Particle characterization from nanometer to the visible size range.
Coriolis is a leading contract laboratory providing analytical services for particle characterization. Particles are potentially present in all biopharmaceutical samples and can originate from various sources. Particles can:
- directly derive from the API (active pharmaceutical ingredient e.g., an insufficiently stable protein therapeutic)
- be introduced by formulation excipients (e.g., as degradation products or particulate impurities)
- be generated by the production process (e.g., pump or filter shed).
Particles occur in various sizes, ranging from a few nanometers up to millimeters, thus spanning over 5 log scales. This is the same size difference as between a footprint and the comet Hale-Bopp.
Why is particle characterization so crucial?
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 for:
- In-depth particle characterization
- Particle identification
- Comprehensive troubleshooting activities
Explore our particle characterization techniques and get in touch with our experts to find out how a comprehensive particle characterization can be achieved for your sample.
We offer a number of particle characterization services also under GMP.