Velugula-Yellela, Scott Lute, Erica J. Fratz-Berilla and Kurt Brorson
      PDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 201-212; DOI: https://doi.org/10.5731/pdajpst.2018.009613

M

  1. Maa, Yuh-Fun

    1. Quantifying the Vial-Capping Process: Reexamination Using Micro-Computed Tomography
      Robert Ovadia, Philippe Lam, Vassia Tegoulia and Yuh-Fun Maa
      PDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 171-184; DOI: https://doi.org/10.5731/pdajpst.2019.010363

  2. Mcmeel, Aileen

    1. Disinfectant Efficacy: Understanding the Expectations and How to Design Effective Studies That Include Leveraging Multi-Site Data to Drive an Efficient Program
      Derek Willison-Parry, Stephen Yang, Ren-Yo Forng, Tim Cirbo, Aileen Mcmeel, Brian Kiler and Christopher Phillion
      PDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 249-263; DOI: https://doi.org/10.5731/pdajpst.2018.009662

O

  1. Ojha, Juhi

    1. Advancing Biologics Development Programs with Legacy Cell Lines: Advantages and Limitations of Genetic Testing for Addressing Clonality Concerns Prior to Availability of Late Stage Process and Product Consistency Data
      Paul Wu, Taymar Hartman, Louise Almond, Jennitte Stevens, John Thrift, Juhi Ojha, Christina Alves, David Shaw, Michael W. Laird, Robyn Emmins, Yuan Zhu, Ren Liu, Zhimei Du, Rolf Koehler, Thomas Jostock, Karin Anderson, Chris Campbell and Howard Clarke
      PDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 264-274; DOI: https://doi.org/10.5731/pdajpst.2018.009316

  2. Ovadia, Robert

    1. Quantifying the Vial-Capping Process: Reexamination Using Micro-Computed Tomography
      Robert Ovadia, Philippe Lam, Vassia Tegoulia and Yuh-Fun Maa
      PDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 171-184; DOI: https://doi.org/10.5731/pdajpst.2019.010363

P

  1. Panighello, Serena

    1. Investigating the Effects of the Chemical Composition on Glass Corrosion: A Case Study for Type I Vials
      Serena Panighello and Odra Pinato
      PDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 185-200; DOI: https://doi.org/10.5731/pdajpst.2019.010066

  2. Phillion, Christopher

    1. Disinfectant Efficacy: Understanding the Expectations and How to Design Effective Studies That Include Leveraging Multi-Site Data to Drive an Efficient Program
      Derek Willison-Parry, Stephen Yang, Ren-Yo Forng, Tim Cirbo, Aileen Mcmeel, Brian Kiler and Christopher Phillion
      PDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 249-263; DOI: https://doi.org/10.5731/pdajpst.2018.009662

  3. Pinato, Odra

    1. Investigating the Effects of the Chemical Composition on Glass Corrosion: A Case Study for Type I Vials
      Serena Panighello and Odra Pinato
      PDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 185-200; DOI: https://doi.org/10.5731/pdajpst.2019.010066

R

  1. Ramnarine, Emma

    1. Managing Excipient Supplier Name and Address Changes in the Pharmaceutical Quality System
      Richard Rolke, Emma Ramnarine, Anders Vinther and Anil Sawant
      PDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 286-288; DOI: https://doi.org/10.5731/pdajpst.2019.011239

  2. Reber, Dona

    1. Risk Assessment Approach to Microbiological Controls of Cell Therapies
      Tony Cundell, Scott Drummond, Irving Ford, Dona Reber and Donald Singer; members of the Pharmaceutical Microbiology Expert Discussion Group
      PDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 229-248; DOI: https://doi.org/10.5731/pdajpst.2019.010546

  3. Rodriguez, Roberto

    1. Control Strategy Approach for a Well-Characterized Vaccine Drug Product
      Parag Kolhe, Khurram Sunasara, Lavinia Lewis, Michele Bailey Piatchek, Roberto Rodriguez and Katherine Arch-Douglas
      PDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 213-228; DOI: https://doi.org/10.5731/pdajpst.2018.009415

  4. Rolke, Richard

    1. Managing Excipient Supplier Name and Address Changes in the Pharmaceutical Quality System
      Richard Rolke, Emma Ramnarine, Anders Vinther and Anil Sawant
      PDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 286-288; DOI: https://doi.org/10.5731/pdajpst.2019.011239

S

  1. Sawant, Anil

    1. Managing Excipient Supplier Name and Address Changes in the Pharmaceutical Quality System
      Richard Rolke, Emma Ramnarine, Anders Vinther and Anil Sawant
      PDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 286-288; DOI: https://doi.org/10.5731/pdajpst.2019.011239

  2. Shaw, David

    1. Advancing Biologics Development Programs with Legacy Cell Lines: Advantages and Limitations of Genetic Testing for Addressing Clonality Concerns Prior to Availability of Late Stage Process and Product Consistency Data
      Paul Wu, Taymar Hartman, Louise Almond, Jennitte Stevens, John Thrift, Juhi Ojha, Christina Alves, David Shaw, Michael W. Laird, Robyn Emmins, Yuan Zhu, Ren Liu, Zhimei Du, Rolf Koehler, Thomas Jostock, Karin Anderson, Chris Campbell and Howard Clarke
      PDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 264-274; DOI: https://doi.org/10.5731/pdajpst.2018.009316

  3. Singer, Donald

    1. Risk Assessment Approach to Microbiological Controls of Cell Therapies
      Tony Cundell, Scott Drummond, Irving Ford, Dona Reber and Donald Singer; members of the Pharmaceutical Microbiology Expert Discussion Group
      PDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 229-248; DOI: https://doi.org/10.5731/pdajpst.2019.010546

