"Nick And the Cocoons": Automation for Autologous Therapies
By Louis Garguilo, Chief Editor, Outsourced Pharma
We’ve dispensed somber analysis on a lack of assistance from established CDMOs for emerging cell and gene therapy developers.
The critique emanates from executives at these biopharma companies, particularly those pursuing autologous-cell or other personalized- or precision-medicine approaches. There’s a discernable lack of suitable capacity and development services, if not an overall business model for working with these potential CDMO clients.
Yet, in the middle of this despondency, we’re beginning to encounter some bright spots.
It is, in fact, time to give the other side – those CDMOs taking the incoming criticism of big-customer and big-project bias – a chance to respond.
That materialized in a frank conversation with Nicholas Ostrout, Senior Director, Commercial Development - Personalized Medicine, at Lonza. Ostrout calmly and graciously fielded my pointed questions and shared his view of the good news.
Matching Visions
In 2014, he joined Miltenyi Biotec, where he did application and market development. He moved to Lonza when he discovered the company was establishing a business unit based on “some amazing technology and automation” – the self-contained system for cell generation called the Cocoon.
“We shared a strategic vision,” says Ostrout. “This piece of cell-manufacturing equipment could play a huge role in moving autologous-cell therapies forward. It can drive down manufacturing costs, and help these therapies become accessible to a greater number of patients.”
Originally, Lonza intended to keep the Cocoon within, as a value proposition for manufacturing there. But the leadership had other ideas: get more people to use this “revolutionary technology,” and it would also turn out well for us,” explains Ostrout.
“We have a long reputation for manufacturing, but as you suggest, it’s no secret we come at a price. Many of these emerging companies can’t spend a significant amount of money just to get phase 1 data, or try to establish if the therapy is safe and efficacious.
“So we're seeing more companies use organizations like Dana Farber, universities like Stanford, and smaller service-provider centers like C3i Center to generate initial clinical data”
In other words, cell-therapy developers are looking for less expensive options (particularly for phase 1 trials), and flexibility for support, perhaps what they are not finding from traditional CDMOs.
Get What You Pay For
At Lonza, a flexible sales model was needed to serve the small-customer cohort pursuing autologous-cell therapies. The product was commercially launched in 2020, and, says Ostrout,
“anybody can buy a Cocoon.”
But that depends. On cost, foremost.
Ostrout shares that since Cocoons are scalable, multiple purchases bring a level of negotiation. “If, for example, Novartis wants 100, of course we’d talk about price – and services.”
That flexibility in pricing and otherwise doesn’t seem to reach the ears of the smaller biopharma execs out there. The only thing most small biotech execs think of when they think of Lonza is “$$$$”.
“It's a shame to hear that, honestly,” says Ostrout. “Our CGT, BioScience and Personalized Medicine business units work closely together. Our new commercial manufacturing operations are becoming more flexible. Hopefully, we can change that mentality from these emerging biopharma execs.”
The Cocoon itself, he points out, offers a new level of automation, allowing for great flexibility, and lower costs.
“If anything, Ostrout says, “COVID has amplified the fact that we need automation more than ever. And any new technology has to be proven by the market.”
A market, he concedes, that’s still unclear.
“Maybe these therapies will be manufactured at point-of-care, a decentralized health network, or at large pharmaceutical or CDMO manufacturing facilities. We don't know. We won’t say it's only going to be manufactured here at Lonza, or at other CDMOs. We want to see where it goes organically and ensure we're a part of that outcome.”
At this point, I suggest (again) to Ostrout few I’ve talked to equate Lonza with personalized medicine. The CDMO is just too big, and too busy with bigger projects and customers. And again, there’s always a concern with price.
Still, what we are learning is this CDMO – and I believe this is indicative of other established CDMOs leaning into this market – Lonza spent the energy to acquire a company that originated this technology (Octane Biotech), and further develop the Cocoon with at least one eye on the emerging companies out there.
“But why even bother with personalized medicine? Can you really make money here?” I ask.
“Autologous-cell therapies have shown huge promise,” Ostrout answers. “Potentially, it's a multi-billion-dollar industry. We want to stay at the forefront of manufacturing technology, whether it's allogeneic, autologous, regenerative medicine – we are always looking for creative, cutting-edge ways to manufacture less expensively. We have to innovate to stay competitive.”
He takes a breath, and continues:
“I really see that there's a long-term market for autologous-cell therapies. The field, in general, may argue with that. A lot of people say, ‘No allogeneic will kill autologous; it's just a matter of time.’ But who knows? I think there’ll always be a place for autologous. Even if we build an allogeneic product, it might serve as a chassis we can personalize for the individual patient – of course using the Cocoon.
“It’s a business opportunity. We saw an opportunity here to bring interesting technology into Lonza, and into this brand-new, exciting field. Opportunities like the one with C3i and Triumvira help validate that model.
“The future depends on what decentralized manufacturing means to you. Is it within the hospital, which is what CellPoint thinks, or regional hubs? Is it what C3i thinks it means to them as a CDMO? Or maybe it will be established Cocoon centers as we have at our site in Houston.
We're playing in all sandboxes because it's such a new field and everyone has a different opinion. We’ve set up to at least make the technology available – sale, , or for-a-service with us – and plug it into the entire industry.”
And that industry has a growing base of emerging developers starved for assistance. Will they get it from some of the biggest CDMOs in the world?
Time will tell, but it does look like the times are changing.