Particles in the visible and subvisible size range can appear in (bio)pharmaceutical samples and drug products during all stages of development and even after market approval. The presence of particles can indicate an insufficient stability of the active pharmaceutical ingredient or issues with the production process and can negatively influence the safety and efficacy of the therapy. Particles can:

• directly derive from the active pharmaceutical ingredient (API) e.g., due to an insufficiently stable therapeutic protein
• be introduced by formulation excipients e.g., as degradation products or particulate impurities
• be generated by the production process e.g., during pumping or filtration steps

Particle identification for trouble shooting with a quick turnaround time

Determining the origin and identity of particulate matter in (bio)pharmaceutical drug products is crucial for troubleshooting and root-cause analysis and, thus, often very time-critical. In such situations, Coriolis can analyze your samples with minimal lead time and deliver results right from the lab bench, so you can resolve the underlying cause of particle formation as quickly as possible.

Our identification approach includes the visual inspection of the sample inside the primary container, a high-resolution photo documentation of the particles and a subsequent identification of the isolated particles by a range of specialized analytical techniques, including FTIR microscopy, SEM-EDX and Raman.

In a first step, the presence of particles is inspected in the primary container by:

• Visual inspection
• High-resolution photo documentation

This gives an overall picture on the extent of particle contamination and enables the selection of samples for further analysis. In a second step, particles are isolated on a filter, preferably a metal-coated membrane or a gold filter, for subsequent identification with an array of specialized analytical techniques:

• Light microscopy
• FTIR microscopy
• Raman microscopy
• SEM-EDS

An identification approach can be successful for particles larger than around 10 µm. Under certain circumstances, identification of particles suspended in liquid formulation (without prior isolation on a filter) may also be possible.