(547a) Industrializing Exosomes: Turning Research Breakthroughs into Clinical Candidates

Exosomes are vesicles comprising lipids, proteins, carbohydrates, and nucleic acids that are produced by cells. Research illuminating the central role of exosomes in intercellular signaling and nucleic acid delivery has exploded in the last twenty years. In 2015, Codiak BioSciences was founded to convert deepening insights in exosome function into promising new therapies for patients.

Developing a high-performance exosome manufacturing process has been a strategic priority for Codiak since the company’s inception. From the outset, it was clear that traditional exosome isolation methods did not provide the industrialized, commercially scalable, highly efficient, and reproducible manufacturing process that would be essential for this new class of biotherapeutics. Early on, close collaboration between Research and Development was necessary to address fundamental questions such as what defines an exosome, how best to isolate exosomes analytically, and which characterization tools provide the most insight. The most vexing questions often resided at interfaces, requiring an interdisciplinary problem-solving approach that also yielded breakthroughs such as technology to enable exosome engineering. The understanding gained from our early exploratory work was then combined with established best practices, high-throughput process development, and scalable unit operations derived from recombinant proteins to develop our proprietary system for robust and consistent GMP manufacturing at scales, which exceeds the current state-of-the-art for bionanoparticles. With multiple clinical trials underway, our priorities have now shifted to maximizing potency and increasing productivity through conversion of a platform batch production process into a proprietary integrated continuous process.

Growing a company in a new complex area also brings several challenges. There are often more questions than answers and one must enjoy the act of building knowledge, with both its eureka moments and frustrating dead ends. It can be challenging to maintain the appropriate balance between the depth and breadth of a nascent platform. In this talk, I will share some of the highs and lows in the journey of Codiak from a small start-up to a leading clinical-stage exosome company.