Using Flow Imaging Microscopy to Meet Particulate Matter Standards for Biotherapeutics
Speaker: Austin Daniels, PhD
Yokogawa Fluid Imaging Technologies
Duration: 60 Minutes
Particles are ubiquitous in biotherapeutics and have been associated with significant changes in the safety and efficacy of these life-saving medicines. The United States Pharmacopeia (USP) requires researchers to monitor subvisible (2-100 μm) and visible (greater than 100 μm) particles in biologics per USP 788. However, the compendial particle monitoring methods are insensitive to relevant particle types like protein aggregates and offer limited information about particle types and sources.
In this webinar, we will introduce flow imaging microscopy (FIM), an analytical technique recommended in USP 1788 for measuring subvisible particles. FIM provides accurate particle concentration and size measurements as well as morphology data which indicates particle type. We will discuss how FIM instruments can help researchers align with USP guidance for monitoring subvisible particles. We will also discuss how this technique can be used to characterize visible particles to support visual inspection processes.
Learning Objectives:
- Learn about flow imaging microscopy (FIM) and the information it provides about particulate matter in biotherapeutics
- Describe the role of FIM instruments in meeting USP requirements and recommendations on monitoring subvisible particles
- Understand how FIM data can support visual inspection processes for controlling visible particles
Who should watch this webinar?
This webinar will be relevant for researchers working with biotherapeutics and interested in learning about the importance of particle monitoring strategies like flow imaging microscopy.
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