Measuring and monitoring particulate matter present in injectable drugs is extremely important to companies involved in formulation development, manufacturing and packaging. Adverse effects caused by visible and subvisible particles have been well- documented over the years. The risks range from reduced efficacy to significant immunogenic responses.
"Until recently, even the most advanced technology available had trouble detecting and counting particles smaller than 10 microns," says Kent Peterson, CEO, Fluid Imaging Technologies. "Lacking the technological ability to do so, it becomes easier to understand why many pharmaceutical scientists drew the line of concern at 10 microns and larger."
|An oil immersion flow imaging microscope provides for a much higher index of refraction and yields higher resolution than previously available. Detection, counting and characterization of particulate matter is now possible in the 300 nm to 10 µm range.|
A recently published article describes Nano-Flow Imaging, the new technology employed by the FlowCam Nano that images particles from 300 nm to 10 um, and its applications in biopharmaceutical research and development.
Read more mentions of FlowCam technology in other publications in our FlowCam In The News section of our website.