  4. Stevens, Jennitte

    1. Advancing Biologics Development Programs with Legacy Cell Lines: Advantages and Limitations of Genetic Testing for Addressing Clonality Concerns Prior to Availability of Late Stage Process and Product Consistency Data
      Paul Wu, Taymar Hartman, Louise Almond, Jennitte Stevens, John Thrift, Juhi Ojha, Christina Alves, David Shaw, Michael W. Laird, Robyn Emmins, Yuan Zhu, Ren Liu, Zhimei Du, Rolf Koehler, Thomas Jostock, Karin Anderson, Chris Campbell and Howard Clarke
      PDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 264-274; DOI: https://doi.org/10.5731/pdajpst.2018.009316

  5. Sunasara, Khurram

    1. Control Strategy Approach for a Well-Characterized Vaccine Drug Product
      Parag Kolhe, Khurram Sunasara, Lavinia Lewis, Michele Bailey Piatchek, Roberto Rodriguez and Katherine Arch-Douglas
      PDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 213-228; DOI: https://doi.org/10.5731/pdajpst.2018.009415

T

  1. Tegoulia, Vassia

    1. Quantifying the Vial-Capping Process: Reexamination Using Micro-Computed Tomography
      Robert Ovadia, Philippe Lam, Vassia Tegoulia and Yuh-Fun Maa
      PDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 171-184; DOI: https://doi.org/10.5731/pdajpst.2019.010363

  2. Thrift, John

    1. Advancing Biologics Development Programs with Legacy Cell Lines: Advantages and Limitations of Genetic Testing for Addressing Clonality Concerns Prior to Availability of Late Stage Process and Product Consistency Data
      Paul Wu, Taymar Hartman, Louise Almond, Jennitte Stevens, John Thrift, Juhi Ojha, Christina Alves, David Shaw, Michael W. Laird, Robyn Emmins, Yuan Zhu, Ren Liu, Zhimei Du, Rolf Koehler, Thomas Jostock, Karin Anderson, Chris Campbell and Howard Clarke
      PDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 264-274; DOI: https://doi.org/10.5731/pdajpst.2018.009316

V

  1. Velugula-Yellela, Sai Rashmika

    1. Bioprocess: Robustness with Respect to Mycoplasma Species
      Talia Faison, Julie Wang, Sarah Johnson, Matthew Brown, Meng-Jung Chiang, Sherri Dolan, Carl Breuning, Sai Rashmika Velugula-Yellela, Scott Lute, Erica J. Fratz-Berilla and Kurt Brorson
      PDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 201-212; DOI: https://doi.org/10.5731/pdajpst.2018.009613

  2. Vinther, Anders

    1. Managing Excipient Supplier Name and Address Changes in the Pharmaceutical Quality System
      Richard Rolke, Emma Ramnarine, Anders Vinther and Anil Sawant
      PDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 286-288; DOI: https://doi.org/10.5731/pdajpst.2019.011239

W

  1. Wang, Julie

    1. Bioprocess: Robustness with Respect to Mycoplasma Species
      Talia Faison, Julie Wang, Sarah Johnson, Matthew Brown, Meng-Jung Chiang, Sherri Dolan, Carl Breuning, Sai Rashmika Velugula-Yellela, Scott Lute, Erica J. Fratz-Berilla and Kurt Brorson
      PDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 201-212; DOI: https://doi.org/10.5731/pdajpst.2018.009613

  2. Willison-Parry, Derek

    1. Disinfectant Efficacy: Understanding the Expectations and How to Design Effective Studies That Include Leveraging Multi-Site Data to Drive an Efficient Program
      Derek Willison-Parry, Stephen Yang, Ren-Yo Forng, Tim Cirbo, Aileen Mcmeel, Brian Kiler and Christopher Phillion
      PDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 249-263; DOI: https://doi.org/10.5731/pdajpst.2018.009662

  3. Wu, Paul

    1. Advancing Biologics Development Programs with Legacy Cell Lines: Advantages and Limitations of Genetic Testing for Addressing Clonality Concerns Prior to Availability of Late Stage Process and Product Consistency Data
      Paul Wu, Taymar Hartman, Louise Almond, Jennitte Stevens, John Thrift, Juhi Ojha, Christina Alves, David Shaw, Michael W. Laird, Robyn Emmins, Yuan Zhu, Ren Liu, Zhimei Du, Rolf Koehler, Thomas Jostock, Karin Anderson, Chris Campbell and Howard Clarke
      PDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 264-274; DOI: https://doi.org/10.5731/pdajpst.2018.009316

Y

  1. Yang, Stephen

    1. Disinfectant Efficacy: Understanding the Expectations and How to Design Effective Studies That Include Leveraging Multi-Site Data to Drive an Efficient Program
      Derek Willison-Parry, Stephen Yang, Ren-Yo Forng, Tim Cirbo, Aileen Mcmeel, Brian Kiler and Christopher Phillion
      PDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 249-263; DOI: https://doi.org/10.5731/pdajpst.2018.009662

Z

  1. Zhu, Yuan

    1. Advancing Biologics Development Programs with Legacy Cell Lines: Advantages and Limitations of Genetic Testing for Addressing Clonality Concerns Prior to Availability of Late Stage Process and Product Consistency Data
      Paul Wu, Taymar Hartman, Louise Almond, Jennitte Stevens, John Thrift, Juhi Ojha, Christina Alves, David Shaw, Michael W. Laird, Robyn Emmins, Yuan Zhu, Ren Liu, Zhimei Du, Rolf Koehler, Thomas Jostock, Karin Anderson, Chris Campbell and Howard Clarke
      PDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 264-274; DOI: https://doi.org/10.5731/pdajpst.2018.009316
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