Exosomes are vesicles comprising lipids, proteins, carbohydrates, and nucleic acids that are produced by cells. These complex nanoparticles transit the body and are taken up by cells, thereby altering the recipient cell biology. Codiak BioSciences seeks to harness the therapeutic potential of exosomes as a novel modality by loading pharmacological biomolecules into exosomes and through decoration of the exosome surface with recombinant ligands to co-opt the natural trafficking and uptake of exosomes. The common framework and diversity of engineered surfaces that stem from these approaches create both opportunities and challenges in downstream processing.<br/><br/>Widespread adoption of modular purification trains has revolutionized the production of recombinant proteins, leading to benefits including highly efficient development workflows, streamlined scale-up, and reduced COGm. Codiak has created a scalable exosome production platform based on chemically-defined, suspension cell culture with purification using advanced, ultracentrifuge-free downstream unit operations. In this presentation, we describe the purification of several different engineered exosomes in our platform production process. We show that process performance is comparable across exosome constructs. Discussion will highlight how the unique properties of bionanoparticles shape process design choices and highlight areas where adoption of innovative technologies drives process development. The establishment of a modular production process for exosome removes a significant bottleneck in the development of exosomes for therapeutics.

Development of a second generation process for the production of clinical-grade exosomes

2019 Spring National Meeting

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