Expert perspective: Advancing ultra-low temperature labels for advanced therapies and vaccines
The COVID-19 pandemic has fundamentally transformed the landscape of healthcare, particularly in the fields of advanced therapies and vaccines. One of the pivotal challenges that emerged is the need for reliable clinical labeling solutions that can withstand ultra-low temperatures. Prior to the pandemic, the demand for such ultra-low temperature labels was relatively limited. However, the urgent need to store and transport vaccines at temperatures as low as –80°C and some therapies stored at –196°C has brought this issue to the forefront. Thermo Fisher Scientific has responded to this challenge by investing in and developing innovative ultra-low temperature labels, demonstrating their technical leadership and commitment to solving critical industry issues.
To gain deeper insight into ultra-low temperature labeling solutions, we conducted an interview with Julia Field from Thermo Fisher Scientific. Julia is a Sr. Product Manager in the Clinical Trials Division supporting clinical labels with a focus on clinical supply technology and innovation. Julia has a background in biological sciences and has previously worked in clinical diagnostics and bioproduction prior to joining Thermo Fisher in 2016. Julia shares her expert insights in clinical labeling, highlighting the challenges of ultra-low temperature labeling and the benefits of qualified solutions.
Q: Why are ultra-low temperature labels important in the context of advanced therapies and vaccines, particularly post-pandemic?
A: The COVID-19 pandemic highlighted the critical need for reliable ultra-cold logistics solutions, especially for vaccines that require storage at temperatures as low as –80°C. Before the pandemic, the demand for such extreme storage conditions was relatively niche. However, the rapid development and deployment of mRNA vaccines and other therapies which need to be stored at these ultra-low temperatures, underscored the importance of having labels that can withstand such conditions without failure. Reliable labeling ensures that critical information remains intact throughout the product's lifecycle, which is essential for maintaining safety, efficacy, and regulatory compliance for the clinical trial.
Q: What are the main challenges associated with ultra-low temperature labels?
A: The primary challenges include adhesive performance and material durability. Ultra-low temperature labels must adhere firmly to primary packaging surfaces at temperatures as low as –80°C or and in some cases stored at –196°C (liquid nitrogen). They must also resist cracking, peeling, and fading, which can compromise the readability of critical information. Vaccines specifically have more stringent requirements, as they can’t be thawed while the label is being applied. The pandemic has made it clear that failing labels can disrupt the entire supply chain causing delays in timelines and unnecessary costs.
Q: How does Thermo Fisher’s solution differ from what’s currently available in the industry?
A: Thermo Fisher’s ultra-low temperature labels are specifically designed to withstand extreme temperatures. We performed qualification studies to identify the optimal label material with minimal risk of failure. Our labels comprise advanced adhesives and qualified materials to ensure their integrity and performance when applied and stored at ultra-low temperatures. This contrasts with many labels used in the industry, which may not be designed for such harsh conditions, and therefore fail to perform reliably. Our R&D investment in ultra-low temperature labeling has enabled us to select and qualify solutions that meet these new demands.
Q: How do Thermo Fisher’s ultra-cold labeling solutions enhance the overall safety and efficiency of the supply chain?
A: By ensuring that labels remain intact and readable, our solutions help maintain the traceability and integrity of products throughout the supply chain. This reduces the risk of errors, enhances compliance with regulatory requirements, and ultimately ensures that patients receive their clinical trial product in a timely manner. The pandemic has shown that any disruption in the supply chain can have significant consequences in delays and costs, making Thermo Fisher’s ultracold labeling solutions ideal.
Q: What feedback have you received from customers requiring ultra-low temperature labels?
A: Customers have a need for labels that demonstrate robust performance and durability, while maintaining material integrity, as the vaccines can't be thawed while the label is applied. Due to these stringent requirements, we have had to expand our standard material library and work to evaluate and qualify the most robust materials to meet these specifications. Customers appreciate the peace of mind that comes from knowing their products are securely labeled and traceable, even under the most challenging storage conditions. The pandemic has led to increased scrutiny and higher standards, and our solutions have met these expectations.
Thermo Fisher’s ultra-low temperature labels represent a significant improvement in the field of advanced therapies and vaccines. By addressing the unique challenges of ultra-low temperature environments, Thermo Fisher continues to demonstrate its technical prowess and leadership in solving critical industry challenges.
To learn more about Thermo Fisher’s ultra-low temperature labeling capabilities, visit our ultra-cold supply chain management page.
