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eBook

Advancing Subvisible Particle Analysis: Flow Imaging Microscopy

What’s Inside?

AAPS and Yokogawa Fluid Imaging Technologies have joined together to present a thorough introduction to subvisible particle analysis for biotherapeutics, with a focus on flow imaging microscopy, a groundbreaking technique which continues to revolutionize how we ensure the safety and efficacy of biologic drugs. 

Protein therapies using molecules like peptides and monoclonal antibodies have become well established in the clinic. Gene therapies using vectors like adeno-associated viruses (AAVs), lentiviruses, and lipid nanoparticles (LNPs) have shown promise for treating genetic disorders and other hard-to-treat conditions. Biologics already account for over 50% of new drug approvals—a number likely to increase with each passing year. It is crucial that these therapies are monitored to ensure patient safety.

In this ebook, you will learn about:

  • Limitations of traditional subvisible particle analysis techniques 
  • United States Pharmacopeia guidance on monitoring subvisible particles
  • Subvisible and visible particle monitoring applications

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