There is a growing appreciation that the biggest hurdle toward realizing the full clinical potential of human gene therapy and genome editing is delivery. Therefore, quality control in manufacturing and commercialization are vital considerations in developing safe and effective viral vectors and lipid nanoparticles (LNPs). Additionally, identifying potential drug quality issues as early as possible in late phase discovery further ensures the commercialization of safe and effective drugs
In this GEN Biotechnology webinar, Dr. Bernardo Cordovez, Founder and Chief Science Officer at Halo Labs will discuss the challenges of realizing the promise of gene therapies without using large quantities of viral vector or LNP samples during the development process. In particular, he will discuss how the Aura® GT instrument revolutionizes gene therapy formulation development by enabling ultra low-volume characterization of the most important formulation stability critical quality attribute: subvisible-scale biologic aggregate formation. Additionally, Dr. Cordovez will discuss the underlying characterization technology, focusing on aggregate formation, the impact of nucleic acid leakage on viral vector formulation stability, and how this technology can be applied from early development through product release.