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4. Industry Perspective on the Use and Characterization of Polysorbates for Biopharmaceutical Products Part 2: Survey Report on Control Strategy Preparing for the Future

Author

Wuchner, Klaus, Yi, Linda, Chery, Cyrille, Nikels, Felix, Junge, Friederike, Crotts, George, Rinaldi, Gianluca, Starkey, Jason A., Bechtold-Peters, Karoline, Shuman, Melissa, Leiss, Michael, Jahn, Michael, Garidel, Patrick, de Ruiter, Rien, Richer, Sarah M., Cao, Shawn, Peuker, Sebastian, Huille, Sylvain, Wang, Tingting, and Brun, Virginie Le

Published
2022
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5. Industry Perspective on the use and Characterization of Polysorbates for Biopharmaceutical Products Part 1: Survey Report on Current State and Common Practices for Handling and Control of Polysorbates

Author

Wuchner, Klaus, Yi, Linda, Chery, Cyrille, Nikels, Felix, Junge, Friederike, Crotts, George, Rinaldi, Gianluca, Starkey, Jason A., Bechtold-Peters, Karoline, Shuman, Melissa, Leiss, Michael, Jahn, Michael, Garidel, Patrick, de Ruiter, Rien, Richer, Sarah M, Cao, Shawn, Peuker, Sebastian, Huille, Sylvain, Wang, Tingting, and Le Brun, Virginie

Published
2022
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10. A Multicompany Assessment of Submicron Particle Levels by NTA and RMM in a Wide Range of Late-Phase Clinical and Commercial Biotechnology-Derived Protein Products

Author

Hubert, Mario, Yang, Dennis T., Kwok, Stanley C., Rios, Anacelia, Das, Tapan K., Patel, Ankit, Wuchner, Klaus, Antochshuk, Valentyn, Junge, Friederike, Bou-Assaf, George M., Cao, Shawn, Saggu, Miguel, Montrond, Luis, Afonina, Nataliya, Kolhe, Parag, Loladze, Vakhtang, and Narhi, Linda

Published
2020
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15. Subvisible (2–100 μm) particle analysis during biotherapeutic drug product development: Part 2, experience with the application of subvisible particle analysis

Author

Corvari, Vincent, Narhi, Linda O., Spitznagel, Thomas M., Afonina, Nataliya, Cao, Shawn, Cash, Patricia, Cecchini, Irene, DeFelippis, Michael R., Garidel, Patrick, Herre, Andrea, Koulov, Atanas V., Lubiniecki, Tony, Mahler, Hanns-Christian, Mangiagalli, Paolo, Nesta, Douglas, Perez-Ramirez, Bernardo, Polozova, Alla, Rossi, Mara, Schmidt, Roland, Simler, Robert, Singh, Satish, Weiskopf, Andrew, and Wuchner, Klaus

Published
2015
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30. Classification of glass particles in parenteral product vials by visual, microscopic, and spectroscopic methods.

Author

Li GG, Cao S, Jiao N, and Wen ZQ

Subjects
Manufactured Materials, Microscopy, Electron, Scanning, Surface Properties, Drug Delivery Systems, Drug Packaging, Glass chemistry
Abstract

Glass vials have been used as primary containers for parenteral drugs including biopharmaceuticals. Different types of glass-related particles, although in low occurrence rate, may be adventitiously introduced in these parenterals. Proper classification and investigations of these glass-related particles may help to understand their formation, improve process control, reduce glass-related particles, and deliver safe parenteral drugs to patients. In this article, we introduced a classification scheme, and identification procedures and methods, for the glass-related particles. We propose to classify them as glass chip, glass lamella/flake, and silica gel. Eight characteristics for each glass particle type have been identified and described for the visual inspection method. The limitations of the visual method and the need to correlate visual results with forensic analysis are discussed. Using representative examples from each type of glass particle, this study summarized their forensic differentiations based on microscopic methods of optical microscopy, scanning electron microscopy, micro-flow imaging, and spectroscopic methods of dnergy-dispersive spectroscopy and Fourier transform infrared spectroscopy. The mechanisms of glass particle formation are listed as references for drug development scientists to investigate the root causes and improve process control on visible glass particles in parenteral vials., Lay Abstract: Glass vials have been used as primary containers for parenteral drugs including biopharmaceuticals. Different types of glass-related particles, although in low occurrence rate, may be adventitiously introduced in these parenterals. Proper classification and investigations of these glass-related particles may help to understand their formation, improve process control, reduce glass-related particles, and deliver safe parenteral drugs to patients. In this article, we introduced a classification scheme, and identification procedures and methods, for the glass-related particles. We propose to classify them as glass chip, glass lamella/flake, and silica gel. Using representative examples from each type of glass particle, this study summarized their forensic differentiations based on microscopic and spectroscopic methods. The mechanisms of glass particle formation are listed as references for drug development scientists to investigate the root causes and improve process control on visible glass particles in parenteral vials., (© PDA, Inc. 2014.)

Published
2014
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