New Biopharmaceutical Study Confirms Need for Hi-Res Nanoparticle Imaging in Therapeutic Protein Product Development, Production

U of CO Professor Sees Nanoparticles Form Microparticles With New Nano-Flow Imaging(TM) Technology

Scarborough, ME: A new study concludes that Nano-Flow Imaging(TM) technology developed, patented and applied as the FlowCam Nano® by global laboratory instrumentation manufacturer Fluid Imaging Technologies, Scarborough, Maine, effectively generates highly resolved, digital images of thousands of individual nanoparticulates and microparticulates in seconds simultaneously, automatically and in real-time. Led by Professor John F. Carpenter and Cheng Her, University of Colorado Denver - Anschutz Medical Campus, and presented at the 2017 Colorado Protein Stability Conference in Breckenridge, Colorado, the study used the FlowCam Nano to examine particulate morphology and formation during fill operations and documented that a significant increase in microparticle concentration coincided with a significant decrease in nanoparticle concentration. This points to agglomeration as the likely culprit in the post-pumping formation of potentially dangerous large particles in therapeutic protein products.

In the study assessing drug substance and drug product stability, researchers also compared the colloidal stability of different parenteral drug product formulations during filling operations and accelerated degradation trials. By imaging and measuring both micron- and submicron-sized particles within IVIG in PBS glycine buffer using the FlowCam Nano, Carpenter and his team documented differences in particle size distributions, concluding the FlowCam can effectively assess differences in the colloidal stability of different formulations.

The FlowCam Nano is the world's first particle analyzer to automatically detect, image and measure nanoparticles ranging in size from 300 nm to 10 µm in a sample to allow for measurements and identification with unprecedented speed, resolution and accuracy. The FlowCam measures more than 40 different parameters from size, count and concentration to color, grayscale and morphological characteristics such as circularity, elongation and fiber curl.

For more information, contact Fluid Imaging Technologies, Inc.; 200 Enterprise Drive, Scarborough, Maine 04074; 207.289.3200.; Fax 207.289.3101; www.fluidimaging.com.

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