SAN DIEGO—Cytiva has launched its Sefia next-generation manufacturing platform, with the goal of helping drug developers and larger healthcare providers accelerate their production of chimeric antigen receptor T (CAR T) cell therapies and other cell-based treatments, at lower cost.
Kite, a Gilead company, partnered with Cytiva to develop Sefia, through a collaboration that combined Cytiva’s R&D and manufacturing expertise with Kite’s experience as the developer of two leading CAR T therapies, Yescarta® (axicabtagene ciloleucel) and Tecartus® (brexucabtagene autoleucel).
“We’ve learned a lot during this year and accumulated the experience of thousands of patients that had been treated thanks to our platform,” Emmanuel Abate, Cytiva’s president, genomic medicine, told GEN in an interview held during the Biotechnology Innovation Organization (BIO) International Convention, held at the San Diego Convention Center.
“We know that there are still some significant challenges that need to be addressed: How to improve consistency of manufacturing? How do we help our customers reduce the cost of manufacturing? How do you help your customers scale up? Because we know that with the number of patients that are being treated, infrastructure is a true challenge for CAR T providers. That’s really what we had in mind with this platform,” Abate added.
Sefia has been designed as a flexible, modular cell therapy manufacturing platform offering greater automation than previous cell therapy platforms, thus lowering the potential for human error in manufacturing the treatments. That’s no small challenge since manufacturing practices for CAR T therapies have depended heavily on manual labor given the personalized nature of the autologous treatments.
Through greater automation, Cytiva says, Sefia reduces the risk of batch failure and saves users money. The reduced cost, Abate said, creates the potential for lowering the sky-high cost of cell therapies. The list price for a treatment course of Yescarta, for example, is $424,000, though Kite emphasizes that most people pay less through insurance or Medicare, as well as patient access programs.
Yescarta is administered in the United States at over 120 authorized treatment centers, primarily large healthcare systems—though most customers for Sefia are expected to be developers of cell therapies.
“When we compare how some of our customers are using our legacy platform and how they’re going to use this new platform, we think we can take 30% of labor time/labor cost out. It is of that order of magnitude. Of course, it all depends where they start from, but we have fairly significant numbers here.”
Another significant number for Sefia, according to Cytiva, is that the platform’s design is scalable enough to help increase manufactured doses by up to 50% per year compared to industry standard.
“It can be used in preclinical, it can be used in the clinic, and it can be used for large-scale manufacturing,” Abate said. “We’ve seen a lot of advanced therapies fail because early developers start manufacturing without keeping in mind what large-scale commercial manufacturing is going to look like. So, what we want to offer customers is a path to commercial therapies. This platform is flexible enough to enable pretty much any type of cell work at the discovery level, but then can scale up to commercial scale manufacturing.”
Growing market
Based in Marlborough, MA, Cytiva is a unit of Danaher that was re-launched in 2020 after Danaher spent $21.4 billion for the former BioPharma business of GE Healthcare Life Sciences. Danaher oversees a global family of more than 20 operating companies focused on biotech and life sciences, as well as diagnostics, water quality, and product identification.
Cytiva sees a growing market for Sefia in the expanding universe of cell therapies. At present, 10 autologous CAR T cell therapies have won regulatory approvals allowing their use in the United States, the European Union, and several Asia-Pacific countries.
In addition to Yescarta and Tecartus, FDA-approved CAR T therapies include:
- Abecma® (idecabtagene vicleucel), co-marketed by Bristol Myers Squibb (BMS) and 2seventybio
- Breyanzi® (lisocabtagene maraleucel), also marketed by BMS
- Kymriah® (tisagenlecleucel), marketed by Novartis
- Carvykti®, co-marketed by Johnson & Johnson’s Janssen Biotech and Legend Biotech (ciltacabtagene autoleucel)
Also, more than 1,000 cell therapy clinical trials are underway globally, a number that has grown in recent years and is expected to further increase. According to ClinicalTrials.gov, 773 cell therapy trials are now recruiting patients, while another 192 are not yet recruiting and 190 are active studies but not recruiting patients.
That market has attracted other developers of cell therapy manufacturing platforms. On May 29, the same day Cytiva announced Sefia, London-based Ori Biotech said it had commercially launched its IRO platform, which is also designed to automate, digitize, and standardize labor-intensive parts of cell as well as gene manufacturing workflows.
According to Ori, IRO reduces labor by up to 70%, cuts the cost of goods by up to 50%, shrinks processing times by up to 25%, and accelerates tech transfer times from months to weeks. The first IRO units are set to reach the market in the first quarter of 2025.
On May 21, Tokyo-based Astellas Pharma and Kitakyushu, Japan-based Yaskawa Electric announced they have begun talks to create an innovative cell therapy ecosystem by integrating pharmaceutical and robotics technologies. The companies said they will discuss potentially developing a platform designed to seamlessly link early-stage research to commercialization by using the Maholo robot developed by the Robotic Biology Institute, a Yaskawa subsidiary, to manufacture high-quality products and shorten the R&D timeframe for producing cell therapies.
Astellas has used Maholo since the end of 2017 to advance drug discovery and manufacturing technology research in cell therapy.
“Those are good signals from the industry. The industry believes that CAR T therapies have a future. That’s why we invest in their manufacture,” Abate said. “The industry believes that we are not at the end of designing the manufacturing platform that will enable CAR T as a mainstream therapy. So, I look at the competition as an encouragement.”
Cytiva reasons it can outcompete those and other platform developers through Sefia, which unites the Sefia Select system and the Sefia expansion system. The Sefia Select system uses automation to carry out cell isolation, harvest, and formulation—while the Sefia expansion system automates the cell activation, transduction, and cell expansion steps.
Cytiva will market Sefia directly to customers through its commercial organization.
“At Cytiva, we believe strongly in advanced therapy. We believe strongly in technology as an enabler to those therapies making it to market,” Abate said. “We think a lot of the answer here is in how we can improve the manufacturing process of those therapies.”
