Cell and gene therapies (CGTs) show great promise in treating diverse conditions, from cancer to neurodegenerative diseases. However, alongside their potential benefits, they present significant and potentially costly challenges. Unlike conventional therapies, which often require storage within ambient or occasionally refrigerated (2 to 8°C) or frozen (-15 to -25°C) conditions, CGTs demand ultra-cold temperatures ranging from –4°C to cryogenic levels below -150°C, rendering them highly sensitive to temperature fluctuations. Even the slightest deviation from these temperatures can compromise product viability.
Viewed as disruptive to traditional therapies, biotech’s are prioritizing CGTs development, driving the need for robust cold chain solutions. Many are partnering with contract drug manufacturing organizations (CDMOs) to enhance supply chain efficiency and access new markets. In turn, CDMOs are investing in innovative technologies to support this growing demand.
Biorepositories
Companies developing CGTs require suitable flexible storage capacity within the required temperature ranges for their samples. However, this can pose a significant challenge for smaller companies, as they often lack the necessary resources, time, or funding to establish in-house facilities. CDMO’s provide immediate access to state-of-the-art facilities and specialized expertise at a lower cost compared to building an in-house biorepository. Additionally, they heavily invest in backup systems, risk mitigation strategies, and cutting-edge technology to ensure the safety of stored samples
Furthermore, CDMOs can offer more than just storage solutions. For instance, Thermo Fisher Scientific extends its capabilities to provide innovative cold chain laboratory services, including sample processing and analysis in cutting-edge labs. This comprehensive approach ensures efficient handling of samples throughout the storage process, enhancing overall efficiency and quality control.
Labeling
Labeling materials maintained at ultracold temperatures pose significant challenges, necessitating innovative solutions. Conventional labels struggle to adhere properly to vialed products stored at cryogenic temperatures. Given that CGTs demand ultracold or cryogenic storage to preserve their integrity, packaging must incorporate labels capable of enduring subzero temperatures.
CDMOs have developed labeling solutions for vialed products stored at cryogenic temperatures. Utilizing specialized labels developed specifically for ultralow temperatures ensure adhesion to the vial. Additionally, time out of environment can impact the viability of CGTs. By utilizing specialized secondary packaging and labeling suites, coupled with a skilled labeling team, CGTs can be efficiently packed and labeled within an environment that seamlessly maintains required temperature settings without any disruptions.
Distribution and logistics
Distributing CGTs involves the complex task of transporting these delicate and high value products across large distances, often spanning multiple countries. This has driven the need for tracking technology and specialized cold chain packaging solutions to ensure the integrity and quality of products during transit.
CDMO’s have embraced these technologies to provide their customers both visibility and confidence in their products safety. Real-time tracking solutions enable proactive monitoring, risk mitigation, and swift responses to temperature deviations during transit. This ensures the integrity of products is upheld while maintaining regulatory compliance. Cold chain packaging innovations have introduced various temperature-controlled solutions, including cryogenic dry shippers and passive solutions utilizing insulators and coolants. These designs ensure stability over longer distances and enhance resilience against challenges such as customs delays and extreme weather conditions.
Experienced CDMOs can use their expertise to identify suitable monitoring and cold chain shipping solutions personalized for each customer, resulting in time savings, cost reductions, and ensured safety of product.
Global infrastructure
With the growth of CGTs clinical trials, having access to a robust infrastructure capable of providing end-to-end cold chain solutions in strategic locations in key markets worldwide is crucial for ensuring swift and reliable access to needed services and accelerating time to treatment. Thermo Fisher Scientific has made substantial investments in recent years to strengthen cold chain solutions throughout its global network, establishing new facilities and expanding existing ones. A notable example is the establishment of a Cell and Gene Therapy Center of Excellence facility in Bleiswijk, Netherlands, aimed at providing comprehensive cold chain solutions across Europe in response to increasing demand in the region.
As advancements in healthcare continue to evolve, CDMOs like Thermo Fisher Scientific consistently invest in strengthening their cold chain solutions with new and innovative technologies to support the growing demand for CGT products- becoming strategically positioned to fulfill the evolving needs of their customers.
The editorial staff had no role in this post's creation.