Table of Contents

May/June 2015; Volume 69,Issue 3

A

  1. Adler, Stefanie

    1. White Paper: Container Closure Integrity Control versus Integrity Testing during Routine Manufacturing
      Scott Ewan, Min Jiang, Chris Stevenson, Olivia Henderson, Steve Klohr, Martha Wessel, Pinky Mehta, Stefanie Adler, Cindy Lake, John Walsh, Tony Polomene and Valja Everaert
      PDA Journal of Pharmaceutical Science and Technology May 2015, 69 (3) 461-465; DOI: https://doi.org/10.5731/pdajpst.2015.01071

  2. Arbesser-Rastburg, Christine

    1. Microbial Monitoring For Biological Drug Substance Manufacturing: An Industry Perspective
      David Bain, Diane Hardy, Brian L. Bell, Ren-Yo Forng, Michael Knight, Anita Bawa, Stephanie Ramsey, Christine Arbesser-Rastburg, Mousumi Paul, Christopher Ton, Fran Leira, Claudia Roman, Kim McFarland, David Phillips, Jean Stuckey, Christian Bauer and Andres J. Calvo
      PDA Journal of Pharmaceutical Science and Technology May 2015, 69 (3) 451-460; DOI: https://doi.org/10.5731/pdajpst.2015.01070

B

  1. Bain, David

    1. Microbial Monitoring For Biological Drug Substance Manufacturing: An Industry Perspective
      David Bain, Diane Hardy, Brian L. Bell, Ren-Yo Forng, Michael Knight, Anita Bawa, Stephanie Ramsey, Christine Arbesser-Rastburg, Mousumi Paul, Christopher Ton, Fran Leira, Claudia Roman, Kim McFarland, David Phillips, Jean Stuckey, Christian Bauer and Andres J. Calvo
      PDA Journal of Pharmaceutical Science and Technology May 2015, 69 (3) 451-460; DOI: https://doi.org/10.5731/pdajpst.2015.01070

  2. Bauer, Christian

    1. Microbial Monitoring For Biological Drug Substance Manufacturing: An Industry Perspective
      David Bain, Diane Hardy, Brian L. Bell, Ren-Yo Forng, Michael Knight, Anita Bawa, Stephanie Ramsey, Christine Arbesser-Rastburg, Mousumi Paul, Christopher Ton, Fran Leira, Claudia Roman, Kim McFarland, David Phillips, Jean Stuckey, Christian Bauer and Andres J. Calvo
      PDA Journal of Pharmaceutical Science and Technology May 2015, 69 (3) 451-460; DOI: https://doi.org/10.5731/pdajpst.2015.01070

  3. Bawa, Anita

    1. Microbial Monitoring For Biological Drug Substance Manufacturing: An Industry Perspective
      David Bain, Diane Hardy, Brian L. Bell, Ren-Yo Forng, Michael Knight, Anita Bawa, Stephanie Ramsey, Christine Arbesser-Rastburg, Mousumi Paul, Christopher Ton, Fran Leira, Claudia Roman, Kim McFarland, David Phillips, Jean Stuckey, Christian Bauer and Andres J. Calvo
      PDA Journal of Pharmaceutical Science and Technology May 2015, 69 (3) 451-460; DOI: https://doi.org/10.5731/pdajpst.2015.01070

  4. Beldarraín, Alejandro

    1. Stability Studies of a Freeze-Dried Recombinant Human Epidermal Growth Factor Formulation for Wound Healing
      Héctor Santana, Gerardo García, Maribel Vega, Alejandro Beldarraín and Rolando Páez
      PDA Journal of Pharmaceutical Science and Technology May 2015, 69 (3) 399-416; DOI: https://doi.org/10.5731/pdajpst.2015.01052

  5. Bell, Brian L.

    1. Microbial Monitoring For Biological Drug Substance Manufacturing: An Industry Perspective
      David Bain, Diane Hardy, Brian L. Bell, Ren-Yo Forng, Michael Knight, Anita Bawa, Stephanie Ramsey, Christine Arbesser-Rastburg, Mousumi Paul, Christopher Ton, Fran Leira, Claudia Roman, Kim McFarland, David Phillips, Jean Stuckey, Christian Bauer and Andres J. Calvo
      PDA Journal of Pharmaceutical Science and Technology May 2015, 69 (3) 451-460; DOI: https://doi.org/10.5731/pdajpst.2015.01070

  6. Bjerke, Trude Marie

    1. Physicochemical Stability of Emulsions and Admixtures for Parenteral Nutrition during Irradiation by Glass-Filtered Daylight at Standardized Conditions
      Marianne Lilletvedt Tovsen, Gro Smistad, Trude Marie Bjerke, Hanne Hjorth Tønnesen and Solveig Kristensen
      PDA Journal of Pharmaceutical Science and Technology May 2015, 69 (3) 346-354; DOI: https://doi.org/10.5731/pdajpst.2015.01036

