Improved particle characterization in drug development
New tech is aimed at providing the biopharma industry with a single instrument to meet compliance standards and verify data with images.
Yokogawa Fluid Imaging Technologies is introducing FlowCam LO to the market; it calls it 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.”
The FlowCam LO, it continued, 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,” said Ross Bryant, CEO, Yokogawa.