Publications by authors named "Gregory Sacha"

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The graphical design space for the primary drying phase of freeze Drying: Factors affecting the dried product layer resistance.
Jayasree M Srinivasan, Gregory A Sacha, Steven L Nail

Int J Pharm· January 2023

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Mannitol hemihydrate in lyophilized protein formulations:Impact of its dehydration during storage on sucrose crystallinity and protein stability.
Jayesh Sonje, Seema Thakral, Brendan Mayhugh, Gregory Sacha, Steve Nail

Int J Pharm· August 2022

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Recommended Best Practices for Lyophilization Validation 2021 Part II: Process Qualification and Continued Process Verification.
Feroz Jameel, Alina Alexeenko, Akhilesh Bhambhani, Gregory Sacha, Tong Zhu

AAPS PharmSciTech· November 2021

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Correction to: Recommended Best Practices for Lyophilization Validation-2021 Part I: Process Design and Modeling.
Feroz Jameel, Alina Alexeenko, Akhilesh Bhambhani, Gregory Sacha, Tong Zhu

AAPS PharmSciTech· October 2021

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Recommended Best Practices for Lyophilization Validation-2021 Part I: Process Design and Modeling.
Feroz Jameel, Alina Alexeenko, Akhilesh Bhambhani, Gregory Sacha, Tong Zhu

AAPS PharmSciTech· August 2021

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Stability of antibody drug conjugate formulations evaluated using solid-state hydrogen-deuterium exchange mass spectrometry.
Eunbi Cho, Brendan M Mayhugh, Jayasree M Srinivasan, Gregory A Sacha, Steven L Nail

J Pharm Sci· June 2021

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Equipment Capability Measurement of Laboratory Freeze-Dryers: a Comparison of Two Methods.
Jayasree M Srinivasan, Gregory A Sacha, Vaibhav Kshirsagar, Alina Alexeenko, Steven L Nail

AAPS PharmSciTech· January 2021

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Freeze-Dryer Equipment Capability Limit: Comparison of Computational Modeling With Experiments at Laboratory Scale.
Gayathri Shivkumar, Vaibhav Kshirsagar, Tong Zhu, Israel B Sebastiao, Steven L Nail, Gregory A Sacha

J Pharm Sci· September 2019

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Process and Formulation Effects on Protein Structure in Lyophilized Solids Using Mass Spectrometric Methods.
Lavanya K Iyer, Gregory A Sacha, Balakrishnan S Moorthy, Steven L Nail, Elizabeth M Topp

J Pharm Sci· May 2016

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Pre-filled syringes: a review of the history, manufacturing and challenges.
Gregory Sacha, J Aaron Rogers, Reagan L Miller

Pharm Dev Technol· January 2015

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Quality by design in formulation and process development for a freeze-dried, small molecule parenteral product: a case study.
Linas N Mockus, Timothy W Paul, Nathan A Pease, Nancy J Harper, Prabir K Basu, Gregory A Sacha

Pharm Dev Technol· March 2012

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Practical fundamentals of glass, rubber, and plastic sterile packaging systems.
Gregory A Sacha, Wendy Saffell-Clemmer, Karen Abram, Michael J Akers

Pharm Dev Technol· October 2010

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Thermal analysis of frozen solutions: multiple glass transitions in amorphous systems.
Gregory A Sacha, Steven L Nail

J Pharm Sci· September 2009

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Rapid determination of vial heat transfer parameters using tunable diode laser absorption spectroscopy (TDLAS) in response to step-changes in pressure set-point during freeze-drying.
Wei Y Kuu, Steven L Nail, Gregory Sacha

J Pharm Sci· March 2009

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Identification of critical process variables affecting particle size following precipitation using a supercritical fluid.
Gregory A Sacha, William J Schmitt, Steven L Nail

Pharm Dev Technol· October 2006

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Identification of physical-chemical variables affecting particle size following precipitation using a supercritical fluid.
Gregory A Sacha, William J Schmitt, Steven L Nail

Pharm Dev Technol· October 2006

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