Sartorius BIA Separations, Exopharm team for large-scale exosome production

By The Science Advisory Board staff writers

November 23, 2022 -- Bio-chromatography company Sartorius BIA Separations (BIA) and medicine biopharmaceutical company Exopharm have signed a material transfer agreement. The companies aim to use Exopharm's patented LEAP technology together with BIA's Convective Interaction Media (CIM) monolith chromatography to meet the demand of improved large-scale therapeutic exosome production and commercialization.

Genetic medicines, such as mRNA, require a drug-delivery chassis, and exosomes are emerging as an effective, nonviral chassis for additive gene therapy, CRISPR gene editing, and more. Exosomes have advantages over alternative nanoparticle delivery technologies because they are nontoxic and efficient at delivering RNA cargoes into cells and can do this without eliciting an immune response. Furthermore, exosomes can be engineered to provide specific delivery as well as repeated dosing, according to the companies.

As part of the program, BIA's CIM monolith chromatography columns will be a carrier for Exopharm's LEAP ligands. The columns enable high-throughput, capacity, and resolution separation in combination with high stability and controlled exposure of the bioprocess material. Exopharm's LEAP ligands can then "gently pull out" exosomes with a high degree of efficiency and could provide a solution for large-scale and high-efficiency purification of therapeutic exosomes, the companies said.

During their collaboration, BIA and Exopharm researchers will focus on the assessment and validation of the addition of LEAP ligand chemistry to CIM monolithic columns, which they expect 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'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," Dr. Ian Dixon, CEO of Exopharm, said in a statement.

BIA and Exopharm expect to have the results from this testing program in early 2023.

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