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There are 41338 results for: content related to: Particles in therapeutic protein formulations, Part 1: Overview of analytical methods

  1. Subvisible (2–100 μm) Particle Analysis During Biotherapeutic Drug Product Development: Part 1, Considerations and Strategy

    Journal of Pharmaceutical Sciences

    Volume 104, Issue 6, June 2015, Pages: 1899–1908, Linda O. Narhi, Vincent Corvari, Dean C. Ripple, Nataliya Afonina, Irene Cecchini, Michael R. Defelippis, Patrick Garidel, Andrea Herre, Atanas V. Koulov, Tony Lubiniecki, Hanns-Christian Mahler, Paolo Mangiagalli, Douglas Nesta, Bernardo Perez-Ramirez, Alla Polozova, Mara Rossi, Roland Schmidt, Robert Simler, Satish Singh, Thomas M. Spitznagel, Andrew Weiskopf and Klaus Wuchner

    Version of Record online : 1 APR 2015, DOI: 10.1002/jps.24437

  2. Analytical Methods to Measure Subvisible Particulates

    Analysis of Aggregates and Particles in Protein Pharmaceuticals

    Shawn Cao, Linda Narhi, Yijia Jiang, Rahul S. Rajan, Pages: 85–115, 2012

    Published Online : 13 JAN 2012, DOI: 10.1002/9781118150573.ch5

  3. You have free access to this content
    Calculating the Mass of Subvisible Protein Particles with Improved Accuracy Using Microflow Imaging Data

    Journal of Pharmaceutical Sciences

    Volume 104, Issue 2, February 2015, Pages: 536–547, Cavan Kalonia, Ozan S. Kumru, Indira Prajapati, Roman Mathaes, Julia Engert, Shuxia Zhou, C. Russell Middaugh and David B. Volkin

    Version of Record online : 9 OCT 2014, DOI: 10.1002/jps.24156

  4. Label-Free Flow Cytometry Analysis of Subvisible Aggregates in Liquid IgG1 Antibody Formulations

    Journal of Pharmaceutical Sciences

    Volume 103, Issue 1, January 2014, Pages: 90–99, Hirotaka Nishi, Roman Mathäs, Robert Fürst and Gerhard Winter

    Version of Record online : 11 NOV 2013, DOI: 10.1002/jps.23782

  5. Development of a microflow digital imaging assay to characterize protein particulates during storage of a high concentration IgG1 monoclonal antibody formulation

    Journal of Pharmaceutical Sciences

    Volume 99, Issue 8, August 2010, Pages: 3343–3361, Klaus Wuchner, Jochen Büchler, Rene Spycher, Paul Dalmonte and David B. Volkin

    Version of Record online : 12 MAR 2010, DOI: 10.1002/jps.22123

  6. An industry perspective on the monitoring of subvisible particles as a quality attribute for protein therapeutics

    Journal of Pharmaceutical Sciences

    Volume 99, Issue 8, August 2010, Pages: 3302–3321, Satish K. Singh, Nataliya Afonina, Michel Awwad, Karoline Bechtold-Peters, Jeffrey T. Blue, Danny Chou, Mary Cromwell, Hans-Juergen Krause, Hanns-Christian Mahler, Brian K. Meyer, Linda Narhi, Doug P. Nesta and Thomas Spitznagel

    Version of Record online : 22 MAR 2010, DOI: 10.1002/jps.22097

  7. Characterization of subvisible particle formation during the filling pump operation of a monoclonal antibody solution

    Journal of Pharmaceutical Sciences

    Volume 100, Issue 10, October 2011, Pages: 4198–4204, Arpan Nayak, James Colandene, Victor Bradford and Melissa Perkins

    Version of Record online : 22 JUN 2011, DOI: 10.1002/jps.22676

  8. Radar Chart Array Analysis to Visualize Effects of Formulation Variables on IgG1 Particle Formation as Measured by Multiple Analytical Techniques

    Journal of Pharmaceutical Sciences

    Volume 102, Issue 12, December 2013, Pages: 4256–4267, Cavan Kalonia, Ozan S. Kumru, Jae Hyun Kim, C. Russell Middaugh and David B. Volkin

    Version of Record online : 9 OCT 2013, DOI: 10.1002/jps.23738

  9. Compatibility, physical stability, and characterization of an IgG4 monoclonal antibody after dilution into different intravenous administration bags

    Journal of Pharmaceutical Sciences

    Volume 101, Issue 10, October 2012, Pages: 3636–3650, Ozan S. Kumru, Jun Liu, Junyan A. Ji, Wilson Cheng, Y. John Wang, Tingting Wang, Sangeeta B. Joshi, C. Russell Middaugh and David B. Volkin

