The ultimate goal of the Phase I SBIR project is to establish the feasibility of using ion mobility spectrometry (IMS) or liquid chromatography-IMS (LC-IMS) as a fast, selective and sensitive method for rapid monitoring of bio manufacturing processes for on-line use to improve the understanding of the process and provide real-time feedback. Excellims will develop the LC-IMS method for monitoring the most important chemical species that inform the process monitors. Bio manufacturers are limited by current real-time monitoring tools and must determine quality after the product is completed. Therefore, successful development of the method will fulfill the need for tools that increase the efficiency of the entire process that will translate into operational and cost savings for mass producing biologics.
Ion Mobility Spectrometry (IMS) has been developed as a powerful separation and analysis method for organic and biological samples that can be used for monitoring at a field location. Combining the advantages of IMS in speed and simplicity will enable a new application of the technique for real-time, on-site monitoring at a biotherapeutic manufacturing facility. Development of the new application for bio manufacturing process monitoring will provide innovative methods for improving the efficiency of the process controls and for determining the production end-points.