Applying Intelligent Flow Microscopy to Biotechnology

June 2009 Ongoing requirements for additional insight and CGMPcompliant measurement have led to interest in new technologies that can be applied to the analysis of many different types of particle-containing fluids. Micro-Flow imaging (MFI) is a robust, versatile, and intelligent vision technology that is increasingly used for evaluating populations of microparticles encountered during bioformulation development (1). It is also being accepted in fill–finish processes and many other biotechnology applications. Features of MFI technology that have contributed to its rising popularity include the direct insight provided by imaging, a superior sensitivity for neartransparent particles, ease of use, and flexibility in resolving and independently analyzing different particle types present in heterogeneous populations. For example, the technology is used to quantify transparent protein aggregates of various morphologies that can coexist with silicone droplets, air bubbles, micelles, and a variety of foreign contaminants. The MFI technique can be used to detect, evaluate, classify, and independently enumerate the different particle types present.