by Natalie Morrison
LONDON, Sept 5 (APM) - The high cost of CAR-T therapies will begin to fall now the first one has been approved, as the “ripple effect” draws the interest of tool and equipment makers and service providers, experts told APM.
However, the lack of skilled workers who can manufacture these therapies could restrict market potential as more CAR-T treatments reach the market, Martin Lamb, executive vice president of sales and marketing and cell and gene therapy supply chain software company TrakCel, told APM on Friday.
The expert's comments follow last Wednesday's approval of the first CAR-T drug, Novartis’ Kymriah (tisagenlecleucel, formerly CTL019) (APMMA 54476). This came just two days after the announcement of Gilead’s $11.9 billion acquisition of Kite Pharma (APMMA 54431), which will likely have the next approved CAR-T.
Interest in the space has since boomed, they said, noting this can only serve to lower manufacturing costs as different kinds of companies begin to seriously assess entering the sector.
Manufacturing is the biggest cost to tackle, including the cost of reagents, materials and highly skilled labour, said the International Society for Cell Therapy’s (ISCT) Bruce Levine, who is also a professor in cancer gene therapy at the University of Pennsylvania which ran some of Novartis' Kymriah trials.
Novartis's cost of goods for Kymriah is reportedly around $200,000, a relatively high proportion of its $475,000 list price when considering Novartis’ pay-for-success and other access programmes and its reported $1 billion in development costs (APMMA 54486).
Is automation the answer?
As experts previously told APM (APMMA 52464), several of Friday’s interviewees stressed the importance of automating the manufacturing process to bring down costs.“Every day we are making progress on manufacturing process, on automation, on making the manufacturing process a closed system,” said Stephane Boissel, chief executive of French CAR-T regulator therapy (CAR-TReg) developer TxCell.
“A lot of money is being invested by all stakeholders - equipment manufacturers, contract manufacturing organisations, the developer themselves,” he said, noting “I can guarantee the cost of goods is going to go down.”
Kymriah’s authorisation has also grabbed the attention of other fields such as robotics and other automation-aiding technologies which could cut the cost of production, Levine added
As more of these products are approved, more tool and equipment makers will be working to bring new technologies which will lower the manufacturing cost, he said.
Citing his own firm as an example of how quickly the cost of cell therapy manufacturing can come down, Boissel said that by the time TxCell gets its first product approved, its cost of manufacturing should be five or six times lower than its first manufacturing process.
This is over a space of just three to five years, he said.
Low-hanging fruit for automation
Lamb, however, argued that since these drugs are produced on an individual, per-patient basis, it is extremely difficult to automate the manufacturing process.He added that the skilled workers currently being used for Kymriah production and in other CAR-T developers’ manufacturing processes are in short supply, warning that this could become a problem as more products are approved.
He noted that a lot of these skilled workers - especially in the typically smaller companies of the CAR-T sector - have to “wear a lot of hats” when it comes to production, managing not only manufacturing but the supply chain and other aspects.
Lamb said that by automating at least those parts of manufacturing which can be easily automated - namely the supply chain - the few skilled workers would have more time to focus on value-added work like processing. TrakCel, who Lamb works for, is one of the companies offering an IT management system for the cell therapy supply chain.
Kymriah’s approval will likely see more providers like TrakCel popping up, he said, particularly targeting smaller companies developing CAR-T.
TrakCel was in discussions with both Novartis and Kite, though being a big player Novartis decided to develop its own system, and Kite had previous strong working ties with a different provider, which it now works with, Lamb said.
Better-oiled logistics
Bringing down the cost of supply chain logistics - something that will happen as people become more familiar with the process and the chain becomes “more oiled” - could also help, said Miguel Forte, chief commercial officer at the International Society for Cell Therapy (ISCT) and chief medical officer of Belgian cell therapy company Bone Therapeutics.For autologous CAR-T, the supply chain is unusually complex, with cells harvested from patients, frozen and shipped to a processing facility before being sent back for transplantation into patients.
Already there are more providers with offerings ready to handle cell and gene therapies compared to a few years ago, when companies would have to set up these arrangements from scratch, Forte said.
Levine even suggested the idea of delivery to the pharmacy by drone in the future as a way to speed the supply chain and cut costs.
Mark Sawicki, chief operating officer of Novartis and Kite’s cold chain logistics supplier Cryoport, however previously told APM that the cost of logistics for CAR-T therapies is still “overshadowed” by manufacturing (APMMA 54503).
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