Downstream Process Intensification for AAV Purification by Affinity Chromatography Using Single Pass Tangential Flow Filtration.

ABSTRACT: To enable adeno-associated viral vectors (AAV) to achieve their maximum potential, next-generation manufacturing processes must be developed to make gene therapies more affordable and accessible. This study focused on the design of two different intensified AAV downstream manufacturing processes at bench and pilot scale. Novel clarification methods were studied at bench scale, including the use of BioOptimal™ MF-SL tangential flow microfilters for continuous removal of cell debris. Membrane adsorbers were used for further clarification, including DNA removal. Single pass tangential flow filtration (SPTFF) was implemented at bench scale by feeding the clarified cell lysate (CCL) into two Pellicon XL50 cassettes with 100 kDa regenerated cellulose membranes. At pilot scale, a multi-membrane s

SUBMITTER: Chaubal AS 

PROVIDER: S-EPMC12699131 | biostudies-literature | 2026 Jan

REPOSITORIES: biostudies-literature