Exopharm and EU bioprocessing leader Sartorius BIA Separation are about to go all-in on large-scale exosome production

Exopharm is joining forces with a global bioprocessing leader – and Slovenia’s best performing company – with an eye on changing the game in the exciting, emerging field of exosomes.

Australian biopharma Exopharm (ASX:EX1) will supply its Ligand-based Exosome Affinity Purification (LEAP) to Sartorius subsidiary Sartorius BIA Separations’ (BIA) Convective Interaction Media (CIM) monolith chromatography to enable testing of LEAP-CIM for improved large scale exosome production and commercialisation.

BIA is part of the international life science group Sartorius, a global leader in bioprocessing with 15,000 employees, over US$3 billion in 2021 sales and over 60 manufacturing and sales sites worldwide.

Ranked by Slovenian media as the best performing company in the country after a huge FY22 of lifting revenue by circa 160%, and tripling profits, Sartorius BIA Separations provides biomanufacturing leaders its speciality bioprocessing purification columns, supporting the pharmaceutical and biotech sectors globally.

EX1 has become a leader in advancing Genetic Medicines and other exosome-based medicines using exosomes or extracellular vesicles (EVs) as a chassis for non-viral drug-delivery.

Exopharm has a suite of exosome-related technologies including its LEAP exosome purification technology.

Exosomes are nano-sized particles produced by cells to exchange materials and genetic instructions and coordinate cellular activities in our bodies.

For some medicines, exosomes are an alternative and superior means for delivery inside the body.

Solving exosome production challenges

Together Sartorius BIA Separation and EX1 recognise a growing demand for a large-scale high-efficiency purification technology to enable purified exosomes to solve the drug-delivery problems facing the use of mRNA as therapeutic products.

The monolithic columns are potentially an ideal carrier for EX1’s LEAP ligands that gently ‘pull out’ exosomes from the input material.

CIM monoliths enable high throughput, high capacity, outstanding resolution and would offer high stability along with controlled exposure of the bioprocess material to the LEAP ligands – potentially a synergistic and powerful combination for exosome purification.

As part of the material transfer agreement and associated collaborative program over the next few months the two companies will test the addition of LEAP ligand chemistry to the existing BIA CIM monolithic columns.

The expectation is that the addition of LEAP ligands to the CIM will improve specificity and purity of the purified exosome product over standard BIA CIM ion exchange columns.

Sartorius BIA Separation will also test different immobilisation densities of the LEAP ligands to seek an optimal density for improved performance and efficiency.

Game-changer in emerging exosome field

Leading the company for almost a quarter century, Sartorius BIA Separation co-founder and managing director Dr Ales Strancar, says his team sees the massive potential in exosomes and understands that the challenge of purifying exosomes has held back their broad adoption as a non-viral drug-delivery technology.

“CIM can potentially be improved if we add Exopharm’s exosome-specific ligands on the CIM,” he said.

“This work with Exopharm has the potential to be a game-changer in the emerging exosome field.’

EX1 founder and CEO Dr Ian Dixon said BIA’s CIM columns are ideally suited as the carrier of the 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 will be tested over the next few months,” he said.

“After that, we can potentially explore how to commercialise this advance.”

Genetic Medicines such as mRNA require a drug-delivery chassis, and exosomes are an emerging ideal non-viral chassis for additive gene therapy, CRISPR gene editing and so much more.

RNA can be loaded into exosomes to make therapeutic products that could one-day address many medical problems.

Sartorius BIA Separation and EX1 expect to have the results from this testing program in the first half of CY23, after which plans could potentially be made for commercialisation.

It’s been a week of big news for EX1 which announced it will start technology transfer of LEAP to Astellas Institute for Regenerative Medicine (AIRM) under an ongoing joint master collaborative services agreement (MSA).

This article was developed in collaboration with Exopharm, a Stockhead advertiser at the time of publishing.

This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.