Datum der Aufzeichnung: 18 May 2020
Ever-more structurally complex bio-molecules and biological entities are coming into focus within the pharma development space warranting growing requirements for fit-for-purpose analytics and extendeding characterization through orthogonal use of multiple technologies.
Viruses have long been used in vaccine development as delivery vehicles or attenuated and inactivated vaccines. They are also increasingly used as vectors in gene therapy. Recombinant Adeno-Associated Viruses (rAAV) are a class of viral vector that is being investigated intensively in the development of gene therapies. In order to develop efficient rAAV therapies produced through controlled and economical manufacturing processes, multiple challenges need to be addressed starting from capsid design through identification of optimal process and formulation conditions to comprehensive quality control of Drug Substance and Drug Product.
Addressing these challenges require extensive characterization of rAAV samples with multiple assays including measurements of capsid count, % full rAAV particles, particle size, aggregate formation, stability, genome release and capsid charge.
In this webinar, Natalia Markova and John Stenson of Malvern Panalytical will present on how Dynamic Light Scattering, Differential Scanning Calorimetry and multi-detection SEC (SEC-MALS) can be used as orthogonal and complementary technologies for enhanced characterization and generation of multi-parametral stability profile of rAAV samples.