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There are 37537 results for: content related to: Current Perspectives on Stability of Protein Drug Products during Formulation, Fill and Finish Operations

  1. Effective Encapsulation of Proteins into Size-Controlled Phospholipid Vesicles Using Freeze-Thawing and Extrusion

    Biotechnology Progress

    Volume 19, Issue 5, 2003, Pages: 1547–1552, Keitaro Sou, Yoshiyasu Naito, Taro Endo, Shinji Takeoka and Eishun Tsuchida

    Version of Record online : 5 SEP 2008, DOI: 10.1021/bp0201004

  2. Banking of clinical samples for proteomic biomarker studies: A consideration of logistical issues with a focus on pre-analytical variation

    PROTEOMICS - Clinical Applications

    Volume 4, Issue 3, March 2010, Pages: 250–270, David H. Jackson and Rosamonde E. Banks

    Version of Record online : 7 JAN 2010, DOI: 10.1002/prca.200900220

  3. You have free access to this content
    Appendix V: 21 Code of U.S. Federal Regulations Parts 210 and 211 Current Good Manufacturing Practice Regulations

    Establishing a CGMP Laboratory Audit System: A Practical Guide

    David M. Bliesner, Pages: 236–267, 2006

    Published Online : 5 APR 2006, DOI: 10.1002/0471784788.app5

  4. Stability of lipid/DNA complexes during agitation and freeze–thawing

    Journal of Pharmaceutical Sciences

    Volume 87, Issue 9, September 1998, Pages: 1046–1051, Thomas J. Anchordoquy, Lorinda G. Girouard, John F. Carpenter and David J. Kroll

    Version of Record online : 12 JUN 2000, DOI: 10.1021/js9801891

  5. Product quality for nanomaterials: current U.S. experience and perspective

    Wiley Interdisciplinary Reviews: Nanomedicine and Nanobiotechnology

    Volume 7, Issue 5, September/October 2015, Pages: 640–654, Katherine M. Tyner, Peng Zou, Xiaochuan Yang, Hailing Zhang, Celia N. Cruz and Sau L. Lee

    Version of Record online : 30 JAN 2015, DOI: 10.1002/wnan.1338

  6. Good Manufacturing Practices (GMP) and Related FDA Guidelines

    Standard Article

    Pharmaceutical Sciences Encyclopedia

    James R. Harris

    Published Online : 15 MAR 2010, DOI: 10.1002/9780470571224.pse374

  7. Impact of Manufacturing Processes on Drug Product Stability and Quality

    Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals

    Nitin Rathore, Rahul S. Rajan, Erwin Freund, Pages: 917–940, 2010

    Published Online : 5 AUG 2010, DOI: 10.1002/9780470595886.ch37

  8. Effects of tween 80 and sucrose on acute short-term stability and long-term storage at −20 °C of a recombinant hemoglobin

    Journal of Pharmaceutical Sciences

    Volume 87, Issue 9, September 1998, Pages: 1062–1068, Bruce A. Kerwin, Martin C. Heller, Steven H. Levin and Theodore W. Randolph

    Version of Record online : 12 JUN 2000, DOI: 10.1021/js980140v

  9. Good Manufacturing Practices (GMP) and Related FDA Guidelines

    Pharmaceutical Manufacturing Handbook: Regulations and Quality

    Shayne Cox Gad, Pages: 1–43, 2007

    Published Online : 28 AUG 2007, DOI: 10.1002/9780470259832.ch1

  10. Stability of Serum-Free and Purified Baculovirus Stocks under Various Storage Conditions

    Biotechnology Progress

    Volume 22, Issue 1, 2006, Pages: 319–325, Hasnaa Jorio, Rosa Tran and Amine Kamen

    Version of Record online : 16 SEP 2008, DOI: 10.1021/bp050218v

  11. The assessment of impurities for genotoxic potential and subsequent control in drug substance and drug product

    Journal of Pharmaceutical Sciences

    Volume 102, Issue 5, May 2013, Pages: 1404–1418, Linda K. Dow, Marvin M. Hansen, Brian W. Pack, Todd J. Page and Steven W. Baertschi

