It is worth noting that the Cell and gene therapies- CGTs have gone on to show immense promise when it comes to treating diverse conditions, right from cancer to neurodegenerative diseases. But, alongside their potential perks, they go on to present with significant and potentially expensive challenges too. Unlike the conventional therapies, which often go on to require storage within the ambient or occasionally refrigerated 2 to 8°C or frozen -15 to -25°C conditions, CGTs go on to demand ultra-cold temperatures, which happen to range from –4°C to cryogenic levels that are below -150°C, hence rendering them highly sensitive when it comes to temperature fluctuations. The fact is that even the slightest deviation from these kinds of temperatures can go on to compromise product viability.
Viewed as disruptive when it comes to traditional therapies, biotech’s happen to be prioritizing CGT development, thereby pushing for the need for robust cold chain solutions. There are many who are partnering with contract drug manufacturing organizations – CDMOs so as to enhance supply chain efficiency as well as access new markets. In turn, CDMOs happen to be investing in innovative technologies in order to support this growing demand.
Biorepositories
Companies that happen to be developing the CGTs need an apt flexible storage capacity in the required temperature zones in terms of their samples. But this can go on to pose a significant issue for smaller companies, as they go on to often lack the necessary resources, time, or even funding in order to establish in-house facilities. CDMOs offer immediate access to the state-of-the-art facilities as well as specialized expertise at a lower cost as compared to building an in-house biorepository. Moreover, they heavily invest in backup systems, risk mitigation strategies, along with cutting-edge technology so as to ensure the safety of the stored samples.
Moreover, the CDMOs can go on to offer more than just storage solutions. For example, Thermo Fisher Scientific happens to extend its capabilities in order to provide innovative cold chain laboratory services, which include sample processing as well as analysis in cutting-edge labs. This comprehensive approach makes sure of efficient handling of samples all across the storage process, elevating overall efficiency and even quality control.
Labeling
Labeling materials that happen to be maintained at ultracold temperatures go on to pose significant challenges, thereby urging innovative solutions. Conventional labels go on to struggle to adhere properly to vialed products stored when it comes to cryogenic temperatures. Given that the CGTs demand ultracold or cryogenic storage so as to preserve their integrity, packaging has to incorporate labels that are capable of enduring subzero temperatures.
CDMOs have gone on to develop certain labeling solutions when it comes to vialed products stored at cryogenic temperatures. Making use of specialized labels developed especially for ultralow temperatures makes sure of adhesion to the vial. Moreover, time out of the environment can impact the viability of CGTs. By way of utilizing specialized secondary packaging as well as labeling suites, teamed with a skilled labeling team, CGTs can indeed get efficiently packed and also labeled in an environment that goes on to seamlessly maintain the required temperature settings sans any sort of disruptions.
Distribution as well as logistics
Distributing CGTs happens to involve a complex task in terms of transporting these delicate as well as high value products over large distances that often span multiple countries. This has indeed gone on to push the need for tracking technology as well as specialized cold chain packaging solutions to make sure of the integrity as well as quality of products during the phase of transit.
CDMOs have gone on to embrace these technologies in order to provide their customers with both visibility as well as confidence in their products safety. Real-time tracking solutions help with proactive monitoring, risk aversion, and also swift responses to the temperature deviations during the transit. This happens to make sure that the integrity of products is upheld while at the same time also maintaining regulatory compliance. Cold chain packaging innovations have gone on to introduce numerous temperature-controlled solutions, such as cryogenic dry shippers, as well as passive solutions which go on to make use of insulators as well as coolants. These designs make sure of stability over longer distances and even happen to enhance resilience against challenges that range from customs delays to even extreme weather conditions.
It is well to be noted that experienced CDMOs can make use of their expertise so as to identify suitable monitoring as well as cold chain shipping solutions that get customized for each customer, thereby resulting in time savings, a decrease in costs, and also a sure shot safety of the product.
Global Infra
The fact is that with the growth of CGTs clinical trials, getting an access to a robust infrastructure that is capable of going ahead and offering end-to-end cold chain solutions across the strategic locations in key markets throughout the world is crucial for making sure of swift as well as a reliable access to the required services as well as accelerating time when it comes to treatment. Thermo Fisher Scientific has gone on to make quite a substantial investment in the years that have gone by so as to strengthen cold chain solutions all across its global network, thereby establishing new facilities and, at the same time also expanding the existing ones. A significant example in this regard is the establishment of the Cell and Gene Therapy Center of Excellence facility at Bleiswijk, based in the Netherlands, which is aimed at providing comprehensive cold chain solutions throughout Europe in response to the ever-increasing demand across the region.
The fact is that as advancements within the healthcare gamut continue to evolve, CDMOs such as Thermo Fisher Scientific consistently go on to invest in strengthening their cold chain solutions with new as well as some innovative technologies in order to support the growing demand when it comes to CGT products and hence become more strategically positioned in order to fulfill the ever-evolving needs as far as their customers are concerned.
