Yokogawa Fluid Imaging Technologies announces the release of the FlowCam® LO, the first and only light obscuration (LO) instrument with imaging capabilities. This easy-to-use instrument combines Flow Imaging Microscopy (FIM) with LO to deliver a powerful, all-in-one solution that meets compliance standards while allowing verification with high-resolution images.
Regulatory agencies have long made clear that orthogonal particle characterization methods are necessary, especially for protein-based biologics since size and counts from LO alone are not adequate to ensure product quality and stability. The FlowCam LO fulfills this need, while providing a single USP-compliant software package for acquisition and analysis of multiple data sets and reporting via VisualSpreadsheet Software.
Over the past ten years FIM has become one of the essential tools used in the biopharmaceutical industry due to its ability to accurately identify and classify subvisible particles in liquid media. With automated high-resolution imaging, particle identification and morphology are confidently and readily determined and displayed in real-time, speeding up formulation development.
By contrast, QC departments have long relied on the legacy method of light obscuration to provide particle size and count data for product release, as most pharmacopeias and related regulations have historically been written around this technique. With the FlowCam LO, a single solution bridges the gap between product formulation and QA/QC requirements.
Customers are looking for ways to speed drug development while also adhering to increased regulatory requirements. The FlowCam LO brings together two critical particle characterization techniques in a single platform to meet this demand. We are very excited to be doing our part to provide this much needed solution to the market.”
Ross Bryant, President and CEO
Content Source: https://www.news-medical.net/news/20210929/The-new-FlowCamc2ae-LO-improves-particle-characterization-in-drug-development.aspx