    Version of Record online : 21 FEB 2013, DOI: 10.1002/jps.23462

  12. Effect of Packaging on Stability of Drugs and Drug Products

    Pharmaceutical Manufacturing Handbook: Regulations and Quality

    Shayne Cox Gad, Pages: 641–686, 2007

    Published Online : 28 AUG 2007, DOI: 10.1002/9780470259832.ch19

  13. Stability and Shelf Life of Pharmaceutical Products

    Standard Article

    Pharmaceutical Sciences Encyclopedia

    Ranga Velagaleti

    Published Online : 15 MAR 2010, DOI: 10.1002/9780470571224.pse390

  14. On developing a process for conducting extractable–leachable assessment of components used for storage of biopharmaceuticals

    Journal of Pharmaceutical Sciences

    Volume 99, Issue 5, May 2010, Pages: 2209–2218, Aditya A. Wakankar, Y. John Wang, Eleanor Canova-Davis, Stacey Ma, Dieter Schmalzing, Josh Grieco, Terry Milby, Theresa Reynolds, Kellen Mazzarella, Ed Hoff, Stephen Gomez and Sherry Martin-Moe

    Version of Record online : 28 DEC 2009, DOI: 10.1002/jps.22012

  15. Stability and Shelf Life of Pharmaceutical Products

    Pharmaceutical Manufacturing Handbook: Regulations and Quality

    Shayne Cox Gad, Pages: 557–582, 2007

    Published Online : 28 AUG 2007, DOI: 10.1002/9780470259832.ch17

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    Integration of active pharmaceutical ingredient solid form selection and particle engineering into drug product design

    Journal of Pharmacy and Pharmacology

    Volume 67, Issue 6, June 2015, Pages: 782–802, Martyn David Ticehurst and Ivan Marziano

    Version of Record online : 10 FEB 2015, DOI: 10.1111/jphp.12375

  17. Mechanisms of Inactivation of HSV-2 during Storage in Frozen and Lyophilized Forms

    Biotechnology Progress

    Volume 21, Issue 3, 2005, Pages: 911–917, Raino K. Hansen, Suling Zhai, Jeremy N. Skepper, Mike D. Johnston, H. Oya Alpar and Nigel K. H. Slater

    Version of Record online : 5 SEP 2008, DOI: 10.1021/bp049601a

  18. The Biopharmaceutics Risk Assessment Roadmap for Optimizing Clinical Drug Product Performance

    Journal of Pharmaceutical Sciences

    Volume 103, Issue 11, November 2014, Pages: 3377–3397, Arzu Selen, Paul A. Dickinson, Anette Müllertz, John R. Crison, Hitesh B. Mistry, Maria T. Cruañes, Marilyn N. Martinez, Hans Lennernäs, Tim L. Wigal, David C. Swinney, James E. Polli, Abu T. M. Serajuddin, Jack A. Cook and Jennifer B. Dressman

    Version of Record online : 24 SEP 2014, DOI: 10.1002/jps.24162

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    A new roadmap for biopharmaceutical drug product development: Integrating development, validation, and quality by design

    Journal of Pharmaceutical Sciences

    Volume 100, Issue 8, August 2011, Pages: 3031–3043, Sheryl Martin-Moe, Fredric J. Lim, Rita L. Wong, Alavattam Sreedhara, Jagannathan Sundaram and Samir U. Sane

    Version of Record online : 18 MAR 2011, DOI: 10.1002/jps.22545

  20. Analytical Leachables Studies

    Leachables and Extractables Handbook: Safety Evaluation, Qualification, and Best Practices Applied to Inhalation Drug Products

    Andrew D. Feilden, Andy Rignall, Pages: 417–447, 2012

    Published Online : 28 FEB 2012, DOI: 10.1002/9781118147672.ch17