  7. Bogseth, Roy

    1. A Means of Establishing and Justifying Binary Ethanol/Water Mixtures as Simulating Solvents in Extractables Studies
      Dennis Jenke, Norman Liu, Yousheng Hua, Steven Swanson and Roy Bogseth
      PDA Journal of Pharmaceutical Science and Technology May 2015, 69 (3) 366-382; DOI: https://doi.org/10.5731/pdajpst.2015.01046

C

  1. Calvo, Andres J.

    1. Microbial Monitoring For Biological Drug Substance Manufacturing: An Industry Perspective
      David Bain, Diane Hardy, Brian L. Bell, Ren-Yo Forng, Michael Knight, Anita Bawa, Stephanie Ramsey, Christine Arbesser-Rastburg, Mousumi Paul, Christopher Ton, Fran Leira, Claudia Roman, Kim McFarland, David Phillips, Jean Stuckey, Christian Bauer and Andres J. Calvo
      PDA Journal of Pharmaceutical Science and Technology May 2015, 69 (3) 451-460; DOI: https://doi.org/10.5731/pdajpst.2015.01070

  2. Cho, Seok-Jun

    1. Microscopic Characterization of Brevundimonas diminuta in the Hydrated State
      Gary Harp, Seok-Jun Cho, Elisabeth Lester, David Rose, Chandran Sabanyagam and Scott F. Ross
      PDA Journal of Pharmaceutical Science and Technology May 2015, 69 (3) 355-365; DOI: https://doi.org/10.5731/pdajpst.2015.01045

D

  1. De Vilmorin, Philippe

    1. Achieving a Successful Scale-Down Model and Optimized Economics through Parvovirus Filter Validation using Purified TrueSpikeTM Viruses
      Philippe De Vilmorin, Ashley Slocum, Tareq Jaber, Oliver Schaefer, Horst Ruppach and Paul Genest
      PDA Journal of Pharmaceutical Science and Technology May 2015, 69 (3) 440-449; DOI: https://doi.org/10.5731/pdajpst.2015.01054

E

  1. Everaert, Valja

    1. White Paper: Container Closure Integrity Control versus Integrity Testing during Routine Manufacturing
      Scott Ewan, Min Jiang, Chris Stevenson, Olivia Henderson, Steve Klohr, Martha Wessel, Pinky Mehta, Stefanie Adler, Cindy Lake, John Walsh, Tony Polomene and Valja Everaert
      PDA Journal of Pharmaceutical Science and Technology May 2015, 69 (3) 461-465; DOI: https://doi.org/10.5731/pdajpst.2015.01071

  2. Ewan, Scott

    1. White Paper: Container Closure Integrity Control versus Integrity Testing during Routine Manufacturing
      Scott Ewan, Min Jiang, Chris Stevenson, Olivia Henderson, Steve Klohr, Martha Wessel, Pinky Mehta, Stefanie Adler, Cindy Lake, John Walsh, Tony Polomene and Valja Everaert
      PDA Journal of Pharmaceutical Science and Technology May 2015, 69 (3) 461-465; DOI: https://doi.org/10.5731/pdajpst.2015.01071

F

  1. Forng, Ren-Yo

    1. Microbial Monitoring For Biological Drug Substance Manufacturing: An Industry Perspective
      David Bain, Diane Hardy, Brian L. Bell, Ren-Yo Forng, Michael Knight, Anita Bawa, Stephanie Ramsey, Christine Arbesser-Rastburg, Mousumi Paul, Christopher Ton, Fran Leira, Claudia Roman, Kim McFarland, David Phillips, Jean Stuckey, Christian Bauer and Andres J. Calvo
      PDA Journal of Pharmaceutical Science and Technology May 2015, 69 (3) 451-460; DOI: https://doi.org/10.5731/pdajpst.2015.01070

G

  1. García, Gerardo

    1. Stability Studies of a Freeze-Dried Recombinant Human Epidermal Growth Factor Formulation for Wound Healing
      Héctor Santana, Gerardo García, Maribel Vega, Alejandro Beldarraín and Rolando Páez
      PDA Journal of Pharmaceutical Science and Technology May 2015, 69 (3) 399-416; DOI: https://doi.org/10.5731/pdajpst.2015.01052

