Special Topic Commentaries - Virtual Issue

  • Advancing Cell and Gene Therapeutic Products for Health Impact – Progress on Pharmaceutical Research, Development, Manufacturing and Controls

    Annette Bak, Rodney J.Y. Ho
    Vol. 110, Issue 5, p1869–1870
  • Addressing Patient to Patient Variability for Autologous CAR T Therapies

    Jinlin Jiang, Sanjeev Ahuja
    Vol. 110, Issue 5, p1871–1876
  • Clinical Adoption of Advanced Therapies: Challenges and Opportunities

    Michaela Sharpe, Jacqueline Barry, Panos Kefalas
    Vol. 110, Issue 5, p1877–1884
  • Formulation of Cell-Based Medicinal Products: A Question of Life or Death?

    Karin H. Hoogendoorn, Daan J.A. Crommelin, Wim Jiskoot
    Vol. 110, Issue 5, p1885–1894
  • Translating cell and gene therapies from concept to commercialisation. A commentary on a historical, ongoing journey

    Matthew Cobb
    Vol. 110, Issue 5, p1895–1899
  • Strategies for Implementing New Drying & Packaging Technology for Sterile Injectable Drug Products

    Jim Searles, Satoshi Ohtake
    Vol. 110, Issue 5, p1931–1934
  • Addressing the Cold Reality of mRNA Vaccine Stability

    Daan J.A. Crommelin, Thomas J. Anchordoquy, David B. Volkin, Wim Jiskoot, Enrico Mastrobattista
    Vol. 110, Issue 3, p997–1001
    Open Access
  • Editorial

    Kenneth L. Audus
    Vol. 110, Issue 2, p554
  • In Vitro Biopredictive Methods: A Workshop Summary Report

    Xavier J.H. Pepin, Jennifer Dressman, Neil Parrott, Poonam Delvadia, Amitava Mitra, Xinyuan Zhang, Andrew Babiskin, Vidula Kolhatkar, Paul Seo, Lynne S. Taylor, Erik Sjögren, James M. Butler, Edmund Kostewicz, Christer Tannergren, Mirko Koziolek, Filippos Kesisoglou, André Dallmann, Yang Zhao, Sandra Suarez-Sharp
    Vol. 110, Issue 2, p567–583
  • Current State and Future Expectations of Translational Modeling Strategies to Support Drug Product Development, Manufacturing Changes and Controls: A Workshop Summary Report

    Xavier J.H. Pepin, Neil Parrott, Jennifer Dressman, Poonam Delvadia, Amitava Mitra, Xinyuan Zhang, Andrew Babiskin, Vidula Kolhatkar, Sandra Suarez-Sharp
    Vol. 110, Issue 2, p555–566
  • Best Practices in the Development and Validation of Physiologically Based Biopharmaceutics Modeling. A Workshop Summary Report

    Neil Parrott, Sandra Suarez-Sharp, Filippos Kesisoglou, Shriram M. Pathak, David Good, Christian Wagner, André Dallmann, James Mullin, Nikunjkumar Patel, Arian Emami Riedmaier, Amitava Mitra, Kimberly Raines, James Butler, Maziar Kakhi, Min Li, Yang Zhao, Eleftheria Tsakalozou, Talia Flanagan, Jennifer Dressman, Xavier Pepin
    Vol. 110, Issue 2, p584–593
  • Applications of Physiologically Based Biopharmaceutics Modeling (PBBM) to Support Drug Product Quality: A Workshop Summary Report

    Amitava Mitra, Sandra Suarez-Sharp, Xavier J.H. Pepin, Talia Flanagan, Yang Zhao, Evangelos Kotzagiorgis, Neil Parrott, Satish Sharan, Christophe Tistaert, Tycho Heimbach, Banu Zolnik, Erik Sjögren, Fang Wu, Om Anand, Shefali Kakar, Min Li, Shereeni Veerasingham, Shinichi Kijima, Gustavo Mendes Lima Santos, Baoming Ning, Kimberly Raines, Greg Rullo, Haritha Mandula, Poonam Delvadia, Jennifer Dressman, Paul A. Dickinson, Andrew Babiskin
    Vol. 110, Issue 2, p594–609
  • Scientific Best Practices for Primary Sequence Confirmation and Sequence Variant Analysis in the Development of Therapeutic Proteins

    Anders Lund, Da Ren, Richard S. Rogers, Jason C. Rouse, X. Christopher Yu, John F. Valliere-Douglass
    Vol. 110, Issue 2, p619–626
  • The Science is There: Key Considerations for Stabilizing Viral Vector-Based Covid-19 Vaccines

    Daan J.A. Crommelin, David B. Volkin, Karin H. Hoogendoorn, Anthony S. Lubiniecki, Wim Jiskoot
    Vol. 110, Issue 2, p627–634
  • Per Artursson’s Major Contributions to the Caco-2 Cell Literature in Pharmaceutical Sciences

