Characterization of Protein Aggregates in Parenteral Drug with Imaging Particle Analysis
The FlowCAM imaging particle analysis system allows you to simultaneously count and classify particles in your therapeutic protein formulations and vaccines - and provides you with the critical data you need to ensure product safety. The FlowCAM overcomes the limitation of particle counters, while giving additional particle information typically only found by using microscopy. Plus, imaging particle analysis provides a much more detailed look at the particulates than does classical light obscuration technologies used to comply with USP method <788>.
Particulates in parenteral drug development have always been a serious issue. In biopharmaceuticals the issue is compounded by reported impacts of aggregates and particles on the product’s efficacy, safety, and immunogenicity. FDA regulations strongly recommend in-depth characterization of the identity and quantity of particles in protein therapeutics. Particle concerns are increasingly common in FDA submissions, and in some cases, particle matters have resulted in drug recalls.
Image quality is extremely important when characterizing, identifying, and differentiating particles such as protein aggregates, silicone oil, air bubbles, and other contaminants, and it is essential for accurate sizing measurements. Blurry particles produce a relatively lower count and concentration compared to “sharp” particles. Poor characterization creates a wider variation in measurements, and can lead to higher rates of false positives, false negatives, as well as a lower statistical confidence.
FlowCAM represents a powerful tool with unique features for detecting, counting, and characterizing protein aggregates and other particles in parenteral drug formulations.
Benefits of the FlowCAM
Characterizing Biologics Using Dynamic Imaging Particle Analysis >>
Flow Imaging of Subvisible Protein Particles: Moving Towards Best Practices >>
The Importance of Thresholding in Imaging Analysis of Protein Aggregates >>
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See the FlowCAM in Action!
This quick video will show you how the FlowCAM works and acquires data!