The Coulter Principle for Analysis of Subvisible Particles in Protein Formulations
โ Scribed by Matthew N. Rhyner
- Book ID
- 111767698
- Publisher
- American Association of Pharmaceutical Scientists
- Year
- 2010
- Tongue
- English
- Weight
- 168 KB
- Volume
- 13
- Category
- Article
- ISSN
- 1550-7416
No coin nor oath required. For personal study only.
๐ SIMILAR VOLUMES
The amount, identity, and size distribution of particles in parenteral therapeutic protein formulations are of immense interest due to potential safety and efficacy-related implications. In this communication, we describe the use of a flow cytometer equipped with forward- and side-scattering as well
Concern around the lack of monitoring of proteinaceous subvisible particulates in the 0.1-10 mm range has been heightened (Carpenter et al., 2009, J Pharm Sci 98: 1202-1205), primarily due to uncertainty around the potential immunogenicity risk from these particles. This article, representing the op