  2. Genest, Paul

    1. Achieving a Successful Scale-Down Model and Optimized Economics through Parvovirus Filter Validation using Purified TrueSpikeTM Viruses
      Philippe De Vilmorin, Ashley Slocum, Tareq Jaber, Oliver Schaefer, Horst Ruppach and Paul Genest
      PDA Journal of Pharmaceutical Science and Technology May 2015, 69 (3) 440-449; DOI: https://doi.org/10.5731/pdajpst.2015.01054

  3. Gordon, Oliver

    1. Comparison of Different Calculation Approaches for Defining Microbiological Control Levels Based on Historical Data
      Oliver Gordon, Marcel Goverde, James Pazdan, Alexandra Staerk and David Roesti
      PDA Journal of Pharmaceutical Science and Technology May 2015, 69 (3) 383-398; DOI: https://doi.org/10.5731/pdajpst.2015.01050

  4. Goverde, Marcel

    1. Comparison of Different Calculation Approaches for Defining Microbiological Control Levels Based on Historical Data
      Oliver Gordon, Marcel Goverde, James Pazdan, Alexandra Staerk and David Roesti
      PDA Journal of Pharmaceutical Science and Technology May 2015, 69 (3) 383-398; DOI: https://doi.org/10.5731/pdajpst.2015.01050

  5. Gruia, Flaviu

    1. Practical Considerations for Detection and Characterization of Sub-Micron Particles in Protein Solutions by Nanoparticle Tracking Analysis
      Flaviu Gruia, Arun Parupudi and Alla Polozova
      PDA Journal of Pharmaceutical Science and Technology May 2015, 69 (3) 427-439; DOI: https://doi.org/10.5731/pdajpst.2015.01051

H

  1. Hardy, Diane

    1. Microbial Monitoring For Biological Drug Substance Manufacturing: An Industry Perspective
      David Bain, Diane Hardy, Brian L. Bell, Ren-Yo Forng, Michael Knight, Anita Bawa, Stephanie Ramsey, Christine Arbesser-Rastburg, Mousumi Paul, Christopher Ton, Fran Leira, Claudia Roman, Kim McFarland, David Phillips, Jean Stuckey, Christian Bauer and Andres J. Calvo
      PDA Journal of Pharmaceutical Science and Technology May 2015, 69 (3) 451-460; DOI: https://doi.org/10.5731/pdajpst.2015.01070

  2. Harp, Gary

    1. Microscopic Characterization of Brevundimonas diminuta in the Hydrated State
      Gary Harp, Seok-Jun Cho, Elisabeth Lester, David Rose, Chandran Sabanyagam and Scott F. Ross
      PDA Journal of Pharmaceutical Science and Technology May 2015, 69 (3) 355-365; DOI: https://doi.org/10.5731/pdajpst.2015.01045

  3. Henderson, Olivia

    1. White Paper: Container Closure Integrity Control versus Integrity Testing during Routine Manufacturing
      Scott Ewan, Min Jiang, Chris Stevenson, Olivia Henderson, Steve Klohr, Martha Wessel, Pinky Mehta, Stefanie Adler, Cindy Lake, John Walsh, Tony Polomene and Valja Everaert
      PDA Journal of Pharmaceutical Science and Technology May 2015, 69 (3) 461-465; DOI: https://doi.org/10.5731/pdajpst.2015.01071

  4. Hua, Yousheng

    1. A Means of Establishing and Justifying Binary Ethanol/Water Mixtures as Simulating Solvents in Extractables Studies
      Dennis Jenke, Norman Liu, Yousheng Hua, Steven Swanson and Roy Bogseth
      PDA Journal of Pharmaceutical Science and Technology May 2015, 69 (3) 366-382; DOI: https://doi.org/10.5731/pdajpst.2015.01046

J

  1. Jaber, Tareq

    1. Achieving a Successful Scale-Down Model and Optimized Economics through Parvovirus Filter Validation using Purified TrueSpikeTM Viruses
      Philippe De Vilmorin, Ashley Slocum, Tareq Jaber, Oliver Schaefer, Horst Ruppach and Paul Genest
      PDA Journal of Pharmaceutical Science and Technology May 2015, 69 (3) 440-449; DOI: https://doi.org/10.5731/pdajpst.2015.01054

  2. Jenke, Dennis

    1. A Means of Establishing and Justifying Binary Ethanol/Water Mixtures as Simulating Solvents in Extractables Studies
      Dennis Jenke, Norman Liu, Yousheng Hua, Steven Swanson and Roy Bogseth
      PDA Journal of Pharmaceutical Science and Technology May 2015, 69 (3) 366-382; DOI: https://doi.org/10.5731/pdajpst.2015.01046

