2023 |
Michael J. Sadowski and Stephen E. Langille |
Parametric Release of Moist Heat Sterilized Products: History and Current State |
2022 |
Julian Lenger, Raimund Geidobler, Werner Halbinger, Ingo Presser, and Gerhard Winter |
100% Control of Controlled Ice Nucleation Vials by Camera-Supported Optical Inspection in Freeze-Drying |
2021 |
Liang Fang, Coralie Adele Richard, Galen Huaiqiu Shi, Xia Dong, Marissa Rase, Tingting Wang |
Physicochemical Excipient-Container Interactions in Prefilled Syringes and Their Impact on Syringe Functionality |
2020 |
Marine Marius, Frédéric Vacher, Thierry Bonnevay |
Comparison of Limulus Amoebocyte Lysate and Recombinant Factor C Assays for Endotoxin Detection in Four Human Vaccines with Complex Matrices |
2019 |
Philippe Lam, Thomas W. Patapoff |
Split-Cakes, Still Delicious |
2018 |
Aaron Hubbard, Thomas Roedl, Ada Hui, Stephanie Knueppel, Kirk Eppler, Siegfried Lehnert, and Yuh-Fun Maa |
Vapor Phase Hydrogen Peroxide Decontamination or Sanitization of an Isolator for Aseptic Filling of Monoclonal Antibody Drug Product—Hydrogen Peroxide Uptake and Impact on Protein Quality |
2017 |
Christopher Timmons, Chi Yuen Liu, and Stefan Merkle |
Particulate Generation Mechanisms during Bulk Filling and Mitigation via New Glass Vial |
2016 |
Patricia Cash, Stephan Krause, Sophia Levitskaya-Seaman, Maryam Mazaheri, Derek Murphy, and Roja Narwal |
Semi-Quantitative Analysis of Inherent Visible Particles for Biopharmaceutical Products |
2015 |
Mayumi Bowen, Benson Gikanga, Ada Hui, Yuh-Fun Maa, Oliver B. Stauch, and Robert Turok |
Manufacturing of High-Concentration Monoclonal Antibody Formulations via Spray Drying—the Road to Manufacturing Scale |
2014 |
Wendy Shieu, Sarah A. Torhan, Edwin Chan, Aaron Hubbard, Benson Gikanga, Oliver B. Stauch and Yuh-Fun Maa |
Filling of High-Concentration Monoclonal Antibody Formulations into Pre-Filled Syringes: Filling Parameter Investigation and Optimization |