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:
- Visual inspection
- High-resolution photo documentation
This gives an overall picture on the extend 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
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.
Coriolis is your expert partner for analytical services
As a leading contract laboratory for analytical services, Coriolis offers cutting edge analytical techniques for particle identification for samples up to biosafety level S2. We combine a trouble-shooting mindset with a strong client focus.
Particle identification is offered as a stand-alone service or as part of a formulation development program. Contact our experts today to find out how a particle identification can support your drug development program.