Table of Contents
March/April 2020; Volume 74,Issue 2
A
Almond, Louise
- You have accessAdvancing 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 DataPaul 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 ClarkePDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 264-274; DOI: https://doi.org/10.5731/pdajpst.2018.009316
Alves, Christina
- You have accessAdvancing 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 DataPaul 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 ClarkePDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 264-274; DOI: https://doi.org/10.5731/pdajpst.2018.009316
Anderson, Karin
- You have accessAdvancing 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 DataPaul 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 ClarkePDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 264-274; DOI: https://doi.org/10.5731/pdajpst.2018.009316
Arch-Douglas, Katherine
- You have accessControl Strategy Approach for a Well-Characterized Vaccine Drug ProductParag Kolhe, Khurram Sunasara, Lavinia Lewis, Michele Bailey Piatchek, Roberto Rodriguez and Katherine Arch-DouglasPDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 213-228; DOI: https://doi.org/10.5731/pdajpst.2018.009415
B
Bailey Piatchek, Michele
- You have accessControl Strategy Approach for a Well-Characterized Vaccine Drug ProductParag Kolhe, Khurram Sunasara, Lavinia Lewis, Michele Bailey Piatchek, Roberto Rodriguez and Katherine Arch-DouglasPDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 213-228; DOI: https://doi.org/10.5731/pdajpst.2018.009415
Breuning, Carl
- You have accessBioprocess: Robustness with Respect to Mycoplasma SpeciesTalia 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 BrorsonPDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 201-212; DOI: https://doi.org/10.5731/pdajpst.2018.009613
Brorson, Kurt
- You have accessBioprocess: Robustness with Respect to Mycoplasma SpeciesTalia 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 BrorsonPDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 201-212; DOI: https://doi.org/10.5731/pdajpst.2018.009613
Brown, Matthew
- You have accessBioprocess: Robustness with Respect to Mycoplasma SpeciesTalia 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 BrorsonPDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 201-212; DOI: https://doi.org/10.5731/pdajpst.2018.009613
C
Campbell, Chris
- You have accessAdvancing 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 DataPaul 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 ClarkePDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 264-274; DOI: https://doi.org/10.5731/pdajpst.2018.009316
Chiang, Meng-Jung
- You have accessBioprocess: Robustness with Respect to Mycoplasma SpeciesTalia 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 BrorsonPDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 201-212; DOI: https://doi.org/10.5731/pdajpst.2018.009613
Cirbo, Tim
- You have accessDisinfectant Efficacy: Understanding the Expectations and How to Design Effective Studies That Include Leveraging Multi-Site Data to Drive an Efficient ProgramDerek Willison-Parry, Stephen Yang, Ren-Yo Forng, Tim Cirbo, Aileen Mcmeel, Brian Kiler and Christopher PhillionPDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 249-263; DOI: https://doi.org/10.5731/pdajpst.2018.009662
Clarke, Howard
- You have accessAdvancing 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 DataPaul 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 ClarkePDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 264-274; DOI: https://doi.org/10.5731/pdajpst.2018.009316
Cundell, Tony
- You have accessRisk Assessment Approach to Microbiological Controls of Cell TherapiesTony Cundell, Scott Drummond, Irving Ford, Dona Reber and Donald Singer; members of the Pharmaceutical Microbiology Expert Discussion GroupPDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 229-248; DOI: https://doi.org/10.5731/pdajpst.2019.010546
D
Dolan, Sherri
- You have accessBioprocess: Robustness with Respect to Mycoplasma SpeciesTalia 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 BrorsonPDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 201-212; DOI: https://doi.org/10.5731/pdajpst.2018.009613
Drummond, Scott
