Removal of impurities generated in the production of adeno associated virus (AAV) is an important step as they may pose a serious health risk, as well as deteriorate the economics of the production process. The most critical subsets of these impurities include: host cell nucleic acids, host cell proteins, chromatin, capsid aggregates, capsid DNA complexes and empty capsids.
This poster introduces two new column s for performing separation of empty (E) and full (F) capsids using multimodal approach. A PATfix system with three different detectors, i. e. absorbance, fluorescence, and light scattering in combination with three analytical columns traded as CIMac AAV Empty/Full, CIMac PrimaS (AAV) – Beta, and CIMac PrimaT – Beta by Sartorius BIA Separations. The separation columns were used to determine and evaluate empty AAV capsids as one of the critical impurities in AAV samples. The analytical results using CIMac PrimaS (AAV)-Beta and CIMac Prima T- Beta show that other fast and reliable orthogonal HPLC methods to the CIMac AAV full/empty column can also be used for the separation of empty and full capsids with monolithic columns.
