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Industrial Scale Manufacture of Therapeutic Exosomes

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BIA Separations has announced the introduction of its CORNERSTONE Exosome Process Development Solution, designed to help drug-developers overcome critical development bottlenecks in the preparation of exosomes for clinical use.

Exosomes fulfill a critical role as communicators among cells, with targeting and message content depending on their surface receptors and payload. Their unique ability to deliver that payload to the right target makes them obvious candidates for an extensive range of therapeutic applications in the fields of cancer and regenerative medicine, including for neurodegenerative and cardio-pulmonary disorders.

For such clinical applications to be realized, thoroughly purified exosomes are required, with key contaminant classes such as host-cell proteins, host-cell DNA, and non-exosomal vesicles reduced to trace levels. BIA Separations’ new technology brings new tools for this purification, whilst ensuring fast and efficient process development. The technology could be scalable from lab to manufacturing.

CORNERSTONE Exosome Development Solution is built on the capabilities of two novel technologies. Kryptonase™ is an integrated enzymatic treatment that reduces host-cell DNA and facilitates the removal of host-cell protein contaminants. The CIMmultus™ EV monolithic column is a chromatography device that eliminates non-exosomal vesicles, and concentrates exosomes in a low shear environment.