eBook: Light-scattering Techniques to Characterize Therapeutic Gene Vectors

The advent of effective vectors for the delivery of nucleic acids, such as adeno-associated viruses (AAVs), lentiviruses, adenoviruses, and lipid nanoparticles (LNPs), is key to treatments for hitherto untreatable diseases. The success and safety of gene therapy programs depend on reliable analytical methods that may be deployed across all stages of development and production. Because gene vectors are inherently heterogeneous products, they present unique characterization challenges.

Analytical techniques based on light scattering—whether stand-alone or combined with upstream separations—quantify critical quality attributes (CQAs) such as particle size, titer and gene loading. These methods support rapid and robust product development, process optimization and quality control, helping ensure safe and effective gene therapies. This e-book describes how light-scattering and size separation methods can accelerate gene therapy programs throughout development and into the clinic.