Exosomes are small membrane vesicles that are secreted by a multitude of cell types, which play a role in cell to cell communication. They can serve as clinically valuable tools for early diagnosis, prognosis and potentially targeted treatment.

From a manufacturing stand-point, the challenge resides not only in the production but also in the characterization. Exosomes have the potential to make cell and gene therapies commercially viable for large populations.

We are still at a very early stage and most developers of these innovative technologies are in pre-clinical or early clinical stages, working to demonstrate the efficacy and the potential of exosomes-based therapies. 


Prime biological cargo delivery

Exosomes are produced by all cells. They are a sub-group of extracellular vesicle with a size range typically between 30 and 150 nm, have a Phospholipid Bilayer shell with specific surface markers, and a genetic package containing of RNA, DNA and proteins.
Some cells can use exosomes to transfer genetic material from one to another. Specifically, an exosome can transfer microRNAs to control the expression of a gene, and messenger RNAs to manufacture proteins. They also transfer proteins themselves, lipids, DNA and others.

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Exosomes are acting as cargo delivery systems in our body to deliver specific packages with positive or negative messages from one cell to another in a targeted way at distance. Simply put, they are a fresh and well conserved source of biomarkers coming from live cells which reflect those of the parenteral cells.

 

So what stands in the way?

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Aside from decoding the biology and mechanism for therapeutic effect in this novel field, these are some key challenges faced by exosomes-based therapy developers. Those are linked to the very early and pre-clinical stage which most of the exosomes-based therapies are in. There are limited characterization methods available, a need for precise isolation & purification methods and few partners who can provide access to end-to-end GMP manufacturing expertise. Identifying optimal formulation, obtaining starting cell-lines, media, gene editing & cargo loading can be a challenge, as well as defining functional assays.


No mountain high enough

Choosing the right partner becomes critical in such a pioneering field. By leveraging our knowledge in 2D/3D cell culture and our viral manufacturing expertise, alongside the latest exosome characterization technologies, we can provide a complete path for exosome manufacturing.

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Why partner with us?

  • Leveraging 20+ years experience of cell therapy upstream and viral vector downstream, alongside 100+ iPSC, HEK and MSC customer projects

  • 2+ years of exosome manufacturing expertise, including research and development

  • Exosomes is strategic to our business and we are investing in expanding our capabilities in this area

  • Partnership with Exosomics S.p.A. to enable enhanced characterization technologies

  • Extensive bioprocessing and bioreactor experience for a wide range of applications

  • Development of manufacturing processes using various starting cell types including somatic cells, pluripotent and tissue-specific stem cells

  • End-to-end service offering:

    • Phase appropriate assay and process qualification

    • Full characterization

    • Tissue acquisition and cell line development

    • Upstream, downstream, formulation and fill & finish

    • Supply chain orchestration system through partnerships

    • Lifecycle regulatory support

  • Thought leadership through global, dedicated exosomes projects and collaborations

  • We are open to a variety of collaboration options with exosomes developers


Our global map of exosomes-related activities

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