    Version of Record online : 25 JUN 2012, DOI: 10.1002/jps.23224

  10. Unmasking Translucent Protein Particles by Improved Micro-Flow Imaging™ Algorithms

    Journal of Pharmaceutical Sciences

    Volume 103, Issue 1, January 2014, Pages: 107–114, Jesper Søndergaard Pedersen and Malin Persson

    Version of Record online : 26 NOV 2013, DOI: 10.1002/jps.23786

  11. Protein particles: What we know and what we do not know

    Journal of Pharmaceutical Sciences

    Volume 101, Issue 10, October 2012, Pages: 3568–3579, Dean C. Ripple and Mariana N. Dimitrova

    Version of Record online : 26 JUN 2012, DOI: 10.1002/jps.23242

  12. Structural Characterization of IgG1 mAb Aggregates and Particles Generated Under Various Stress Conditions

    Journal of Pharmaceutical Sciences

    Volume 103, Issue 3, March 2014, Pages: 796–809, Srivalli N. Telikepalli, Ozan S. Kumru, Cavan Kalonia, Reza Esfandiary, Sangeeta B. Joshi, C. Russell Middaugh and David B. Volkin

    Version of Record online : 22 JAN 2014, DOI: 10.1002/jps.23839

  13. How subvisible particles become invisible—relevance of the refractive index for protein particle analysis

    Journal of Pharmaceutical Sciences

    Volume 102, Issue 5, May 2013, Pages: 1434–1446, Sarah Zölls, Manuel Gregoritza, Ruedeeporn Tantipolphan, Michael Wiggenhorn, Gerhard Winter, Wolfgang Friess and Andrea Hawe

    Version of Record online : 5 MAR 2013, DOI: 10.1002/jps.23479

  14. Mechanistic complexity of subvisible particle formation: Links to protein aggregation are highly specific

    Journal of Pharmaceutical Sciences

    Volume 101, Issue 11, November 2012, Pages: 4140–4154, B. Robert Simler, Guodong Hui, Jennifer E. Dahl and Bernardo Perez-Ramirez

    Version of Record online : 21 AUG 2012, DOI: 10.1002/jps.23299

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    Index

    Analysis of Aggregates and Particles in Protein Pharmaceuticals

    Hanns-Christian Mahler, Wim Jiskoot, Pages: 389–443, 2012

    Published Online : 13 JAN 2012, DOI: 10.1002/9781118150573.index

  16. Physical Characterization and In Vitro Biological Impact of Highly Aggregated Antibodies Separated into Size-Enriched Populations by Fluorescence-Activated Cell Sorting

    Journal of Pharmaceutical Sciences

    Volume 104, Issue 5, May 2015, Pages: 1575–1591, Srivalli Telikepalli, Heather E. Shinogle, Prem S. Thapa, Jae Hyun Kim, Meghana Deshpande, Vibha Jawa, C. Russell Middaugh, Linda O. Narhi, Marisa K. Joubert and David B. Volkin

    Version of Record online : 5 MAR 2015, DOI: 10.1002/jps.24379

  17. Experimental Detection and Characterization of Protein Aggregates

    Aggregation of Therapeutic Proteins

    Vikas K. Sharma, Devendra S. Kalonia, Pages: 205–256, 2010

    Published Online : 5 AUG 2010, DOI: 10.1002/9780470769829.ch5

  18. Characterization of Submicron (0.1–1 μm) Particles in Therapeutic Proteins by Nanoparticle Tracking Analysis

    Journal of Pharmaceutical Sciences

    Volume 104, Issue 5, May 2015, Pages: 1622–1631, Rekha Vasudev, Sam Mathew and Nataliya Afonina

    Version of Record online : 3 MAR 2015, DOI: 10.1002/jps.24411

  19. Quantification and characterization of subvisible proteinaceous particles in opalescent mAb Formulations Using Micro-Flow Imaging

    Journal of Pharmaceutical Sciences

    Volume 99, Issue 6, June 2010, Pages: 2628–2642, Deepak K. Sharma, Peter Oma, Mark J. Pollo and Muppalla Sukumar

    Version of Record online : 4 JAN 2010, DOI: 10.1002/jps.22046

  20. Detection of Visible Particles in Parenteral Products

    Analysis of Aggregates and Particles in Protein Pharmaceuticals

    Ronald Smulders, Hans Vos, Hanns-Christian Mahler, Pages: 117–132, 2012

    Published Online : 13 JAN 2012, DOI: 10.1002/9781118150573.ch6