Particle-analysis technology that yields valuable insight
Protein therapeutics drugs are susceptible to formation of subvisible and visible aggregates. Such aggregates can compromise parenteral drug efficacy and cause undesired side-effects in patients. Therefore, it is critical to accurately monitor and characterize aggregates during formulation development process. The Micro-Flow Imaging™ (MFI™) is the perfect solution for aggregate and particle analysis.
MFI's unique capability for detecting sub-visible particles is recognized as a breakthrough technology for particle analysis. Moreover, the MFI is the world's first automated particle analysis platform. The automation of the MFI minimizes the set-up time and allows unattended operaton.
- MFI yields consistent, precise and repeatable results that help our clients improve their formulations. MFI is scalable and robust, and can be validated for use in cGMP production environments.
- MFI provides powerful, novel and unique insight into particle characterization and quantification with just a single test. Measure protein aggregates and particulates, air bubbles, silicone oil droplets and contaminants in the sub-visible and visible ranges.
- MFI helps users detect and diagnose problems sooner than traditional technology. Identify trend changes in particle populations that traditional technologies—such as light obscuration (LO) and size exclusion chromatography (SEC)—have been demonstrated to miss.
- MFI is easy to operate and completely automated reducing hands-on time and operator to operator variability.
The pharmaceutical industry relies on MFI
The world's ten largest pharmaceutical companies—and 18 of the top 20—use MFI. The technology has been qualified and validated within the industry. And it is regularly referenced by many international regulatory agencies.