The alliance will address the technical challenges of large-scale, high-efficiency purification of therapeutic exosomes for non-viral drug delivery.
The collaboration seeks to utilize the synergy between BIA Separations Convective Interaction Media (CIM) monolith chromatography columns and Exopharm’s patented LEAP ligands to address the technical limitations that currently hold back large-scale and high-efficiency exosome purification.
Production challenges
BIA and Exopharm said they recognize the demand for a large-scale, high-efficiency purification technology that overcomes critical issues associated with the production of clinical-quality exosomes as delivery vehicles for gene-based therapeutics.
Purification of exosomes has held back their adoption in that respect.
Overcoming such challenges will position exosomes at the forefront of non-viral drug delivery chassis for genetic medicines, such as mRNA therapies, said the partners.
Exosomes are said to several advantages over current non-viral delivery methods, such as nanoparticle technologies – being completely non-toxic, providing efficient delivery of RNA cargoes and doing so without eliciting immune responses within the human body.
Dr Aleš Strancar, co-founder and managing director of BIA, said its CIM monolith technology and Exopharm’s exosome-specific LEAP ligands can work synergistically together to enhance specificity, efficiency, and capacity of industrial exosome purification processes. “This work with Exopharm has the potential to be a game-changer in the emerging exosome field.”
Testing phase
Dr Ian Dixon, founder and CEO of Exopharm, said BIA’s CIM columns are ideally suited as the carrier of Exopharm’s LEAP ligands as they are already used in the industry for large-scale and efficient bioprocessing. “The combination of LEAP ligands, together with CIM monolithic columns, for large scale exosome purification will be tested over the next few months.”
BIA and Exopharm said they expect to have the results from that testing program early next years, after which plans could potentially be made for commercialization.
Growth forecast
Exosomes are an alternative means of drug-delivery inside the body, alongside technologies such as lipid nanoparticles (LNP), cell-penetrating peptides, viral vectors and liposomes.
They are extracellular vesicles excreted by cells into the surrounding fluids that serve as a form of cell-to-cell communication. Cells can exchange metabolites, genetic information, and proteins through exosomes.
RNA can be loaded into exosomes to make therapeutic products that could one-day address many medical problems. Genetic medicines, such as mRNA, require a drug-delivery chassis, and exosomes are emerging as an effective, non-viral chassis for additive gene therapy, CRISPR gene editing, etc.
It is a category is expected to grow significantly in the next decade, according to contract development and manufacturing organization (CDMO) Lonza, which has been investing in developing exosome manufacturing and characterization technologies for the past few years, and, in November 2021, ramped up its focus on that category by acquiring two sites.
The Swiss company bought out Codiak Bioscience’s exosome manufacturing site in the US and Exosomics’ service unit in Italy.
