Particle Characterisation in Biotherapeutics
Particle content is a critical quality attribute for many biologics that must be monitored to meet regulatory requirements like USP <788> and mitigate product safety risks.
Flow imaging microscopy is an established technique recommended by USP <1788> for subvisible and submicron particle analysis, revealing particle count, size, and shape, indicating their type and source.
Monitor the aggregation of adjuvants, nano-drug delivery systems, and other small particles to larger, potentially concerning, submicron and subvisible particles.
Use FlowCam to:
- Detect aggregation and agglomeration of the active pharmaceutical ingredient (API) and drug delivery vehicles to improve product stability
- Obtain images and particle morphology information not obtainable from orthogonal techniques to assess product degradation
- Differentiate between inherent particles, intrinsic particles like glass flakes and silicone oil droplets, and extrinsic contaminants
- Optimize and control particulates in your formulation
FlowCam – A Flexible Particle Analysis Solution
Apply flow imaging microscopy techniques to therapeutics including aggregates of drug delivery systems like liposomes, exosomes, and gold nanoparticles, and vaccine components like virus-like particles and adjuvants.
FlowCam is ideally suited to analyze samples containing larger particles like CHO cells, cell cultures and associated particles like Dynabeads™ and Tentagel™ beads, and hydrogel spheres.
Obtain size and morphology information of these particles that is related to product quality issues such as cell viability, misshapen drug delivery vehicles, and the form of any aggregates present.
- Improving vaccine formulations by monitoring API and adjuvant aggregation
- Characterising large liposome, exosome, and other drug delivery platform morphology with an automated microscopy technique
- Optimizing cell concentrations and viability during biotherapeutic manufacturing
- Observing Dynabead binding and measuring unbound bead concentrations in cell culture applications
