A critical objective in the purification of bionanoparticles is to decrease the amount of residual DNA derived from the producer cell line. A novel strategy was developed for the removal of DNA during the purification of exosomes, an enveloped bionanoparticle. Historical manufacturing campaigns at Codiak have relied upon treatment of cell culture with endonuclease, the gold standard approach employed in viral vector purification. This approach is a costly one and adds complexity and risk to manufacturing. To reduce the significant cost and resources involved in this operation, an initiative was launched to create a replacement for this step. Through high throughput screening of chemical excipients and nucleases, a novel strategy was developed to remove residual DNA.<br/><br/>When compared to the control process, the novel DNA control strategy demonstrated improved manufacturability, and comparable residual DNA content, yield, and exosome quality attributes. Implementation of the new control strategy also eliminates a pre-capture batch incubation step, creating opportunities for future integrated continuous processing to further improve manufacturing productivity.

Next-gen DNA control strategy for engineered exosomes

ACS Spring 2022

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