- You have accessRisk Assessment Approach to Microbiological Controls of Cell TherapiesTony Cundell, Scott Drummond, Irving Ford, Dona Reber and Donald Singer; members of the Pharmaceutical Microbiology Expert Discussion GroupPDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 229-248; DOI: https://doi.org/10.5731/pdajpst.2019.010546
Du, Zhimei
- You have accessAdvancing 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 DataPaul 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 ClarkePDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 264-274; DOI: https://doi.org/10.5731/pdajpst.2018.009316
E
Emmins, Robyn
- You have accessAdvancing 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 DataPaul 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 ClarkePDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 264-274; DOI: https://doi.org/10.5731/pdajpst.2018.009316
F
Faison, Talia
- You have accessBioprocess: Robustness with Respect to Mycoplasma SpeciesTalia 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 BrorsonPDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 201-212; DOI: https://doi.org/10.5731/pdajpst.2018.009613
Ford, Irving
- You have accessRisk Assessment Approach to Microbiological Controls of Cell TherapiesTony Cundell, Scott Drummond, Irving Ford, Dona Reber and Donald Singer; members of the Pharmaceutical Microbiology Expert Discussion GroupPDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 229-248; DOI: https://doi.org/10.5731/pdajpst.2019.010546
Forng, Ren-Yo
- You have accessDisinfectant Efficacy: Understanding the Expectations and How to Design Effective Studies That Include Leveraging Multi-Site Data to Drive an Efficient ProgramDerek Willison-Parry, Stephen Yang, Ren-Yo Forng, Tim Cirbo, Aileen Mcmeel, Brian Kiler and Christopher PhillionPDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 249-263; DOI: https://doi.org/10.5731/pdajpst.2018.009662
Fratz-Berilla, Erica J.
- You have accessBioprocess: Robustness with Respect to Mycoplasma SpeciesTalia 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 BrorsonPDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 201-212; DOI: https://doi.org/10.5731/pdajpst.2018.009613
H
Hartman, Taymar
- You have accessAdvancing 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 DataPaul 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 ClarkePDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 264-274; DOI: https://doi.org/10.5731/pdajpst.2018.009316
J
Jenke, Dennis
- You have accessIdentification and Quantitation Classifications for Extractables and LeachablesDennis JenkePDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 275-285; DOI: https://doi.org/10.5731/pdajpst.2019.010538
Johnson, Richard M.
- You have accessPDA Responds to the Novel Coronavirus SituationRichard M. JohnsonPDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 170; DOI: https://doi.org/10.5731/pdajpst.2019.001118
Johnson, Sarah
- You have accessBioprocess: Robustness with Respect to Mycoplasma SpeciesTalia 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 BrorsonPDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 201-212; DOI: https://doi.org/10.5731/pdajpst.2018.009613
Jostock, Thomas
- You have accessAdvancing 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 DataPaul 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 ClarkePDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 264-274; DOI: https://doi.org/10.5731/pdajpst.2018.009316
K
Kiler, Brian
- You have accessDisinfectant Efficacy: Understanding the Expectations and How to Design Effective Studies That Include Leveraging Multi-Site Data to Drive an Efficient ProgramDerek Willison-Parry, Stephen Yang, Ren-Yo Forng, Tim Cirbo, Aileen Mcmeel, Brian Kiler and Christopher PhillionPDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 249-263; DOI: https://doi.org/10.5731/pdajpst.2018.009662
Koehler, Rolf
- You have accessAdvancing 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 DataPaul 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 ClarkePDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 264-274; DOI: https://doi.org/10.5731/pdajpst.2018.009316
Kolhe, Parag
- You have accessControl Strategy Approach for a Well-Characterized Vaccine Drug ProductParag Kolhe, Khurram Sunasara, Lavinia Lewis, Michele Bailey Piatchek, Roberto Rodriguez and Katherine Arch-DouglasPDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 213-228; DOI: https://doi.org/10.5731/pdajpst.2018.009415
L
Laird, Michael W.