    David J. Brayden
    Vol. 110, Issue 1, p12–16
  • Dilemmas With Absolute Quantification of Pharmacologically Relevant Proteins Using Mass Spectrometry

    Jacek R. Wiśniewski
    Vol. 110, Issue 1, p17–21
  • Synergistic Computational Modeling Approaches as Team Players in the Game of Solubility Predictions

    Martin Kuentz, Christel A.S. Bergström
    Vol. 110, Issue 1, p22–34
  • Challenges of Using Closed System Transfer Devices With Biological Drug Products: An Industry Perspective

    Alavattam Sreedhara, Camellia Zamiri, Sumit Goswami, Sarah Weiser, Michael Cram, Twinkle R. Christian, Bharat Jagannathan
    Vol. 109, Issue 1, p22–29
  • Shifting Paradigms Revisited: Biotechnology and the Pharmaceutical Sciences

    Daan J.A. Crommelin, Enrico Mastrobattista, Andrea Hawe, Karin H. Hoogendoorn, Wim Jiskoot
    Vol. 109, Issue 1, p30–43
  • Translating Cell and Gene Biopharmaceutical Products for Health and Market Impact. Product Scaling From Clinical to Marketplace: Lessons Learned and Future Outlook

    Annette Bak, Kristina Pagh Friis, Yan Wu, Rodney J.Y. Ho
    Vol. 108, Issue 10, p3169–3175
  • Physiologically Based Pharmacokinetic Modeling in Regulatory Science: An Update From the U.S. Food and Drug Administration’s Office of Clinical Pharmacology

    Manuela Grimstein, Yuching Yang, Xinyuan Zhang, Joseph Grillo, Shiew-Mei Huang, Issam Zineh, Yaning Wang
    Vol. 108, Issue 1, p21–25
  • Roadmap to 3D-Printed Oral Pharmaceutical Dosage Forms: Feedstock Filament Properties and Characterization for Fused Deposition Modeling

    Johanna Aho, Johan Peter Bøtker, Natalja Genina, Magnus Edinger, Lærke Arnfast, Jukka Rantanen
    Vol. 108, Issue 1, p26–35
  • FIP Guidelines for Dissolution Testing of Solid Oral Products

    Horst Dieter Friedel, Cynthia K. Brown, Amy R. Barker, Lucinda F. Buhse, Susanne Keitel, Johannes Kraemer, John Michael Morris, Christos Reppas, David C. Sperry, Kumiko Sakai-Kato, Mary P. Stickelmeyer, Vinod P. Shah
    Vol. 107, Issue 12, p2995–3002
  • Density and Shape Factor Terms in Stokes' Equation for Aerodynamic Behavior of Aerosols

    Anthony J. Hickey, David A. Edwards
    Vol. 107, Issue 3, p794–796
  • Recent Topics of Research in the Characterization and Quality Control of Biopharmaceuticals in Japan

    Akiko Ishii-Watabe, Hiroko Shibata, Akira Harazono, Masashi Hyuga, Masato Kiyoshi, Satoshi Saitoh, Takafumi Iwura, Tetsuo Torisu, Yukihiro Goda, Susumu Uchiyama
    Vol. 106, Issue 12, p3431–3437
    Open Access
  • Mixed Reality Meets Pharmaceutical Development

    William P. Forrest, Megan A. Mackey, Vivek M. Shah, Kerry M. Hassell, Prashant Shah, Jennifer L. Wylie, Janakiraman Gopinath, Henning Balderhaar, Li Li, W. Peter Wuelfing, Roy Helmy
    Vol. 106, Issue 12, p3438–3441
  • Regulatory Perspectives on Continuous Pharmaceutical Manufacturing: Moving From Theory to Practice: September 26-27, 2016, International Symposium on the Continuous Manufacturing of Pharmaceuticals

    Moheb M. Nasr, Markus Krumme, Yoshihiro Matsuda, Bernhardt L. Trout, Clive Badman, Salvatore Mascia, Charles L. Cooney, Keith D. Jensen, Alastair Florence, Craig Johnston, Konstantin Konstantinov, Sau L. Lee
    Vol. 106, Issue 11, p3199–3206
  • Is Ethnic Variability in the Exposure to Rosuvastatin Explained Only by Genetic Polymorphisms in OATP1B1 and BCRP or Should the Contribution of Intrinsic Ethnic Differences in OATP1B1 Be Considered?

    Yuichi Sugiyama, Kazuya Maeda, Kota Toshimoto
    Vol. 106, Issue 9, p2227–2230
  • Understanding the Potential Interethnic Difference in Rosuvastatin Pharmacokinetics

    Leslie Z. Benet, Hsin-Fang Wu
    Vol. 106, Issue 9, p2231–2233
  • Lyophilized Drug Product Cake Appearance: What Is Acceptable?

