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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 key attributes of our process include:
Scalability
Support both large and small patient populations
High Purity
Produce only pure exosome constructs
High Productivity
Across multiple manufacturing scales
Reproducibility
The same result each time
Platform Profile
Support multiple exosome constructs

The Process

Our proprietary manufacturing process is designed to efficiently and reliably produce our exosome therapeutic constructs for multiple clinical targets and/or indications:

Upstream Process

Master Cell Banks (MCBs)
more info Molecular Engineering
Production Bioreactor

Downstream Process

Purification
more info Exogenous Drug Loading

Fill Finish

Drug Product
Analytics

To ensure consistent quality and quantity of the exosomes throughout the manufacturing process, we have developed a suite of analytical methods, which are applied in the production of each batch.

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.