  3. Jiang, Min

    1. White Paper: Container Closure Integrity Control versus Integrity Testing during Routine Manufacturing
      Scott Ewan, Min Jiang, Chris Stevenson, Olivia Henderson, Steve Klohr, Martha Wessel, Pinky Mehta, Stefanie Adler, Cindy Lake, John Walsh, Tony Polomene and Valja Everaert
      PDA Journal of Pharmaceutical Science and Technology May 2015, 69 (3) 461-465; DOI: https://doi.org/10.5731/pdajpst.2015.01071

K

  1. Klohr, Steve

    1. White Paper: Container Closure Integrity Control versus Integrity Testing during Routine Manufacturing
      Scott Ewan, Min Jiang, Chris Stevenson, Olivia Henderson, Steve Klohr, Martha Wessel, Pinky Mehta, Stefanie Adler, Cindy Lake, John Walsh, Tony Polomene and Valja Everaert
      PDA Journal of Pharmaceutical Science and Technology May 2015, 69 (3) 461-465; DOI: https://doi.org/10.5731/pdajpst.2015.01071

  2. Knight, Michael

    1. Microbial Monitoring For Biological Drug Substance Manufacturing: An Industry Perspective
      David Bain, Diane Hardy, Brian L. Bell, Ren-Yo Forng, Michael Knight, Anita Bawa, Stephanie Ramsey, Christine Arbesser-Rastburg, Mousumi Paul, Christopher Ton, Fran Leira, Claudia Roman, Kim McFarland, David Phillips, Jean Stuckey, Christian Bauer and Andres J. Calvo
      PDA Journal of Pharmaceutical Science and Technology May 2015, 69 (3) 451-460; DOI: https://doi.org/10.5731/pdajpst.2015.01070

  3. Kristensen, Solveig

    1. Physicochemical Stability of Emulsions and Admixtures for Parenteral Nutrition during Irradiation by Glass-Filtered Daylight at Standardized Conditions
      Marianne Lilletvedt Tovsen, Gro Smistad, Trude Marie Bjerke, Hanne Hjorth Tønnesen and Solveig Kristensen
      PDA Journal of Pharmaceutical Science and Technology May 2015, 69 (3) 346-354; DOI: https://doi.org/10.5731/pdajpst.2015.01036

L

  1. Lake, Cindy

    1. White Paper: Container Closure Integrity Control versus Integrity Testing during Routine Manufacturing
      Scott Ewan, Min Jiang, Chris Stevenson, Olivia Henderson, Steve Klohr, Martha Wessel, Pinky Mehta, Stefanie Adler, Cindy Lake, John Walsh, Tony Polomene and Valja Everaert
      PDA Journal of Pharmaceutical Science and Technology May 2015, 69 (3) 461-465; DOI: https://doi.org/10.5731/pdajpst.2015.01071

  2. Leira, Fran

    1. Microbial Monitoring For Biological Drug Substance Manufacturing: An Industry Perspective
      David Bain, Diane Hardy, Brian L. Bell, Ren-Yo Forng, Michael Knight, Anita Bawa, Stephanie Ramsey, Christine Arbesser-Rastburg, Mousumi Paul, Christopher Ton, Fran Leira, Claudia Roman, Kim McFarland, David Phillips, Jean Stuckey, Christian Bauer and Andres J. Calvo
      PDA Journal of Pharmaceutical Science and Technology May 2015, 69 (3) 451-460; DOI: https://doi.org/10.5731/pdajpst.2015.01070

  3. Lester, Elisabeth

    1. Microscopic Characterization of Brevundimonas diminuta in the Hydrated State
      Gary Harp, Seok-Jun Cho, Elisabeth Lester, David Rose, Chandran Sabanyagam and Scott F. Ross
      PDA Journal of Pharmaceutical Science and Technology May 2015, 69 (3) 355-365; DOI: https://doi.org/10.5731/pdajpst.2015.01045

  4. Li, Kim

    1. Risk-based Strategy to Determine Testing Requirement for the Removal of Residual Process Reagents as Process-related Impurities in Bioprocesses
      Jinshu Qiu, Kim Li, Karen Miller and Anil Raghani
      PDA Journal of Pharmaceutical Science and Technology May 2015, 69 (3) 334-345; DOI: https://doi.org/10.5731/pdajpst.2015.01056

  5. Liu, Norman

    1. A Means of Establishing and Justifying Binary Ethanol/Water Mixtures as Simulating Solvents in Extractables Studies
      Dennis Jenke, Norman Liu, Yousheng Hua, Steven Swanson and Roy Bogseth
      PDA Journal of Pharmaceutical Science and Technology May 2015, 69 (3) 366-382; DOI: https://doi.org/10.5731/pdajpst.2015.01046