    Sajal Manubhai Patel, Steven L. Nail, Michael J. Pikal, Raimund Geidobler, Gerhard Winter, Andrea Hawe, Juan Davagnino, Shailaja Rambhatla Gupta
    Vol. 106, Issue 7, p1706–1721
  • An Opportunity for Industry–Academia Partnership: Training the Next Generation of Industrial Researchers in Characterizing Higher Order Protein Structure

    David L. Bain, Michael Brenowitz, Christopher J. Roberts
    Vol. 105, Issue 12, p3483–3486
  • Technical Decision Making with Higher Order Structure Data: Utilization of Differential Scanning Calorimetry to Elucidate Critical Protein Structural Changes Resulting from Oxidation

    Kelly K. Arthur, Nikita Dinh, John P. Gabrielson
    Vol. 104, Issue 4, p1548–1554
  • Technical Decision-Making with Higher Order Structure Data: Specific Binding of a Nonionic Detergent Perturbs Higher Order Structure of a Therapeutic Monoclonal Antibody

    Ivan L. Budyak, Brandon L. Doyle, William F. Weiss IV
    Vol. 104, Issue 4, p1543–1547
  • Technical Decision Making with Higher Order Structure Data: Impact of a Formulation Change on the Higher Order Structure and Stability of a mAb

    Flaviu Gruia, Jiali Du, Paul V. Santacroce, Richard L. Remmele Jr, Jared S. Bee
    Vol. 104, Issue 4, p1539–1542
  • Technical Decision Making with Higher Order Structure Data: Higher Order Structure Characterization During Protein Therapeutic Candidate Screening

    Yijia Jiang, Cynthia Li, Jenny Li, John P. Gabrielson, Jie Wen
    Vol. 104, Issue 4, p1533–1538
  • Technical Decision-Making with Higher Order Structure Data: Starting a New Dialogue

    John P. Gabrielson, William F. Weiss IV
    Vol. 104, Issue 4, p1240–1245
  • Editorial

    John F. Carpenter
    Vol. 104, Issue 3, p778
  • Achieving Continuous Manufacturing May 20–21 2014 Continuous Manufacturing Symposium

    Clive Badman, Bernhardt L. Trout
    Vol. 104, Issue 3, p779–780
  • Achieving Continuous Manufacturing: Technologies and Approaches for Synthesis, Workup, and Isolation of Drug Substance May 20–21, 2014 Continuous Manufacturing Symposium

    Ian R. Baxendale, Richard D. Braatz, Benjamin K. Hodnett, Klavs F. Jensen, Martin D. Johnson, Paul Sharratt, Jon-Paul Sherlock, Alastair J. Florence
    Vol. 104, Issue 3, p781–791
  • Achieving Continuous Manufacturing for Final Dosage Formation: Challenges and How to Meet Them May 20–21 2014 Continuous Manufacturing Symposium

    Stephen Byrn, Maricio Futran, Hayden Thomas, Eric Jayjock, Nicola Maron, Robert F. Meyer, Allan S. Myerson, Michael P. Thien, Bernhardt L. Trout
    Vol. 104, Issue 3, p792–802
  • Regulatory and Quality Considerations for Continuous Manufacturing May 20–21, 2014 Continuous Manufacturing Symposium

    Gretchen Allison, Yanxi Tan Cain, Charles Cooney, Tom Garcia, Tara Gooen Bizjak, Oyvind Holte, Nirdosh Jagota, Bekki Komas, Evdokia Korakianiti, Dora Kourti, Rapti Madurawe, Elaine Morefield, Frank Montgomery, Moheb Nasr, William Randolph, Jean-Louis Robert, Dave Rudd, Diane Zezza
    Vol. 104, Issue 3, p803–812
  • White Paper on Continuous Bioprocessing May 20–21 2014 Continuous Manufacturing Symposium

    Konstantin B. Konstantinov, Charles L. Cooney
    Vol. 104, Issue 3, p813–820
  • Equipment and Analytical Companies Meeting Continuous Challenges May 20–21 2014 Continuous Manufacturing Symposium

    Trevor Page, Henry Dubina, Gabriele Fillipi, Roland Guidat, Saroj Patnaik, Peter Poechlauer, Phil Shering, Martin Guinn, Peter Mcdonnell, Craig Johnston
    Vol. 104, Issue 3, p821–831
  • Control Systems Engineering in Continuous Pharmaceutical Manufacturing May 20–21, 2014 Continuous Manufacturing Symposium

    Allan S. Myerson, Markus Krumme, Moheb Nasr, Hayden Thomas, Richard D. Braatz
    Vol. 104, Issue 3, p832–839
  • Future Supply Chains Enabled by Continuous Processing—Opportunities Challenges May 20–21 2014 Continuous Manufacturing Symposium

    Jagjit Singh Srai, Clive Badman, Markus Krumme, Mauricio Futran, Craig Johnston
    Vol. 104, Issue 3, p840–849
    Open Access
  • How Development and Manufacturing Will Need to Be Structured—Heads of Development/Manufacturing May 20–21, 2014 Continuous Manufacturing Symposium

    Kevin Nepveux, Jon-Paul Sherlock, Mauricio Futran, Michael Thien, Markus Krumme
    Vol. 104, Issue 3, p850–864