ROBUST AND SCALABLE MANUFACTURING UTILIZING 3D CUSTOM PERFUSED FIXED-BED BIOREACTORS

EXO-HARVEST — SCALABLE COST-EFFECTIVE MANUFACTURING

To unlock the full potential of exosomes, it’s essential that they are affordable and readily available. Exo-Harvest delivers both by providing a cost-effective and scalable method for high-yield, large-scale exosome production, based on these core features:

  • Featuring different 3D scaffold geometries, Exo-Harvest is a departure from the standard fixed-bed reactors that rely on spherical particles to maximize surface area. By optimizing the flow, the unique scaffold architecture maximizes the process yield.
  • Driven by microfluidics, the platform offers precise control over media and oxygen flow for optimal product development.
  • By providing a closed automated system, manual intervention is minimized. This ensures a robust process with a minimal risk of batch-to-batch failure.

COST-EFFECTIVE PROCESS OPTIMIZATION

Exo-Harvest’s high-throughput mini-bioreactor can test 24 conditions in parallel on a small volume, drastically reducing development time and batch costs.

While cell expansion at this scale is typically done in a 2D format, Exo-Harvest enables the use of the 3D scaffold during optimization, resulting in unique benefits:

  • The performance of different geometries can be compared, in addition to traditional parameters like media composition, leading to higher yields. An AI tool selects the best geometry using the process data and microfluidic simulations.
  • Transferring the optimal process conditions to larger reaction volumes becomes much more predictable, facilitating scale up. It also allows the cost per dose of each condition to be extrapolated to a large scale GMP process, using another digital tool. The opportunity to consider cost at the early stages of development ensures the most affordable product.

A SCALABLE PLATFORM

Exo-Harvest accommodates all maturity stages of a product. In addition to cell expansion and exosome production at small volumes in the high-throughput bioreactor, a mid-scale (0.5 m2) and large clinical lot scale reactor (50 m2) are under development for automated cGMP manufacturing.

Would you like to learn more about our platform, or are you interested in collaborating? Get in touch!