- You have accessAdvancing 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 DataPaul 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 ClarkePDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 264-274; DOI: https://doi.org/10.5731/pdajpst.2018.009316
Lam, Philippe
- You have accessQuantifying the Vial-Capping Process: Reexamination Using Micro-Computed TomographyRobert Ovadia, Philippe Lam, Vassia Tegoulia and Yuh-Fun MaaPDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 171-184; DOI: https://doi.org/10.5731/pdajpst.2019.010363
Lewis, Lavinia
- You have accessControl Strategy Approach for a Well-Characterized Vaccine Drug ProductParag Kolhe, Khurram Sunasara, Lavinia Lewis, Michele Bailey Piatchek, Roberto Rodriguez and Katherine Arch-DouglasPDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 213-228; DOI: https://doi.org/10.5731/pdajpst.2018.009415
Liu, Ren
- You have accessAdvancing 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 DataPaul 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 ClarkePDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 264-274; DOI: https://doi.org/10.5731/pdajpst.2018.009316
Lute, Scott
- You have accessBioprocess: Robustness with Respect to Mycoplasma SpeciesTalia 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 BrorsonPDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 201-212; DOI: https://doi.org/10.5731/pdajpst.2018.009613
M
Maa, Yuh-Fun
- You have accessQuantifying the Vial-Capping Process: Reexamination Using Micro-Computed TomographyRobert Ovadia, Philippe Lam, Vassia Tegoulia and Yuh-Fun MaaPDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 171-184; DOI: https://doi.org/10.5731/pdajpst.2019.010363
Mcmeel, Aileen
- You have accessDisinfectant Efficacy: Understanding the Expectations and How to Design Effective Studies That Include Leveraging Multi-Site Data to Drive an Efficient ProgramDerek Willison-Parry, Stephen Yang, Ren-Yo Forng, Tim Cirbo, Aileen Mcmeel, Brian Kiler and Christopher PhillionPDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 249-263; DOI: https://doi.org/10.5731/pdajpst.2018.009662
O
Ojha, Juhi
- You have accessAdvancing 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 DataPaul 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 ClarkePDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 264-274; DOI: https://doi.org/10.5731/pdajpst.2018.009316
Ovadia, Robert
- You have accessQuantifying the Vial-Capping Process: Reexamination Using Micro-Computed TomographyRobert Ovadia, Philippe Lam, Vassia Tegoulia and Yuh-Fun MaaPDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 171-184; DOI: https://doi.org/10.5731/pdajpst.2019.010363
P
Panighello, Serena
- You have accessInvestigating the Effects of the Chemical Composition on Glass Corrosion: A Case Study for Type I VialsSerena Panighello and Odra PinatoPDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 185-200; DOI: https://doi.org/10.5731/pdajpst.2019.010066
Phillion, Christopher
- You have accessDisinfectant Efficacy: Understanding the Expectations and How to Design Effective Studies That Include Leveraging Multi-Site Data to Drive an Efficient ProgramDerek Willison-Parry, Stephen Yang, Ren-Yo Forng, Tim Cirbo, Aileen Mcmeel, Brian Kiler and Christopher PhillionPDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 249-263; DOI: https://doi.org/10.5731/pdajpst.2018.009662
Pinato, Odra
- You have accessInvestigating the Effects of the Chemical Composition on Glass Corrosion: A Case Study for Type I VialsSerena Panighello and Odra PinatoPDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 185-200; DOI: https://doi.org/10.5731/pdajpst.2019.010066
R
Ramnarine, Emma
- You have accessManaging Excipient Supplier Name and Address Changes in the Pharmaceutical Quality SystemRichard Rolke, Emma Ramnarine, Anders Vinther and Anil SawantPDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 286-288; DOI: https://doi.org/10.5731/pdajpst.2019.011239
Reber, Dona
- You have accessRisk Assessment Approach to Microbiological Controls of Cell TherapiesTony Cundell, Scott Drummond, Irving Ford, Dona Reber and Donald Singer; members of the Pharmaceutical Microbiology Expert Discussion GroupPDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 229-248; DOI: https://doi.org/10.5731/pdajpst.2019.010546
Rodriguez, Roberto
- You have accessControl Strategy Approach for a Well-Characterized Vaccine Drug ProductParag Kolhe, Khurram Sunasara, Lavinia Lewis, Michele Bailey Piatchek, Roberto Rodriguez and Katherine Arch-DouglasPDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 213-228; DOI: https://doi.org/10.5731/pdajpst.2018.009415
Rolke, Richard
