Industrial-scale manufacture of therapeutic exosomes

Coordinated purification process development service accelerates progress to clinical trials, and scale-up manufacturing.

Introducing two proprietary new technologies central to highly pure and scalable purification, BIA Separations’ Exosome Process Development Solution represents the latest extension of its CORNERSTONE programs for the manufacture of gene therapy vectors, following the launch of its AAV program earlier this month.

Exosomes fulfil 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 realised, 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 important new tools for this purification, whilst ensuring fast and efficient process development. The technology is easily scalable from lab to manufacturing, and is able to provide better product quality than traditional purification systems.

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. The technologies are available as part of a comprehensive Process Development Service, in which BIA Separations’ experts design and optimize processes to support clinical trials and scale-up to industrial manufacturing. Translational scientists and process developers can also access both new products as a Process Development Pack for exosome research purposes.

Aleš Štrancar, CEO at BIA Separations, said: “Exosomes represent the next generation delivery strategy for nucleic acids and other therapeutics, as well as being evaluated as a platform for regenerative medicine with high hopes of bringing more therapeutic options to chronically ill patients. We are all looking forward to seeing the impact of our tools on this novel therapy space.”

Pete Gagnon, Chief Scientific Officer at BIA Separations, added: “Every new product class presents a unique new set of challenges and exosomes are no exception. Our new CORNERSTONE program embodies the decades of experience we’ve developed with the purification of viruses, DNA plasmids, mRNA, and other gene therapy products, and extends it to include exosomes. This gives our customers a head-start that will help them be first to the clinic and first to market.”