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Research Article

Effect of Product Temperature During Primary Drying on the Long-Term Stability of Lyophilized Proteins

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Pages 543-553 | Received 27 Mar 2007, Accepted 15 Jun 2007, Published online: 07 Oct 2008

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Read on this site (7)

Zulfiqar A. Vohra, Sandeep S. Zode & Arvind K. Bansal. (2019) Effect of primary drying temperature on process efficiency and product performance of lyophilized Ertapenam sodium. Drug Development and Industrial Pharmacy 45:12, pages 1940-1948.
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Divisha Jain, S. Shahe Mahammad, Pirthi Pal Singh & Ravinder Kodipyaka. (2019) A review on parenteral delivery of peptides and proteins. Drug Development and Industrial Pharmacy 45:9, pages 1403-1420.
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Bianca Sylvester, Alina Porfire, Marcela Achim, Lucia Rus & Ioan Tomuţă. (2018) A step forward towards the development of stable freeze-dried liposomes: a quality by design approach (QbD). Drug Development and Industrial Pharmacy 44:3, pages 385-397.
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Stefan C. Schneid, Peter M. Stärtzel, Patrick Lettner & Henning Gieseler. (2011) Robustness testing in pharmaceutical freeze-drying: Inter-relation of process conditions and product quality attributes studied for a vaccine formulation. Pharmaceutical Development and Technology 16:6, pages 583-590.
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Mathias Aschenbrenner, Ulrich Kulozik & Petra Foerst. (2011) In Situ Determination of the Physical State of Biological Samples during Freeze Drying. Drying Technology 29:4, pages 461-471.
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Articles from other publishers (37)

