Identifying visible and subvisible particles in (bio)pharmaceutical samples
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 API or issues with the production process and can negatively influence the safety and efficacy of the therapy. Particles can originate from various sources:
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).
Particle identification for samples up to biosafety level S2
Determining the origin and identity of foreign particulate matter in (bio)pharmaceuticals is crucial for troubleshooting and root-cause analysis. In a first step, the presence of particles is inspected in the primary container by:
High-resolution photo documentation