M

  1. Maa, Yuh-Fun

    1. Filling of High-Concentration Monoclonal Antibody Formulations into Pre-filled Syringes: Investigating Formulation-Nozzle Interactions To Minimize Nozzle Clogging
      Wendy Shieu, Oliver B. Stauch and Yuh-Fun Maa
      PDA Journal of Pharmaceutical Science and Technology May 2015, 69 (3) 417-426; DOI: https://doi.org/10.5731/pdajpst.2015.01055

  2. McFarland, Kim

    1. Microbial Monitoring For Biological Drug Substance Manufacturing: An Industry Perspective
      David Bain, Diane Hardy, Brian L. Bell, Ren-Yo Forng, Michael Knight, Anita Bawa, Stephanie Ramsey, Christine Arbesser-Rastburg, Mousumi Paul, Christopher Ton, Fran Leira, Claudia Roman, Kim McFarland, David Phillips, Jean Stuckey, Christian Bauer and Andres J. Calvo
      PDA Journal of Pharmaceutical Science and Technology May 2015, 69 (3) 451-460; DOI: https://doi.org/10.5731/pdajpst.2015.01070

  3. Mehta, Pinky

    1. White Paper: Container Closure Integrity Control versus Integrity Testing during Routine Manufacturing
      Scott Ewan, Min Jiang, Chris Stevenson, Olivia Henderson, Steve Klohr, Martha Wessel, Pinky Mehta, Stefanie Adler, Cindy Lake, John Walsh, Tony Polomene and Valja Everaert
      PDA Journal of Pharmaceutical Science and Technology May 2015, 69 (3) 461-465; DOI: https://doi.org/10.5731/pdajpst.2015.01071

  4. Miller, Karen

    1. Risk-based Strategy to Determine Testing Requirement for the Removal of Residual Process Reagents as Process-related Impurities in Bioprocesses
      Jinshu Qiu, Kim Li, Karen Miller and Anil Raghani
      PDA Journal of Pharmaceutical Science and Technology May 2015, 69 (3) 334-345; DOI: https://doi.org/10.5731/pdajpst.2015.01056

P

  1. Páez, Rolando

    1. Stability Studies of a Freeze-Dried Recombinant Human Epidermal Growth Factor Formulation for Wound Healing
      Héctor Santana, Gerardo García, Maribel Vega, Alejandro Beldarraín and Rolando Páez
      PDA Journal of Pharmaceutical Science and Technology May 2015, 69 (3) 399-416; DOI: https://doi.org/10.5731/pdajpst.2015.01052

  2. Parupudi, Arun

    1. Practical Considerations for Detection and Characterization of Sub-Micron Particles in Protein Solutions by Nanoparticle Tracking Analysis
      Flaviu Gruia, Arun Parupudi and Alla Polozova
      PDA Journal of Pharmaceutical Science and Technology May 2015, 69 (3) 427-439; DOI: https://doi.org/10.5731/pdajpst.2015.01051

  3. Paul, Mousumi

    1. Microbial Monitoring For Biological Drug Substance Manufacturing: An Industry Perspective
      David Bain, Diane Hardy, Brian L. Bell, Ren-Yo Forng, Michael Knight, Anita Bawa, Stephanie Ramsey, Christine Arbesser-Rastburg, Mousumi Paul, Christopher Ton, Fran Leira, Claudia Roman, Kim McFarland, David Phillips, Jean Stuckey, Christian Bauer and Andres J. Calvo
      PDA Journal of Pharmaceutical Science and Technology May 2015, 69 (3) 451-460; DOI: https://doi.org/10.5731/pdajpst.2015.01070

  4. Pazdan, James

    1. Comparison of Different Calculation Approaches for Defining Microbiological Control Levels Based on Historical Data
      Oliver Gordon, Marcel Goverde, James Pazdan, Alexandra Staerk and David Roesti
      PDA Journal of Pharmaceutical Science and Technology May 2015, 69 (3) 383-398; DOI: https://doi.org/10.5731/pdajpst.2015.01050

  5. Phillips, David

    1. Microbial Monitoring For Biological Drug Substance Manufacturing: An Industry Perspective
      David Bain, Diane Hardy, Brian L. Bell, Ren-Yo Forng, Michael Knight, Anita Bawa, Stephanie Ramsey, Christine Arbesser-Rastburg, Mousumi Paul, Christopher Ton, Fran Leira, Claudia Roman, Kim McFarland, David Phillips, Jean Stuckey, Christian Bauer and Andres J. Calvo
      PDA Journal of Pharmaceutical Science and Technology May 2015, 69 (3) 451-460; DOI: https://doi.org/10.5731/pdajpst.2015.01070

