710. Surface Adsorptive Loss of rAAV on Materials Used in cGMP Manufacturing

Continued interest in using rAAV vectors as therapies for a range of indications with varying prevalence often translates to increased manufacturing scales. A significant challenge that is encountered is the use of different manufacturing materials during the transition between early research and development and the clinical manufacturing scale. For example, manufacturing components, ranging from bioprocessing bags and hard plastics to bioprocess tubing and filters can be constructed of different materials and are not often engineered for use with rAAV. In this work we investigate the loss of rAAV to non-specific surface adsorption on various materials of construction. In addition, the effect of different background matrices was also investigated. These data demonstrate that surface adsorptive loss of rAAV can be significant, and that losses can vary significantly even for materials of similar construction. To mitigate adsorptive loss, several surfactants and other components were examined for their ability to reduce surface adsorption of rAAV. A number of these agents were identified as viable options for cGMP manufacturing. These results provide insight for the development of scaleable, more robust and higher yielding manufacturing processes to meet the continued demand for rAAV therapeutics.