Exosomes – Industry News

Exosomes continue to make news and build momentum in the pharmaceutical industry. On Tuesday this week Swiss based Lonza Group AG (SWX: LONN, market capitalisation USD 57.7B) announced that it was acquiring Codiak’s Manufacturing Facility in Lexington Massachusetts (USA) and taking on the role of the exclusive manufacturing partner for Codiak’s pipeline of exosome pharmaceutical products. This move by Lonza validates and derisks the future importance of exosome medicines and the commercial potential Lonza sees in the pharmaceutical field as exosomes become a key delivery means for new medicines including gene therapy.

Founded in 1897 and operating over 5 continents and with 15,000 employees, Lonza is a leading Contract Manufacturing Organisation (CMO) – Lonza’s web site says ‘In 2020 we supported more than 820 preclinical and clinical small and large molecules, more than 245 commercial small and large molecules and produced 230 billion capsules.’

Codiak (NASDAQ: CDAK) is a US based exosome medicines company, formed in 2015, with a market capitalisation of around USD350m.

Under the announced agreement, Lonza and Codiak have agreed to establish a Center of Excellence focused on exosome manufacturing and exosome analytics – and Codiak will receive approximately USD65 million of manufacturing services for its clinical-stage exosome programs at no cost.

This agreement highlights the importance and financial value of intellectual property and know-how in exosome manufacturing. Other CMOs are now likely to follow Lonza’s initiative. Exopharm is also in discussions with other CMOs about licensing and partnering opportunities.

The announcement describes Codiak’s perfusion-based cGMP process for exosome manufacturing.

Exopharm Limited (ASX: EX1) is a leader in exosome purification technology and has proprietary technology and know-how that supports large-scale purification of exosomes. Recently Exopharm signed a Feasibility Study agreement with Showa Denko, another international CMO and biomanufacturing innovator. Exopharm has also recently announced that the United States Patent and Trademark Office (USPTO) is set to grant the first of Exopharm’s LEAP patents covering the use of affinity chromatography to purify exosomes in large scale. The Russian patent for LEAP has already been granted.

Like Evox and Exopharm, Codiak currently uses a number of steps to produce exosomes. Codiak highlighted their use of a perfusion system to culture the cells that produce exosomes and ‘clarify’ what the cells produce. Perfusion systems are standard equipment in biomanufacturing. Lonza may still need to purify their exosomes after this perfusion step. Recent publications from Codiak point to further purification steps using chromatography equipment.

Linked below is a paper written by Whitford and Guterstam which explains the status of exosome manufacturing in 2019.

Whilst Codiak claims a cGMP (Good Manufacturing Practice) capability, it is not clear that they have a proprietary or patentable process.

Also provided below is a link to an article on Contract Pharma about the agreement between Lonza and Codiak. If you have any questions about this news, please feel free to contact us at any time.

Contract Pharma Articla Exosome manufacturing status - Whitford and Guterstam

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