  6. Polomene, Tony

    1. White Paper: Container Closure Integrity Control versus Integrity Testing during Routine Manufacturing
      Scott Ewan, Min Jiang, Chris Stevenson, Olivia Henderson, Steve Klohr, Martha Wessel, Pinky Mehta, Stefanie Adler, Cindy Lake, John Walsh, Tony Polomene and Valja Everaert
      PDA Journal of Pharmaceutical Science and Technology May 2015, 69 (3) 461-465; DOI: https://doi.org/10.5731/pdajpst.2015.01071

  7. Polozova, Alla

    1. Practical Considerations for Detection and Characterization of Sub-Micron Particles in Protein Solutions by Nanoparticle Tracking Analysis
      Flaviu Gruia, Arun Parupudi and Alla Polozova
      PDA Journal of Pharmaceutical Science and Technology May 2015, 69 (3) 427-439; DOI: https://doi.org/10.5731/pdajpst.2015.01051

Q

  1. Qiu, Jinshu

    1. Risk-based Strategy to Determine Testing Requirement for the Removal of Residual Process Reagents as Process-related Impurities in Bioprocesses
      Jinshu Qiu, Kim Li, Karen Miller and Anil Raghani
      PDA Journal of Pharmaceutical Science and Technology May 2015, 69 (3) 334-345; DOI: https://doi.org/10.5731/pdajpst.2015.01056

R

  1. Raghani, Anil

    1. Risk-based Strategy to Determine Testing Requirement for the Removal of Residual Process Reagents as Process-related Impurities in Bioprocesses
      Jinshu Qiu, Kim Li, Karen Miller and Anil Raghani
      PDA Journal of Pharmaceutical Science and Technology May 2015, 69 (3) 334-345; DOI: https://doi.org/10.5731/pdajpst.2015.01056

  2. Ramsey, Stephanie

    1. Microbial Monitoring For Biological Drug Substance Manufacturing: An Industry Perspective
      David Bain, Diane Hardy, Brian L. Bell, Ren-Yo Forng, Michael Knight, Anita Bawa, Stephanie Ramsey, Christine Arbesser-Rastburg, Mousumi Paul, Christopher Ton, Fran Leira, Claudia Roman, Kim McFarland, David Phillips, Jean Stuckey, Christian Bauer and Andres J. Calvo
      PDA Journal of Pharmaceutical Science and Technology May 2015, 69 (3) 451-460; DOI: https://doi.org/10.5731/pdajpst.2015.01070

  3. Rathore, Anurag S.

    1. Continuous Processing for Production of Biotech Therapeutics
      Anurag S. Rathore
      PDA Journal of Pharmaceutical Science and Technology May 2015, 69 (3) 333; DOI: https://doi.org/10.5731/pdajpst.2015.01072

  4. Roesti, David

    1. Comparison of Different Calculation Approaches for Defining Microbiological Control Levels Based on Historical Data
      Oliver Gordon, Marcel Goverde, James Pazdan, Alexandra Staerk and David Roesti
      PDA Journal of Pharmaceutical Science and Technology May 2015, 69 (3) 383-398; DOI: https://doi.org/10.5731/pdajpst.2015.01050

  5. Roman, Claudia

    1. Microbial Monitoring For Biological Drug Substance Manufacturing: An Industry Perspective
      David Bain, Diane Hardy, Brian L. Bell, Ren-Yo Forng, Michael Knight, Anita Bawa, Stephanie Ramsey, Christine Arbesser-Rastburg, Mousumi Paul, Christopher Ton, Fran Leira, Claudia Roman, Kim McFarland, David Phillips, Jean Stuckey, Christian Bauer and Andres J. Calvo
      PDA Journal of Pharmaceutical Science and Technology May 2015, 69 (3) 451-460; DOI: https://doi.org/10.5731/pdajpst.2015.01070

  6. Rose, David

    1. Microscopic Characterization of Brevundimonas diminuta in the Hydrated State
      Gary Harp, Seok-Jun Cho, Elisabeth Lester, David Rose, Chandran Sabanyagam and Scott F. Ross
      PDA Journal of Pharmaceutical Science and Technology May 2015, 69 (3) 355-365; DOI: https://doi.org/10.5731/pdajpst.2015.01045

  7. Ross, Scott F.

    1. Microscopic Characterization of Brevundimonas diminuta in the Hydrated State
      Gary Harp, Seok-Jun Cho, Elisabeth Lester, David Rose, Chandran Sabanyagam and Scott F. Ross
      PDA Journal of Pharmaceutical Science and Technology May 2015, 69 (3) 355-365; DOI: https://doi.org/10.5731/pdajpst.2015.01045

