Stability Studies
Cryo-TEM is a key tool in determining the stability of final drug formulations
Visualizing critical attributes such as particle size, morphology, and distribution provides insight into the physical characteristics of formulations over time and under different storage conditions (time, pH, buffer, and more), helping to identify any changes or degradation that may occur. Monitoring these parameters can help optimize formulation stability, ensuring that final formulations maintain their integrity and efficacy throughout their shelf life.
What Stability Studies Reveal
Cryo-TEM can also help evaluate the influence of storage conditions on nanoparticle morphology:
- Impact of temperature on particle structure over time
- Changes in particle size distribution under stress conditions
- Cargo leakage or structural transitions
- Aggregation or fusion events
- Membrane degradation or lipid phase separation
Cryo-TEM image of lipid nanoparticles (LNPs) stored at 4°C for 10 weeks