- You have accessManaging Excipient Supplier Name and Address Changes in the Pharmaceutical Quality SystemRichard Rolke, Emma Ramnarine, Anders Vinther and Anil SawantPDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 286-288; DOI: https://doi.org/10.5731/pdajpst.2019.011239
S
Sawant, Anil
- You have accessManaging Excipient Supplier Name and Address Changes in the Pharmaceutical Quality SystemRichard Rolke, Emma Ramnarine, Anders Vinther and Anil SawantPDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 286-288; DOI: https://doi.org/10.5731/pdajpst.2019.011239
Shaw, David
- You have accessAdvancing 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 DataPaul 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 ClarkePDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 264-274; DOI: https://doi.org/10.5731/pdajpst.2018.009316
Singer, Donald
- You have accessRisk Assessment Approach to Microbiological Controls of Cell TherapiesTony Cundell, Scott Drummond, Irving Ford, Dona Reber and Donald Singer; members of the Pharmaceutical Microbiology Expert Discussion GroupPDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 229-248; DOI: https://doi.org/10.5731/pdajpst.2019.010546
Stevens, Jennitte
- You have accessAdvancing 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 DataPaul 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 ClarkePDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 264-274; DOI: https://doi.org/10.5731/pdajpst.2018.009316
Sunasara, Khurram
- You have accessControl Strategy Approach for a Well-Characterized Vaccine Drug ProductParag Kolhe, Khurram Sunasara, Lavinia Lewis, Michele Bailey Piatchek, Roberto Rodriguez and Katherine Arch-DouglasPDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 213-228; DOI: https://doi.org/10.5731/pdajpst.2018.009415
T
Tegoulia, Vassia
- You have accessQuantifying the Vial-Capping Process: Reexamination Using Micro-Computed TomographyRobert Ovadia, Philippe Lam, Vassia Tegoulia and Yuh-Fun MaaPDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 171-184; DOI: https://doi.org/10.5731/pdajpst.2019.010363
Thrift, John
- You have accessAdvancing 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 DataPaul 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 ClarkePDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 264-274; DOI: https://doi.org/10.5731/pdajpst.2018.009316
V
Velugula-Yellela, Sai Rashmika
- You have accessBioprocess: Robustness with Respect to Mycoplasma SpeciesTalia 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 BrorsonPDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 201-212; DOI: https://doi.org/10.5731/pdajpst.2018.009613
Vinther, Anders
- You have accessManaging Excipient Supplier Name and Address Changes in the Pharmaceutical Quality SystemRichard Rolke, Emma Ramnarine, Anders Vinther and Anil SawantPDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 286-288; DOI: https://doi.org/10.5731/pdajpst.2019.011239
W
Wang, Julie
- You have accessBioprocess: Robustness with Respect to Mycoplasma SpeciesTalia 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 BrorsonPDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 201-212; DOI: https://doi.org/10.5731/pdajpst.2018.009613
Willison-Parry, Derek
- You have accessDisinfectant Efficacy: Understanding the Expectations and How to Design Effective Studies That Include Leveraging Multi-Site Data to Drive an Efficient ProgramDerek Willison-Parry, Stephen Yang, Ren-Yo Forng, Tim Cirbo, Aileen Mcmeel, Brian Kiler and Christopher PhillionPDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 249-263; DOI: https://doi.org/10.5731/pdajpst.2018.009662
Wu, Paul
- You have accessAdvancing 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 DataPaul 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 ClarkePDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 264-274; DOI: https://doi.org/10.5731/pdajpst.2018.009316
Y
Yang, Stephen
- You have accessDisinfectant Efficacy: Understanding the Expectations and How to Design Effective Studies That Include Leveraging Multi-Site Data to Drive an Efficient ProgramDerek Willison-Parry, Stephen Yang, Ren-Yo Forng, Tim Cirbo, Aileen Mcmeel, Brian Kiler and Christopher PhillionPDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 249-263; DOI: https://doi.org/10.5731/pdajpst.2018.009662
Z
Zhu, Yuan
- You have accessAdvancing 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 DataPaul 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 ClarkePDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 264-274; DOI: https://doi.org/10.5731/pdajpst.2018.009316
In This Issue
PDA Journal of Pharmaceutical Science and Technology
Vol. 74, Issue 2
March/April 2020