  8. Ruppach, Horst

    1. Achieving a Successful Scale-Down Model and Optimized Economics through Parvovirus Filter Validation using Purified TrueSpikeTM Viruses
      Philippe De Vilmorin, Ashley Slocum, Tareq Jaber, Oliver Schaefer, Horst Ruppach and Paul Genest
      PDA Journal of Pharmaceutical Science and Technology May 2015, 69 (3) 440-449; DOI: https://doi.org/10.5731/pdajpst.2015.01054

S

  1. Sabanyagam, Chandran

    1. Microscopic Characterization of Brevundimonas diminuta in the Hydrated State
      Gary Harp, Seok-Jun Cho, Elisabeth Lester, David Rose, Chandran Sabanyagam and Scott F. Ross
      PDA Journal of Pharmaceutical Science and Technology May 2015, 69 (3) 355-365; DOI: https://doi.org/10.5731/pdajpst.2015.01045

  2. Santana, Héctor

    1. Stability Studies of a Freeze-Dried Recombinant Human Epidermal Growth Factor Formulation for Wound Healing
      Héctor Santana, Gerardo García, Maribel Vega, Alejandro Beldarraín and Rolando Páez
      PDA Journal of Pharmaceutical Science and Technology May 2015, 69 (3) 399-416; DOI: https://doi.org/10.5731/pdajpst.2015.01052

  3. Schaefer, Oliver

    1. Achieving a Successful Scale-Down Model and Optimized Economics through Parvovirus Filter Validation using Purified TrueSpikeTM Viruses
      Philippe De Vilmorin, Ashley Slocum, Tareq Jaber, Oliver Schaefer, Horst Ruppach and Paul Genest
      PDA Journal of Pharmaceutical Science and Technology May 2015, 69 (3) 440-449; DOI: https://doi.org/10.5731/pdajpst.2015.01054

  4. Shieu, Wendy

    1. Filling of High-Concentration Monoclonal Antibody Formulations into Pre-filled Syringes: Investigating Formulation-Nozzle Interactions To Minimize Nozzle Clogging
      Wendy Shieu, Oliver B. Stauch and Yuh-Fun Maa
      PDA Journal of Pharmaceutical Science and Technology May 2015, 69 (3) 417-426; DOI: https://doi.org/10.5731/pdajpst.2015.01055

  5. Slocum, Ashley

    1. Achieving a Successful Scale-Down Model and Optimized Economics through Parvovirus Filter Validation using Purified TrueSpikeTM Viruses
      Philippe De Vilmorin, Ashley Slocum, Tareq Jaber, Oliver Schaefer, Horst Ruppach and Paul Genest
      PDA Journal of Pharmaceutical Science and Technology May 2015, 69 (3) 440-449; DOI: https://doi.org/10.5731/pdajpst.2015.01054

  6. Smistad, Gro

    1. Physicochemical Stability of Emulsions and Admixtures for Parenteral Nutrition during Irradiation by Glass-Filtered Daylight at Standardized Conditions
      Marianne Lilletvedt Tovsen, Gro Smistad, Trude Marie Bjerke, Hanne Hjorth Tønnesen and Solveig Kristensen
      PDA Journal of Pharmaceutical Science and Technology May 2015, 69 (3) 346-354; DOI: https://doi.org/10.5731/pdajpst.2015.01036

  7. Staerk, Alexandra

    1. Comparison of Different Calculation Approaches for Defining Microbiological Control Levels Based on Historical Data
      Oliver Gordon, Marcel Goverde, James Pazdan, Alexandra Staerk and David Roesti
      PDA Journal of Pharmaceutical Science and Technology May 2015, 69 (3) 383-398; DOI: https://doi.org/10.5731/pdajpst.2015.01050

  8. Stauch, Oliver B.

    1. Filling of High-Concentration Monoclonal Antibody Formulations into Pre-filled Syringes: Investigating Formulation-Nozzle Interactions To Minimize Nozzle Clogging
      Wendy Shieu, Oliver B. Stauch and Yuh-Fun Maa
      PDA Journal of Pharmaceutical Science and Technology May 2015, 69 (3) 417-426; DOI: https://doi.org/10.5731/pdajpst.2015.01055

  9. Stevenson, Chris

    1. White Paper: Container Closure Integrity Control versus Integrity Testing during Routine Manufacturing
      Scott Ewan, Min Jiang, Chris Stevenson, Olivia Henderson, Steve Klohr, Martha Wessel, Pinky Mehta, Stefanie Adler, Cindy Lake, John Walsh, Tony Polomene and Valja Everaert
      PDA Journal of Pharmaceutical Science and Technology May 2015, 69 (3) 461-465; DOI: https://doi.org/10.5731/pdajpst.2015.01071

