Industrialization of exosome manufacturing
Developing a high-performance exosome manufacturing process has been a strategic priority for Codiak since the company’s inception. From the outset, we quickly realized that traditional methods did not provide the industrialized, commercially scalable, highly efficient and reproducible manufacturing process that would be essential for this new class of biotherapeutics– so we built it from the ground up.
Our proprietary manufacturing and analytical technologies are pillars of our engEx™ Platform that we believe will make it possible for us to rapidly turn our engineered exosomes into potent therapeutic candidates with the quality and quantities needed to serve broad patient populations.
The Process
Our proprietary manufacturing process is designed to efficiently and reliably produce our exosome therapeutic constructs for multiple clinical targets and/or indications:
Molecular Engineering
Exosomes are engineered utilizing our proprietary scaffold proteins.
Exogenous Drug Loading
If necessary, exosomes are loaded exogenously with a specific therapeutic payload here.
Master Cell Banks (MCBs)
Engineered human cell lines that are fully characterized and GMP released.
Production Bioreactor
The cells are cultured at large scale in suspension to produce exosomes, using either fed-batch or continuous (perfusion) technology. We have employed either 2,000L fed-batch and 500L perfusion bioreactors. Codiak’s novel perfusion technology makes it possible to generate the large volume of exosomes needed for large patient populations.
Purification
Exosomes are separated from various types of impurities generated in the bioreactor, yielding product of unparalleled purity and quality. Our propriety process is based on advanced chromatography and filtration technology as opposed to the centrifuge-based technology that has been traditionally employed in the field. We estimate that with a single Codiak GMP production run, we can produce an equivalent amount of purified exosomes that would have traditionally required >2000 centrifuge runs.
Drug Product
Formulation of the purified exosomes in stability-enhancing buffer, followed by filling in vials.
Unparalleled Infrastructure
Solving the challenges of bringing a new therapeutic modality to patients requires consistent diligence and ongoing innovation. We believe our process development team is one of the best in the industry, keeping us at the forefront of this new field. We continue to refine our manufacturing process and innovate on new methods to push the boundaries on what is possible.
We also built a new clinical manufacturing facility. This facility will enable us to rapidly produce our drug candidates for early phase clinical trials.
