A View On Exosome Manufacturing

Putting Manufacturing First: Codiak Moves Swiftly into Clinical Trials with Exosome-based Treatments Sriram Sathyanarayanan, Codiak’s CSO, and Linda Bain, their CFO, share how the company moved into clinical trials in under 6 years. Exosomes, extremely small vesicles shed by all cell types, promise to become a viable delivery system for treatments of many diseases. But until recently, manufacturing them at a commercially viable scale has been unfeasible. That is why in 2015 the company Codiak took a two-pronged approach to developing exosome-based treatments: prioritizing both the engineering and manufacturing tracks from the outset. A mere six years after the company was launched, this approach has proven effective, with two promising studies in the clinic for tumor treatments, while most other developers are still at the starting blocks. The exosome field today holds the kind of promise that antibody and protein-based therapeutics did in the 1980s—the potential to improve both treatments and patient well-being is great. With a low risk of immunotoxicity, leveraging their natural abilities and engineering them to deliver targeted therapies could open new therapeutic pathways to previously undruggable targets. Yet as recently as only a couple of years ago, manufacturing exosomes was limited to small batches. Codiak has successfully increased production to thousand-liter batches, permitting clinical studies and greatly improving the prospective of widespread use. In collaboration with Lonza, Codiak is doubling down on their advantage with a recently established Center of Excellence for exosome manufacturing in Massachusetts. To learn more about Codiak’s pipeline of therapeutic candidates with a potential to transform patients’ lives, visit: https://www.codiakbio.com/pipeline-pr... Curious to Know More? Listen to Martina Hestericová’s conversation with Sriram Sathyanarayanan and Linda Bain as they discuss the advantages of exosome treatments, how they are developed and why the company’s early manufacturing strategy is paying off. KEY TERMS IN CONTEXT: Exosomes are nano-sized delivery vehicles generated by all eukaryotic cells. They are roughly between 30 and 120 nanometers large and originate when endosomes, or intercellular vesicles, are released into the blood, milk or tissue. Exosomes then become messengers and surrogates for the original cell. Their surface markers represent a location code and spread through the extracellular space in the body to communicate with other cells and deliver packages. Commercial exosome manufacturing is the scaling-up process of moving from small-batch exosome production that uses ultracentrifuges to large-scale production that in many ways resembles the processes already used to manufacture antibody and protein-based therapies. The exosome’s lumen is the interior volume of the exosome where, through biological engineering, the therapeutic molecule can be placed. The molecule can also be on the surface of the exosome, allowing for two alternative payload capacities, depending on the target. Immunosafety and immunotoxicity refer to how potentially safe or toxic the immune system’s reaction to a molecule may be. Since exosomes already have a history of low immunotoxicity – think of blood transfers – their immunosafety is already proven to be very high.