High Costs of Cell Therapy, Cryopreservation Technology May Be Key to Breakthrough

The first cell therapy approved by the U.S. FDA—Dendreon's Provenge for treating prostate cancer—faced setbacks upon its market launch in 2010. As an autologous therapy, its manufacturing and delivery processwas logistically complex, and reimbursement also posed a challenge.

Although the cell therapy market still faces similar challenges, Alireza Abazari, Senior Director of Cell Processing and Cryopreservation at BioLife Solutions, believes that Dendreon's failure "provided valuable lessons for subsequent therapies." Today, cell therapy manufacturers place greater emphasis on logistics processes, including extending cell viability through advances in cryopreservation technology.

These innovations are expected to improve the accessibility of cell therapies. Early therapies such as Atara Biotherapeutics' Ebvallo—the world's first allogeneic T-cell immunotherapy approved in Europe in 2022—and Gamida Cell's Omisirge, an allogeneic stem cell transplant product for blood diseases, have begun to reshape the cell therapy landscape.

Allogeneic therapies benefit thousands of patients through large-scale single-batch production, rather than the one-to-one manufacturing of autologous therapies, thereby bringing scalability to the market. However, this requires planning for cryopreserved cell banks, which is BioLife's specialty, and cryopreservation processes are continuously being optimized, says Abazari.

BioLife collaborates with several major players in the cell therapy field, including Gilead's Kite Pharma, Bluebird Bio, and Bristol Myers Squibb. In April of this year, the company acquired Panthera CryoSolutions to advance ice recrystallization technology, which reduces temperature fluctuations and enables the freezing of more cell types without damage, says Abazari.

Here, we spoke with Abazari about the challenges facing the cell therapy market, potential solutions for allogeneic therapies, and advances in cryopreservation technology.

This interview has been edited for length and clarity.

Interview Transcript

PHARMAVOICE: How do you view the current cell therapy field and the difficulties in breaking through the market?

ALIREZA ABAZARI:When discussing the challenges of cell therapy, price is the core issue. The development of such therapies and patient delivery require enormous upfront investment—often hundreds of millions or even billions of dollars. Especially since most current therapies are autologous, this constitutes a significant part of the cost. In contrast, chemically synthesized drugs are easier to manufacture and scale. One solution is to shift toward the allogeneic pathway.

In addressing cost and scalability issues, how do you think the field will evolve?

As long as payers exist, autologous therapies will continue to grow. They paved the way and will persist until surpassed in efficacy and price. Autologous therapies have become the gold standard, but given cost pressures, people will attempt to bypass this obstacle through genetically modified allogeneic therapies. This is one way to reduce expenses, and the field will see growth.

What is cryobiology, and why is it crucial to the viability and accessibility of cell therapies?

When biological tissue leaves the human body, it enters a hypoxic state due to lack of oxygen, and nutrient deficiency leads to stress responses and reduced viability. Cryopreservation stops biological activity by freezing, theoretically allowing cells to remain in a state for thousands of years. But the freezing and thawing process must be done properly to avoid damaging cells, which is the key to current preservation science. This is especially important for allogeneic therapies, as tens of thousands of doses need to be produced before patients are ready, relying on tissue banks. Cryopreservation is the cornerstone of allogeneic therapies and a core element in reducing the cost of cell therapies in the future.

What milestones or challenges do you hope the field of cryopreservation will overcome in the future?

Cryopreservation faces physical size challenges at different scales. Small molecules, viruses, antibodies, vaccines, mRNA, etc., have been thoroughly studied. Cells such as bone marrow or umbilical cord blood have been successfully preserved for over 60 years. But certain cell types are more sensitive to freezing, such as neurons in Parkinson's disease therapies or human cartilage in arthritis treatments, requiring special methods. I previously worked in a laboratory at Harvard, focusing on methods for freezing organs like the heart, liver, or kidneys. My wish is to see, within my lifetime, human organ banks used for transplantation.