Biopharma

FlowCam for AAV Aggregation Detection in Gene Therapies 

Assess the stability and quality of the next generation of biotherapeutics designed to treat cancer, immunize against pathogens, and address genetic disorders. 

Flow imaging microscopy detects aggregation of viral vectors such as AAVs, lentiviruses, and retroviruses as well as non-viral therapies like LNPs and exosomes.

Use FlowCam to:

  • Monitor viral and nonviral vector aggregation in gene therapy formulations and drug products during formulation and process design
  • Distinguish between inherent vector aggregates, intrinsic particles like glass flakes, and extrinsic contaminants
  • Obtain reliable particle size and concentration measurements recommended by USP <1788> to support quality control processes
  • Characterize particles as small as 300 nm with industry-leading image quality

Helpful Resources

Advancing Subvisible Particle Analysis
Ebook
Advancing Subvisible Particle Analysis
Monitoring Subvisible Particles in AAV Therapies with Flow Imaging Microscopy
Application Note
Monitoring Subvisible Particles in AAV Therapies with Flow Imaging Microscopy
“With FlowCam we get to see the particle morphology instead of just counts, and that really helps facilitate the debugging process if we encounter any issues during the development of new products.”
David Rhodes, Formulation and Analytical Group Protein Sciences Corporation, a Sanofi Company

Read the case study

FlowCam collage of AAV aggregates
A FlowCam collage of AAV aggregates generated under various stress conditions
lentivirus aggregates

Sample FlowCam images of lentivirus aggregates

A FlowCam collage of particles in a heat-stressed LNP formulation

A FlowCam collage of particles in a heat-stressed LNP formulation

Formulation Development of Viral and Non-Viral Vectors 

Like other parenteral biotherapeutics, injectables in gene therapy are subject to regulations like USP <788> that require particle testing to mitigate safety risks.

Flow imaging microscopy techniques allow for the identification and characterization of particle types in your formulation, enabling you to make formulation and process improvements during product development. 

  • Meet USP requirements and recommendations with FlowCam LO—a combined flow imaging and light obscuration instrument 
  • Detect gene vector aggregates such as LNP oligomers as small as 300 nm with FlowCam Nano

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