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Cell & Gene Therapy Manufacturing & Commercialization US

Schedule to meet with Catalent at Cell & Gene Therapy Manufacturing & Commercialization US

Date: September 20-23, 2021
Location: Boston Convention and Exhibition Center – Boston, MA




Nagendra Singh

Senior Scientist, Downstream Process Development, Catalent Cell & Gene Therapy



Tuesday, September 21, 2021
Time: 2:50PM – 3:10PM EDT
Session Title:  Evaluation of novel affinity resin with alkali stable ligand for AAV viral vectors
Abstract: Purification of recombinant AAV viral vectors from cell lysates can be considered a technical challenge especially if the economic burden for commercial manufacturing is considered. Currently available affinity resins for AAV9 purification deliver reasonable reduction in Host Cell Protein (HCP) at relevant binding capacities and yields. However, the inability to use efficient CIP solutions may have a strong impact on the cost of the capture step. We will present results from a benchmarking study evaluating a commercially available novel affinity resin for purification of AAV9 capsids. The resin was developed for purification of capsids from clarified and concentrated cell lysates. It is (based on) an alkali stable ligand that enables sanitization using NaOH and extensive cycling. The evaluation of the resin will be based on yield, capacity, HCP reduction and reusability. In addition, a comprehensive review of the analytical results obtained from the perspective of different manufacturing scenarios will be provided, including process economics.