From advanced supply chains and personalized medicines, to interplanetary exploration, cryopreservation could have a profound impact on the future of healthcare and therapeutics. Advanced therapy developers and researchers are doing their utmost to improve and accelerate the journey of their products from the bench to the bedside. The supporting transport, logistics, and storage specialists tasked with the preservation and delivery of those products are working just as hard to improve their own products and services – and keep pace with a rapidly developing modality. Cryopreservation is seen as a key technology for advanced therapy supply chains, but it’s a technique with many challenges. In this Medicine Maker article, three experts from the cryopreservation field discuss what is happening now, and what could happen in the future. Read Priya Baraniak, Ph.D.‘s responses on the trends, challenges, and possibilities of cryopreservation for cell and gene – and how it can freeze time in manufacturing.
How has the demand for cryopreservation changed with the development of advanced therapies?
PB: As we see more and more cell and gene therapies launch, one thing I think we’re all very passionate about is their global accessibility and democratization. While we still see a strong preference amongst many cell therapy developers for fresh tissues and cells – especially nascent biotechs – fresh cells pose a real logistics challenge. The transportation and storage of these materials runs against the clock. Cryopreservation enables extended storage and global transport. We’re essentially freezing them in time.
Cryopreserved products have already been embraced by large pharma and established biotech companies. Until we have better processes for lyophilization, or next generation solutions to circumvent cryopreservation, it’s going to continue to be the path forward – even to the point of the cryopreservation and transplantation of entire organs.
As we see cell and gene therapies continue to expand in their indications, we’re going to continue to see the increased need for cryopreservation technologies, but cost is definitely a major consideration, along with any regulatory hurdles that might exist. The industry, as a whole, needs more standardization and decentralized manufacturing. Cryopreservation does offer some standardization, but the regulations are going to be very important.
Can you elaborate on the advantages of cryopreservation over conventional methods?
PB: The IVF field is a major driver of cryopreservation in healthcare and medicine, but beyond fertility, biobanking is still something we do routinely. We have newer options coming to market now, and ideas about first line treatments for patients versus second, third, fourth, fifth line treatments. Today’s immunotherapies follow chemotherapy, radiation, monoclonal antibodies or combinations thereof. Many of these patients’ bodies are ravaged by the time we are able to go in and perform leukapheresis. Prophylactic apheresis at the point of diagnosis is an emerging idea, and when nothing else has worked, we can try CAR-T therapy using material from the patient from when they were healthier. The hope is that these therapies become first line therapies, rather than last hope chances.
Are there any inhibiting factors that developers might face in accessing or utilizing cryo-based solutions?
PB: Bringing automation in will drive down costs and boost standardization. Until then, equipment and equipment costs are definitely an area of limitation. Workforce development is another that needs further attention. Cryobiology is a very specific field; there aren’t many cryobiologists out there with the very distinct knowledge of what it takes to cryopreserve cells, tissues, and living materials. You need someone who understands cell biology and the physics of freezing, temperature changes, and nucleation. It’s a multidisciplinary field that requires more technical experts to drive it forward.
There are regulatory hurdles, too. Dimethylsulfoxide (DMSO) has been quite ubiquitous and is used routinely in cryopreservation, but we have to make regulators comfortable with the new technologies, materials, and reagents coming to market.
How much optimism is there in the industry when it comes to attracting and developing new talent?
PB: To get the type of workforce that we need for the growth that this industry could see in the next 10 to 25 years, we need to look at programs at the community college level, such as the vocational technical programs we have for other trades. You don’t need a full degree; you can learn basic skills on aseptic technique, cryopreservation, and other elements without one. Traditional schooling is not for everyone and we’re seeing more and more that a PhD is not paramount. What’s more important is attention to detail, hunger and drive, and the need to continue to make science “sexy”.
We’ve seen a lot of hardship in the industry since 2022, including brutal layoffs and a hard funding landscape. It’s incumbent upon leaders in the industry to keep that optimistic outlook and to remain bullish on this, even in the face of adversity. We need to make sure the younger generation isn’t turned away. We need to show passion – that inner fire – in our personal missions.
What do you think cryopreservation is likely to continue to contribute to the advanced therapy sector in the future?
PB: Personalized medicine and the ability to bank cells for future use will become more and more popular. Will we be able to cryopreserve ourselves? Walt Disney has, supposedly! Personally, I wouldn’t want to, but some do!
I can foresee applications in space exploration, and sending cells to space, which is being done by SpaceX and others to discover the effects of microgravity and radiation on different cell types. How might this affect life on the moon or Mars? Maybe someday we will have to leave Earth, or choose to leave Earth. There’s a whole new frontier out there in the realm of science fiction, but maybe 50 or 100 years from now, it’s conceivable that we might need cryopreservation for things like that.
