Innovative subvisible particle characterization with FlowCam LO combines Light Obscuration with Flow Imaging Microscopy into a single analytical solution.
Monitoring particles in biotherapeutics is critical to assess product quality, meet regulatory guidelines, and ensure product safety and efficacy. USP <787> and <788> regulations require the use of light obscuration (LO) to detect these particles. However, it can be challenging to detect translucent particles with light obscuration.
Flow imaging microscopy is a highly sensitive orthogonal technique to light obscuration to analyze translucent particles per USP <1788>. The high-quality microscopic images of particles help identify and control particle sources to maximize the quality of drug products from development to manufacturing.
