Slovenian-based Sartorius BIA Separations (BIA), a bio-chromatography company, and Australia's Exopharm Ltd., a company working with transformative medicines using exosomes, or extracellular vesicles (EVs), have entered into a formal collaboration.\n\n\n\nA material transfer agreement has been signed by both companies and an associated collaborative program has been implemented which aims to exploit the synergy of Exopharm’s patented LEAP technology together with BIA’s unique CIM (convective interaction media) monolith chromatography for improved large-scale therapeutic exosome production and commercialization.\n\n\n\nBIA Separations and Exopharm 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. To meet this demand, the new collaboration will use technologies with subject matter expertise from both companies.\n\n\n\nAs part of the program, BIA’s CIM monolith chromatography columns have been selected as the best carrier for Exopharm’s LEAP ligands. BIA’s CIM monolith chromatography columns enable high-throughput, capacity and resolution separation in combination with high stability and controlled exposure of the bioprocess material. \n\n\n\nExopharm's LEAP ligands\n\n\n\nSelected to work synergistically, Exopharm’s LEAP ligands are able to ‘gently pull out’ exosomes with a high degree of efficiency and could provide a powerful solution for large-scale and high-efficiency purification of therapeutic exosomes.\n\n\n\nGenetic 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. RNA can be loaded into exosomes to make therapeutic products that could one-day address many medical problems. Exosomes have advantages over alternative nanoparticle delivery technologies – being non-toxic, efficient at delivering RNA cargoes into cells and able to do so without eliciting an immune response. \n\n\n\nImmune and cytotoxic responses to lipid nanoparticle-encapsulated mRNA have been a major concern in early clinical studies, the companies discovered in their research. Furthermore, exosomes can be engineered to provide specific delivery as well as repeated dosing.\n\n\n\nInitial research efforts between BIA Separations and Exopharm will focus on the assessment and validation of the addition of LEAP ligand chemistry to CIM monolithic columns, with the expectation that this will improve both specificity and purified exosome purity relative to BIA CIM ion exchange columns. In addition, BIA Separations also aims to determine the optimal immobilization density of LEAP ligands for high-throughput, large scale production of purified exosomes.\n\n\n\n Research efforts between BIA Separations and Exopharm\n\n\n\nBIA Separations and Exopharm expect to have the results from this testing program early in CY ’23, after which plans could potentially be made for commercialization.\n\n\n\nAleš Strancar, co-founder and managing director of BIA Separations, said: “BIA sees the potential in exosomes for new and innovative therapeutic applications and understands that purification of exosomes has held back their adoption as a non-viral drug-delivery technology. We believe that BIA’s 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.”\n\n\n\nIan Dixon, founder and CEO of Exopharm, added: “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, after which we can begin to explore how best to bring this exciting new technology into applications.”\n\n\n\nExopharm’s LEAP technology is subject to US Patent 11,202,805 B2 and its utility for purifying exosomes has already been demonstrated when the LEAP ligand chemistry is immobilized on other substrates (resins) in affinity chromatography columns.