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.
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.
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.
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.
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
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
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