From nanoparticle characterization to visual inspection – Coriolis is a leading contract laboratory providing analytical services for particle characterization.
Particles, which are potentially present in a biopharmaceutical sample, can originate from various sources. They can directly derive from the active pharmaceutical ingredient (API, e.g., an insufficiently stable protein therapeutic), be introduced by formulation excipients (e.g., as degradation products or particulate impurities), or generated by the production process (e.g., pump or filter shed). Particles can also occur in various sizes, ranging from a few nanometers up to a millimeter, thus spanning over 5 log scales. This is the same size difference as between a footprint and the comet Hale-Bopp.
The presence of particles can on one hand indicate an insufficient stability of the API or issues with the production process, on the other hand, can negatively influence the safety and efficacy of the therapy.
We at Coriolis offer a large portfolio of cutting-edge instruments, enabling the orthogonal analysis of particles of all sizes. We also offer in-depth particle characterization and identification as well as comprehensive troubleshooting activities.
Explore our analytical techniques and get in touch with our experts, to find out how a comprehensive particle characterization can be achieved for your sample.
S. Zölls, R. Tantipolphan, M. Wiggenhorn, G. Winter, W. Jiskoot, W. Friess, A. Hawe, Particles in therapeutic protein formulations, Part 1: overview of analytical methods., J. Pharm. Sci. 101  914–35. doi:10.1002/jps.23001.