  10. Stuckey, Jean

    1. Microbial Monitoring For Biological Drug Substance Manufacturing: An Industry Perspective
      David Bain, Diane Hardy, Brian L. Bell, Ren-Yo Forng, Michael Knight, Anita Bawa, Stephanie Ramsey, Christine Arbesser-Rastburg, Mousumi Paul, Christopher Ton, Fran Leira, Claudia Roman, Kim McFarland, David Phillips, Jean Stuckey, Christian Bauer and Andres J. Calvo
      PDA Journal of Pharmaceutical Science and Technology May 2015, 69 (3) 451-460; DOI: https://doi.org/10.5731/pdajpst.2015.01070

  11. Swanson, Steven

    1. A Means of Establishing and Justifying Binary Ethanol/Water Mixtures as Simulating Solvents in Extractables Studies
      Dennis Jenke, Norman Liu, Yousheng Hua, Steven Swanson and Roy Bogseth
      PDA Journal of Pharmaceutical Science and Technology May 2015, 69 (3) 366-382; DOI: https://doi.org/10.5731/pdajpst.2015.01046

T

  1. Ton, Christopher

    1. Microbial Monitoring For Biological Drug Substance Manufacturing: An Industry Perspective
      David Bain, Diane Hardy, Brian L. Bell, Ren-Yo Forng, Michael Knight, Anita Bawa, Stephanie Ramsey, Christine Arbesser-Rastburg, Mousumi Paul, Christopher Ton, Fran Leira, Claudia Roman, Kim McFarland, David Phillips, Jean Stuckey, Christian Bauer and Andres J. Calvo
      PDA Journal of Pharmaceutical Science and Technology May 2015, 69 (3) 451-460; DOI: https://doi.org/10.5731/pdajpst.2015.01070

  2. Tønnesen, Hanne Hjorth

    1. Physicochemical Stability of Emulsions and Admixtures for Parenteral Nutrition during Irradiation by Glass-Filtered Daylight at Standardized Conditions
      Marianne Lilletvedt Tovsen, Gro Smistad, Trude Marie Bjerke, Hanne Hjorth Tønnesen and Solveig Kristensen
      PDA Journal of Pharmaceutical Science and Technology May 2015, 69 (3) 346-354; DOI: https://doi.org/10.5731/pdajpst.2015.01036

  3. Tovsen, Marianne Lilletvedt

    1. Physicochemical Stability of Emulsions and Admixtures for Parenteral Nutrition during Irradiation by Glass-Filtered Daylight at Standardized Conditions
      Marianne Lilletvedt Tovsen, Gro Smistad, Trude Marie Bjerke, Hanne Hjorth Tønnesen and Solveig Kristensen
      PDA Journal of Pharmaceutical Science and Technology May 2015, 69 (3) 346-354; DOI: https://doi.org/10.5731/pdajpst.2015.01036

V

  1. Vega, Maribel

    1. Stability Studies of a Freeze-Dried Recombinant Human Epidermal Growth Factor Formulation for Wound Healing
      Héctor Santana, Gerardo García, Maribel Vega, Alejandro Beldarraín and Rolando Páez
      PDA Journal of Pharmaceutical Science and Technology May 2015, 69 (3) 399-416; DOI: https://doi.org/10.5731/pdajpst.2015.01052

W

  1. Walsh, John

    1. White Paper: Container Closure Integrity Control versus Integrity Testing during Routine Manufacturing
      Scott Ewan, Min Jiang, Chris Stevenson, Olivia Henderson, Steve Klohr, Martha Wessel, Pinky Mehta, Stefanie Adler, Cindy Lake, John Walsh, Tony Polomene and Valja Everaert
      PDA Journal of Pharmaceutical Science and Technology May 2015, 69 (3) 461-465; DOI: https://doi.org/10.5731/pdajpst.2015.01071

  2. Wessel, Martha

    1. White Paper: Container Closure Integrity Control versus Integrity Testing during Routine Manufacturing
      Scott Ewan, Min Jiang, Chris Stevenson, Olivia Henderson, Steve Klohr, Martha Wessel, Pinky Mehta, Stefanie Adler, Cindy Lake, John Walsh, Tony Polomene and Valja Everaert
      PDA Journal of Pharmaceutical Science and Technology May 2015, 69 (3) 461-465; DOI: https://doi.org/10.5731/pdajpst.2015.01071

  3. Whitman, Darren

    1. Introduction to BioPhorum Operations Group (BPOG) Special Section Editorials
      Darren Whitman
      PDA Journal of Pharmaceutical Science and Technology May 2015, 69 (3) 450; DOI: https://doi.org/10.5731/pdajpst.2015.01069
Back to top

In This Issue