Isabel Kalinke & Ulrich Kulozik. (2023) Irreversible thermochromic ink in the identification of over- and under-processed product segments in microwave-assisted freeze drying. Journal of Food Engineering 349, pages 111470.
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Nayra Oliveira Prado, Larissa Araújo Lalli, Lucas Blanes, Dalila Lucíola Zanette & Mateus Nóbrega Aoki. (2023) Lyophilization of Molecular Biology Reactions: A Review. Mini-Reviews in Medicinal Chemistry 23:4, pages 480-496.
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Daniel Kullmann, Carmen Lema Martinez, Jörg Lümkemann & Jörg Huwyler. (2023) Part I: Significant reduction of lyophilization process times by using novel matrix based scaffolds. European Journal of Pharmaceutics and Biopharmaceutics 184, pages 248-261.
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Kyu Yoon & Vivek Narsimhan. 2023. Principles and Practices of Lyophilization in Product Development and Manufacturing. Principles and Practices of Lyophilization in Product Development and Manufacturing 219 242 .
Ciarán Ó’Fágáin & Keith Colliton. 2023. Protein Chromatography. Protein Chromatography 421 475 .
Sebastian Gruber, Maximilian Thomik, Nicole Vorhauer-Huget, Lukas Hans, Evangelos Tsotsas & Petra Foerst. (2022) The Influence of Local Microstructure Inhomogeneities on Local Drying Kinetics during Freeze-Drying. Pharmaceutics 14:10, pages 2132.
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Tim Wenzel, Margit Gieseler, Ahmad M. Abdul-Fattah & Henning Gieseler. (2021) Cycle Development in a Mini-Freeze Dryer: Evaluation of Manometric Temperature Measurement in Small-Scale Equipment. AAPS PharmSciTech 22:4.
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Arun Butreddy, Narendar Dudhipala, Karthik Yadav Janga & Rajendra Prasad Gaddam. (2020) Lyophilization of Small-Molecule Injectables: an Industry Perspective on Formulation Development, Process Optimization, Scale-Up Challenges, and Drug Product Quality Attributes. AAPS PharmSciTech 21:7.
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Nirajan Adhikari, Tong Zhu, Feroz Jameel, Ted Tharp, Sherwin Shang & Alina Alexeenko. (2020) Sensitivity Study to Assess the Robustness of Primary Drying Process in Pharmaceutical Lyophilization. Journal of Pharmaceutical Sciences 109:2, pages 1043-1049.
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Christina Haeuser, Pierre Goldbach, Joerg Huwyler, Wolfgang Friess & Andrea Allmendinger. (2019) Be Aggressive! Amorphous Excipients Enabling Single-Step Freeze-Drying of Monoclonal Antibody Formulations. Pharmaceutics 11:11, pages 616.
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Swapnil K. Pansare & Sajal M. Patel. (2019) Lyophilization Process Design and Development: A Single-Step Drying Approach. Journal of Pharmaceutical Sciences 108:4, pages 1423-1433.
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Erwan Bourlès, Gael de Lannoy, Bernadette Scutellà, Fernanda Fonseca, Ioan Cristian Trelea & Stephanie Passot. 2019. Lyophilization of Pharmaceuticals and Biologicals. Lyophilization of Pharmaceuticals and Biologicals 215 240 .
Maja Bjelošević, Katarina Bolko Seljak, Uroš Trstenjak, Manca Logar, Boris Brus & Pegi Ahlin Grabnar. (2018) Aggressive conditions during primary drying as a contemporary approach to optimise freeze-drying cycles of biopharmaceuticals. European Journal of Pharmaceutical Sciences 122, pages 292-302.
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Ryo Ohori, Tomomi Akita & Chikamasa Yamashita. (2018) Effect of temperature ramp rate during the primary drying process on the properties of amorphous-based lyophilized cake, Part 2: Successful lyophilization by adopting a fast ramp rate during primary drying in protein formulations. European Journal of Pharmaceutics and Biopharmaceutics 130, pages 83-95.
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Jacqueline Horn, Julia Schanda & Wolfgang Friess. (2018) Impact of fast and conservative freeze-drying on product quality of protein-mannitol-sucrose-glycerol lyophilizates. European Journal of Pharmaceutics and Biopharmaceutics 127, pages 342-354.
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Jacqueline Horn & Wolfgang Friess. (2018) Detection of Collapse and Crystallization of Saccharide, Protein, and Mannitol Formulations by Optical Fibers in Lyophilization. Frontiers in Chemistry 6.
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Maxwell Korang-Yeboah, Charudharshini Srinivasan, Akhtar Siddiqui, David Awotwe-Otoo, Celia N. Cruz & Ashraf Muhammad. (2017) Application of Optical Coherence Tomography Freeze-Drying Microscopy for Designing Lyophilization Process and Its Impact on Process Efficiency and Product Quality. AAPS PharmSciTech 19:1, pages 448-459.
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Bianca Sylvester, Alina Porfire, Pieter-Jan Van Bockstal, Sebastian Porav, Marcela Achim, Thomas De Beer & Ioan Tomuţă. (2018) Formulation Optimization of Freeze-Dried Long-Circulating Liposomes and In-Line Monitoring of the Freeze-Drying Process Using an NIR Spectroscopy Tool. Journal of Pharmaceutical Sciences 107:1, pages 139-148.
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B. Scutellà, A. Plana-Fattori, S. Passot, E. Bourlès, F. Fonseca, D. Flick & I.C. Tréléa. (2017) 3D mathematical modelling to understand atypical heat transfer observed in vial freeze-drying. Applied Thermal Engineering 126, pages 226-236.
