Sartorius BIA Separations (BIA) and Exopharm Ltd. have signed a Material Transfer Agreement and associated collaborative program that 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.
BIA 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 utilize novel and innovative technologies alongside subject matter expertise provided by both Companies.
As part of the program, BIA’s CIM monolith chromatography columns have been selected as an optimal 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. Selected 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.
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. 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. Immune and cytotoxic responses to lipid nanoparticle-encapsulated mRNA have been a major concern in early clinical studies1. Furthermore, exosomes can be engineered to provide specific delivery as well as repeated dosing.
Initial research efforts between BIA 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 also aims to determine the optimal immobilization density of LEAP ligands for high-throughput, large scale production of purified exosomes.
BIA and Exopharm expect to have the results from this testing program early in CY ’23, after which plans could potentially be made for commercialization.
Exopharm’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.
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