Fluid Imaging Technologies have made available details of a study showing the efficacy of their FlowCam Nano instrument for characterising and quantifying nano-and microparticles in therapeutic protein products.
The FlowCam Nano, from Fluid Imaging Technologies, is a dynamic imaging nanoparticle and microparticle analysis system designed for sub-visible particle analysis, especially in protein therapeutic studies. It utilises patented oil immersion flow microscopy to deliver high-resolution images of particles from 300 nm to 30 µm in size in liquid samples. In addition to permitting relative quantification of intrinsic, extrinsic, and inherent particles in parental drugs the morphological data can identify the structure and nature of contaminants, thereby improving product development.
A recent study has shown the applicability of the FlowCam Nano to provide counts, sizes and images of nano-and microparticles in a therapeutic protein pumping study. The FlowCam Nano’s capability to assess both micron-sized and submicron particles was found to be particularly valuable. In one instance the peristaltic pumping study showed that relatively high levels of both nano-and microparticles formed when intravenous immunoglobulin (IVIG) formulations were pumped.
During post-pumping agitation there was a substantial increase in microparticle concentrations, which coincided with a large depletion of nanoparticles. The inference being that agglomeration was occurring. A similar result was obtained when IVIG was pumped in different buffers: PBS or glycine. The IVIG colloid is less stable in PBS and presumably, particles of the protein are also. During agitation of pumped IVIG the FlowCam Nano indicated that diameter of particles increased more rapidly in the PBS sample than the glycine buffered sample.
Overall, the researchers concluded that their study demonstrated that the FlowCam Nano has particular capabilities that are highly effective for characterising and quantifying nano and microparticles in therapeutic protein products, as well as for gaining insights into the effects of processing steps and formulations.
The FlowCam Nano is available in the UK from Meritics.
Full details of the study can be downloaded here. Just click on the link below to access the file.