PARTICLE IDENTIFICATION

Appearance of particles 

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 or from primary packaging (intrinsic particles) 

• be related to formulation excipients e.g., degradation products (inherent particles) 

• be introduced during the production process e.g., during pumping or filtration steps or by personnel (extrinsic particles)

Troubleshooting with rapid particle identification

Determining the identity and possible origin of particulate matter in (bio)pharmaceutical drug products is crucial for troubleshooting and root-cause analysis and, thus, often very time-critical. Coriolis experts can analyze your samples within a matter of days, if required, so you can resolve the underlying cause of particle formation as quickly as possible. 

We can select the most suitable approach for your particular analytical challenge, whether following a standardized in-house workflow or a custom-tailored solution.

Analytical Methods

Webinars and Publications