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Sylvain DevilleSylvain Deville. 2017. Freezing Colloids: Observations, Principles, Control, and Use. Freezing Colloids: Observations, Principles, Control, and Use 351 438 .
Adva Mechaly, Sharon Marx, Orly Levy, Shmuel Yitzhaki & Morly Fisher. (2016) Highly Stable Lyophilized Homogeneous Bead-Based Immunoassays for On-Site Detection of Bio Warfare Agents from Complex Matrices. Analytical Chemistry 88:12, pages 6283-6291.
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Marcin Czyż, Radosław Dembczyński, Roman Marecik & Tomasz Pniewski. (2016) Stability of S-HBsAg in long-term stored lyophilised plant tissue. Biologicals 44:2, pages 69-72.
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Drew Clearfield & Mei Wei. (2015) Investigation of structural collapse in unidirectionally freeze cast collagen scaffolds. Journal of Materials Science: Materials in Medicine 27:1.
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Roberto A. Depaz, Swapnil Pansare & Sajal Manubhai Patel. (2016) Freeze-Drying Above the Glass Transition Temperature in Amorphous Protein Formulations While Maintaining Product Quality and Improving Process Efficiency. Journal of Pharmaceutical Sciences 105:1, pages 40-49.
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Bingquan Wang, Timothy R. McCoy, Michael J. Pikal & Dushyant Varshney. 2015. Lyophilized Biologics and Vaccines. Lyophilized Biologics and Vaccines 121 156 .
Hiromasa Hara, Miho Tagiri, In-Sul Hwang, Masato Takahashi, Masumi Hirabayashi & Shinichi Hochi. (2014) Adverse effect of cake collapse on the functional integrity of freeze-dried bull spermatozoa. Cryobiology 68:3, pages 354-360.
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Kristyn Greco, Mircea Mujat, Kristin L. Galbally-Kinney, Daniel X. Hammer, R. Daniel Ferguson, Nicusor Iftimia, Phillip Mulhall, Puneet Sharma, William J. Kessler & Michael J. Pikal. (2013) Accurate Prediction of Collapse Temperature using Optical Coherence Tomography-Based Freeze-Drying Microscopy. Journal of Pharmaceutical Sciences 102:6, pages 1773-1785.
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Kathrin Schersch, Ortrud Betz, Patrick Garidel, Silke Muehlau, Stefan Bassarab & Gerhard Winter. (2012) Systematic Investigation of the Effect of Lyophilizate Collapse on Pharmaceutically Relevant Proteins, Part 2: Stability During Storage at Elevated Temperatures. Journal of Pharmaceutical Sciences 101:7, pages 2288-2306.
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Lavinia M. Lewis, Robert E. Johnson, Megan E. Oldroyd, Saleem S. Ahmed, Liji Joseph, Ilie Saracovan & Sandipan Sinha. (2010) Characterizing the Freeze–Drying Behavior of Model Protein Formulations. AAPS PharmSciTech 11:4, pages 1580-1590.
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Andrew Parker, Shellie Rigby-Singleton, Mark Perkins, David Bates, Delphine Le Roux, Clive J. Roberts, Claire Madden-Smith, Lavinia Lewis, Dirk L. Teagarden, Robert E. Johnson & Saleem S. Ahmed. (2010) Determination of the Influence of Primary Drying Rates on the Microscale Structural Attributes and Physicochemical Properties of Protein Containing Lyophilized Products. Journal of Pharmaceutical Sciences 99:11, pages 4616-4629.
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Robert E. Johnson, Megan E. Oldroyd, Saleem S. Ahmed, Henning Gieseler & Lavinia M. Lewis. (2010) Use of Manometric Temperature Measurements (MTM) to Characterize the Freeze-Drying Behavior of Amorphous Protein Formulations. Journal of Pharmaceutical Sciences 99:6, pages 2863-2873.
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K. Schersch, O. Betz, P. Garidel, S. Muehlau, S. Bassarab & G. Winter. (2010) Systematic investigation of the effect of lyophilizate collapse on pharmaceutically relevant proteins I: Stability after freeze‐drying. Journal of Pharmaceutical Sciences 99:5, pages 2256-2278.
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Eva Meister & Henning Gieseler. (2009) Freeze-Dry Microscopy of Protein/Sugar Mixtures: Drying Behavior, Interpretation of Collapse Temperatures and a Comparison to Corresponding Glass Transition Data. Journal of Pharmaceutical Sciences 98:9, pages 3072-3087.
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STEFAN C. SCHNEID, HENNING GIESELER, WILLIAM J. KESSLER & MICHAEL J. PIKAL. (2009) Non-Invasive Product Temperature Determination during Primary Drying using Tunable Diode Laser Absorption Spectroscopy. Journal of Pharmaceutical Sciences 98:9, pages 3406-3418.
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Ioan Cristian Trelea, Stéphanie Passot, Michèle Marin & Fernanda Fonseca. (2009) Model for Heat and Mass Transfer in Freeze-Drying of Pellets. Journal of Biomechanical Engineering 131:7.
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Julieta Ortiz, Umesh S. Kestur, Lynne S. Taylor & Lisa J. Mauer. (2009) Interaction of Environmental Moisture with Powdered Green Tea Formulations: Relationship between Catechin Stability and Moisture-Induced Phase Transformations. Journal of Agricultural and Food Chemistry 57:11, pages 4691-4697.
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Eva Meister, Slobodan Šaši & Henning Gieseler. (2009) Freeze-Dry Microscopy: Impact of Nucleation Temperature and Excipient Concentration on Collapse Temperature Data. AAPS PharmSciTech 10:2, pages 582-588.
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