The state-of-the-art particle lab is able to characterize subvisible and submicron particles using complementary methods covering the entire nano and micro-particle ranges, such as: dynamic light scattering (DLS), static light scattering (SLS), asymmetric flow field flow fractionation (AF4), nanoparticle tracking analysis (NTA), resonant mass measurement (RMM), Coulter counter (CC), microflow imaging (MFI), light obscuration (LO), scanning electron microscopy (SEM), and visual inspection.
The particle lab can help design an adequate subvisible and submicron particle-control strategy including specification setting to meet current health authority requirements and beyond.
Together with the particle lab, the forensic chemistry group offers fast-track particle contamination root cause investigations in drug product processing and manufacturing and provides best inputs into regulatory filings and questions.