This article explores how you can measure particle size CQAs in (sterile) pharmaceutical packaging, and discusses non-invasive measurements using SR-DLS.
The size and size distribution of low turbidity suspensions in various (bio)pharmaceutical products, including liposomes, lipid nanoparticles, recombinant proteins, and antibodies, plays a significant role in their pharmacokinetic and pharmacodynamic profile in vivo. These factors directly influence therapeutic efficacy, immunogenicity, and safety. Consequently, particle size is considered one of the critical quality attributes for such products.
As inline instrument, the NanoFlowSizer is a powerful non-invasive Process Analytical Tool allowing monitoring of nanoparticle size characteristics in processes.
Wet bead milling is used to produce nanoparticles at industrial scales. Continuous monitoring of particle size during comminution would allow real-time end-point determination and critical quality attribute monitoring, reducing operational risk and increasing insight into particle breakage kinetics.