Publications by authors named "Pierre Goldbach"

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Best Practices for Microbial Challenge In-Use Studies to Evaluate the Microbial Growth Potential of Parenteral Biological Products; Industry and Regulatory Considerations.
Camellia Zamiri, Danielle L Leiske, Patricia Hughes, J Paul Kirwan, Evelyn Der, Pierre Goldbach

PDA J Pharm Sci Technol· August 2024

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An Industry Perspective on Compatibility Assessment of Closed System Drug-Transfer Devices for Biologics.
Ahmed Besheer, Lori Burton, Richard J Galas, Kedar Gokhale, Pierre Goldbach

J Pharm Sci· February 2021

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Impact of dextran on thermal properties, product quality attributes, and monoclonal antibody stability in freeze-dried formulations.
Christina Haeuser, Pierre Goldbach, Joerg Huwyler, Wolfgang Friess, Andrea Allmendinger

Eur J Pharm Biopharm· February 2020

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Excipients for Room Temperature Stable Freeze-Dried Monoclonal Antibody Formulations.
Christina Haeuser, Pierre Goldbach, Joerg Huwyler, Wolfgang Friess, Andrea Allmendinger

J Pharm Sci· January 2020

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Be Aggressive! Amorphous Excipients Enabling Single-Step Freeze-Drying of Monoclonal Antibody Formulations.
Christina Haeuser, Pierre Goldbach, Joerg Huwyler, Wolfgang Friess, Andrea Allmendinger

Pharmaceutics· November 2019

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Imaging Techniques to Characterize Cake Appearance of Freeze-Dried Products.
Christina Haeuser, Pierre Goldbach, Joerg Huwyler, Wolfgang Friess, Andrea Allmendinger

J Pharm Sci· November 2018

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Solid-State Hydrogen-Deuterium Exchange Mass Spectrometry: Correlation of Deuterium Uptake and Long-Term Stability of Lyophilized Monoclonal Antibody Formulations.
Balakrishnan S Moorthy, Isidro E Zarraga, Lokesh Kumar, Benjamin T Walters, Pierre Goldbach

Mol Pharm· January 2018

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Mannitol/l-Arginine-Based Formulation Systems for Freeze Drying of Protein Pharmaceuticals: Effect of the l-Arginine Counter Ion and Formulation Composition on the Formulation Properties and the Physical State of Mannitol.
Peter Stärtzel, Henning Gieseler, Margit Gieseler, Ahmad M Abdul-Fattah, Michael Adler, Pierre Goldbach

J Pharm Sci· October 2016

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Physico-chemical Stability of MabThera Drug-product Solution for Subcutaneous Injection under in-use Conditions with Different Administration Materials.
Claudia Mueller, Elke Dietel, Severin R Heynen, Heiko Nalenz, Pierre Goldbach

Int J Pharm Compd· February 2016

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Freeze-Drying of L-Arginine/Sucrose-Based Protein Formulations, Part 2: Optimization of Formulation Design and Freeze-Drying Process Conditions for an L-Arginine Chloride-Based Protein Formulation System.
Peter Stärtzel, Henning Gieseler, Margit Gieseler, Ahmad M Abdul-Fattah, Michael Adler, Pierre Goldbach

J Pharm Sci· December 2015

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Freeze drying of L-arginine/sucrose-based protein formulations, part I: influence of formulation and arginine counter ion on the critical formulation temperature, product performance and protein stability.
Peter Stärtzel, Henning Gieseler, Margit Gieseler, Ahmad M Abdul-Fattah, Michael Adler, Pierre Goldbach

J Pharm Sci· July 2015

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In-use physicochemical and microbiological stability of biological parenteral products.
Margaret Speed Ricci, Michelle Frazier, Jamie Moore, Mary Cromwell, William J Galush, Pierre Goldbach

Am J Health Syst Pharm· March 2015

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Analytical protein a chromatography as a quantitative tool for the screening of methionine oxidation in monoclonal antibodies.
Caroline Loew, Constanze Knoblich, Jürgen Fichtl, Nadja Alt, Katharina Diepold, Pierre Goldbach

J Pharm Sci· November 2012

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