Subvisible (2-100 μm) Particle Analysis During Biotherapeutic Drug Product Development: Part 1, Considerations and Strategy
| Autor: | Irene Cecchini, Paolo Mangiagalli, Robert Simler, Hanns-Christian Mahler, Douglas P. Nesta, Patrick Garidel, Dean C. Ripple, Atanas Koulov, Mara Rossi, Bernardo Perez-Ramirez, Satish K. Singh, Thomas Spitznagel, Alla Polozova, Andrew Weiskopf, Nataliya Afonina, Linda O. Narhi, Andrea Herre, Roland Schmidt, Tony Lubiniecki, Vincent Corvari, Michael Rosario Defelippis, Klaus Wuchner |
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| Rok vydání: | 2014 |
| Předmět: |
Microscopy
Light Chemistry business.industry Protein Stability Drug Compounding Pharmaceutical Science Proteins Nanotechnology Protein Aggregates New product development Drug Discovery Drug product Animals Humans Scattering Radiation Physical stability Biochemical engineering Particle size Particle analysis Particle Size business |
| Zdroj: | Journal of pharmaceutical sciences. 104(6) |
| ISSN: | 1520-6017 |
| Popis: | Measurement and characterization of subvisible particles (defined here as those ranging in size from 2 to 100 μm), including proteinaceous and nonproteinaceous particles, is an important part of every stage of protein therapeutic development. The tools used and the ways in which the information generated is applied depends on the particular product development stage, the amount of material, and the time available for the analysis. In order to compare results across laboratories and products, it is important to harmonize nomenclature, experimental protocols, data analysis, and interpretation. In this manuscript on perspectives on subvisible particles in protein therapeutic drug products, we focus on the tools available for detection, characterization, and quantification of these species and the strategy around their application. |
| Databáze: | OpenAIRE |
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