The Importance of Maintaining Ultra-Cold Temperatures for Cell and Gene Therapies

MaxiLog Alert: Because every degree matters in the cold chain

Key Takeaways:

• Maintaining temperatures as low as -80°C (-112°F) or even -200°C (-328°F) throughout the supply chain is vital for preserving the viability and effectiveness of CGT products.
• Temperature variations can severely impact the delicate cellular structures, genetic material, proteins, and viral vectors used in CGTs, potentially reducing therapeutic efficacy or damaging the product.
• Use strategies such as advanced thermal packaging, temperature monitoring devices, automated temperature control systems, and collaboration with specialized logistics partners.
• MaxiLog Alert and MaxiLog Alert -80 products allow for proactive intervention, enhanced visibility, a data-driven approach to logistics optimization, regulatory compliance, and better decision-making while transporting CGTs requiring low temperature storage.

Cell and gene therapies (CGTs) have the potential to revolutionize healthcare by offering innovative treatments for complex diseases. However, these products require low-temperature storage and transport. 

To ensure the effectiveness of these therapies, it is crucial to maintain a proper environment throughout the entire supply chain. This involves using specialized storage and transportation methods to sustain temperatures as low as -80°C (-112°F) or even -200°C (-328°F). This is essential for ensuring that patients receive the full benefits of these cutting-edge treatments.

The increasing reliance on cold temperatures underscores the importance of continuous monitoring in healthcare logistics. Data loggers, like SpotSee’s Maxilog Alert series, enable monitoring so you can ensure optimal temperatures, minimize risks, and deliver viable products. 

Fragile cargo

CGT products are unique – they are composed of viable mammalian cells, which means the cold chain must maintain a living product in a viable state throughout the product’s journey. 

The biological components of CGTs can be damaged by temperature fluctuations, including:

• Cells: The delicate cellular structures of CGTs can be significantly affected by temperature variations. Cell viability, proliferation, and differentiation may be compromised, leading to reduced therapeutic efficacy or cell death.
• Genetic material: The integrity of the genetic material (DNA or RNA) used in gene therapies is crucial for their successful delivery and expression. Temperature fluctuations can cause DNA or RNA degradation, leading to loss of gene expression and therapeutic effect.
• Proteins: Many CGTs rely on the expression of specific proteins for their therapeutic action. Proteins can denature or misfold when exposed to inappropriate temperatures, affecting their function and potentially causing adverse effects.
• Viral vectors: Some gene therapies use viral vectors to deliver genetic material into target cells. While most viral vectors don’t require an ultra-cold chain (-200°C or lower), some are sensitive to temperature fluctuations, which may impact their stability and ability to transduce cells effectively.

The challenges of the CGT cold chain

It’s mission-critical. The cold chain must be maintained. Sustaining appropriate temperatures when transporting CGTs faces the same challenges any cold chain faces. These include extended transit times and potential delays, variations in ambient temperature during air or ground transportation, risk of human error in handling and storage procedures, and limitations of traditional monitoring methods (e.g., paper charts) enhancing visibility.

1. Utilize advanced thermal packaging: Invest in high-tech thermal packaging solutions designed to maintain temperatures for an extended period. This helps address extended transit times and temperature variations during transportation.
2. Implement temperature monitoring devices: Incorporate temperature monitoring devices to ensure constant surveillance of the therapies’ temperature and prompt alerts in case of deviations.
3. Automate temperature control: Integrate automated temperature control systems within transportation containers to regulate internal temperature effectively, reducing the risk of human error in manual management.
4. Collaborate with specialized logistics partners: Partner with logistics companies specializing in temperature-sensitive pharmaceuticals to maintain cold temperatures throughout the transportation chain.
5. Engage in continuous improvement: Regularly review and refine transportation processes based on feedback and data analysis from monitoring devices, identifying areas for improvement.

Implementing these strategies can enhance the efficiency and reliability of transporting ultra-cold therapies while overcoming challenges associated with temperature maintenance.

SpotSee’s MaxiLog Alert Data Loggers

SpotSee’s MaxiLog Alert data loggers are the ultimate solution for temperature monitoring of CGT shipments. These innovative data loggers are specifically designed to ensure the safe transport of sensitive goods by monitoring temperature-sensitive products throughout the journey.

The MaxiLog Alert series combines robust temperature monitoring with simple data retrieval – a built-in USB interface with direct download to software. Available for standard and low-temperature monitoring, these single and multi-use loggers offer options to customize start time delay, sampling intervals, high and low alarm values, alarm type, and measurement data.

The key features of MaxiLog Alert include:

• Wide Temperature Range (-29°C to +72°C / -20°F to +162°F) or (-80°C to +30°C / -113°F to +86°F): Accommodates varying requirements ofCGT shipments, providing the versatility needed to monitor a range of temperature-sensitive products.
• High-accuracy temperature recording ensures precise data collection to track temperature fluctuations with confidence and accuracy.
• Advanced alarm system: Equipped with a sophisticated alarm system featuring pre-set thresholds, ensuring immediate notification of any deviations from the desired temperature range. This proactive approach allows for timely corrective actions, minimizing risks of temperature excursions.
• Long battery life: With extended battery life, the MaxiLog Alert data loggers offer uninterrupted monitoring capabilities, even during long-haul journeys, providing peace of mind that your goods are continuously monitored.
• Compatibility: Seamless integration with existing logistics workflows and data management systems simplifies the monitoring process, allowing for easy access to data and efficient management of CGT shipments.

MaxiLog Alert data loggers from SpotSee are the ideal solution for CGT shipments. They offer robust features and reliable performance to safeguard your valuable cargo. Trust MaxiLog AlertT for comprehensive temperature monitoring that meets the demands of the most sensitive shipments. Looking for ultra-cold monitoring solutions as well? Contact SpotSee for additional solutions. 

A flawless journey requires visibility

Monitoring with MaxiLog Alert is a comprehensive solution for ensuring the safety and efficacy of ultra-cold CGTs:

• Proactive intervention: With Maxilog Alert, you can take proactive measures to maintain optimal temperatures and prevent excursions, ensuring the integrity of your cargo throughout the journey.
• Enhanced visibility: MaxiLog Alert provides improved visibility, allowing you to pinpoint potential issues and take corrective actions promptly, minimizing the impact on your operations.
• Data-driven approach: By leveraging the logged data, you can adopt a data-driven approach to optimize logistics and minimize risks, leading to more efficient and cost-effective transportation of low-temperature dependent CGTs.
• Regulatory compliance: MaxiLog Alert helps streamline compliance with regulations related to CGT transportation, ensuring that you have the data backup you need for all requirements and standards.

MaxiLog Alert also enables better decision-making. Data logging and alerts mean you can make informed decisions on the go to respond quickly to any potential issues that may arise during transportation.

Overall, SpotSee offers comprehensive solutions like MaxiLog Alert for ensuring the secure and efficient transportation of CGTs, empowering you to make informed decisions, minimize risks, and optimize your logistics processes.

Preserve your cold chain

To ensure the safety and integrity when transporting CGTs, it’s essential to work closely with the temperature monitoring experts. Reach out to SpotSee with any questions, and get started today.