A panel at last week’s Cell Therapy Manufacturing & Gene Therapy Congress in Brussels, Belgium, placed some of the major genetically modified T Cell manufacturers together to discuss the current state of a sector which Chairperson Anthony Davies from Dark Horse Consulting said hardly existed two years ago.
Increasing efficiency and scaling-up production were presented as future challenges but the security of the supply chain was deemed the major risk for developers of Chimeric Antigen Receptor (CAR) T Cell products – immunotherapies which involve the reprogramming of a patient’s own T Cells to recognise and target cancer cells.
“In these difficult processes, security of supply is the major thing and we are all concerned about that,” Lothar Germeroth, Managing Director of Juno Therapeutics, told the delegates. “Sometimes you can only get certain starting materials from very small companies as they are the only ones which manufacture them… they could go bankrupt and out of business.”
Therefore Juno mitigates such risks by developing its own processes, such as its proprietary bispecific CAR technology, while concurrently buying companies and complementary systems such as last month’s $125m acquisition of AbVitro, adding high-throughput full length antibody sequencing technologies to its arsenal.
“Having your own key technologies which you can rely on, which you have the IP on means nobody can interfere with the supply situation,” Germeroth said.
Tech development and licensing
Sylvain Arnauld, Head of Manufacturing at rival company Cellectis, agreed adding in his firm’s experience to developing its own IP was “more efficient” than relying on third parties.
Cellectis uses its own nuclease-based gene-editing technology to develop immunotherapies using CAR T-cells from healthy donors, rather than the patients themselves (allogeneic), and licenses the tech to others, including Thermo Fisher.
Cellectis is also in partnership with Pfizer which owns a 10% stake in the French firm, while other Big Pharma firms Novartis and AstraZeneca have begun investing in gene-editing technology.
Vulnerability
But while the large companies can invest in gene-editing technologies and bioprocessing equipment, smaller players in the sector remain vulnerable, said Jim Faulkner, Head of Manufacturing at one such firm, Autolus – a UK-based CAR T-cell product formed in January 2015.
“Without coming across too envious, there’s a lot of firepower in some of the [bigger] US and EU companies, but at Autolus we can’t afford that luxury and can’t go out and just acquire technologies,” he said.
“At this stage we are over-reliant on suppliers and on particular technologies which we are outsourcing and it makes us feel vulnerable, no doubt, as we grow there is a desire to be more in control of the supply chain as I do worry that things can happen that are outside of our control.”