Advanced therapies represent a new era in medicine offering potentially curative treatments for previously intractable diseases.

However, their complex manufacturing processes and extreme temperature sensitivity present significant logistical hurdles, particularly when it comes to scalability and cold chain management. Bridging these gaps is crucial for ensuring these life-saving treatments reach patients worldwide.

One of the biggest challenges lies in the sheer complexity of CGT logistics. These therapies are often personalized, requiring precise tracking and chain of custody from the patient’s cells to the manufactured product and back to the patient. This intricate process demands a level of coordination and control far exceeding traditional pharmaceutical supply chains. Furthermore, the extremely low temperatures required for some CGTs, often down to -80°C or even cryogenic levels, add another layer of complexity. Maintaining this temperature throughout the entire journey, from manufacturing to administration, is paramount to preserving the therapy’s efficacy.

Scalability: Meeting Growing Demand for CGTs

Scalability is another major challenge. According to data from Medscape, which surveyed 17 US Cancer Centers, 25% of patients received CAR-T therapy after an average size-month wait, while another 25% participated in a CAR-T clinical trial. However, a staggering 50% of patients either enrolled in other types of trials, entered hospice or did not survive. These statistics underscore the urgent need to expand patient access to advanced therapies.

As the field of advanced therapies continues to rise and demand increases, existing logistical infrastructures must adapt to keep pace. The bespoke nature of these treatments, coupled with their temperature sensitivity makes it difficult to simply scale up traditional processes. Building a robust and scalable cold chain ecosystem requires significant investment in infrastructure, technology and expertise. This includes everything from specialized freezers, temperate-controlled transport containers, sophisticated tracking systems and highly trained personnel.

AI Strategies for Cold Chain Efficiency

So how do we bridge these gaps and ensure promising therapies reach the patients who need them? Marken implements several key strategies as a response. Foremost, we invest in advanced cold chain technologies to support the increase and complexity of advanced therapies. Next generation freezers, cryogenic storage solutions, and temp-controlled packaging are an integral part of our network and essential for maintaining the integrity of these sensitive therapies.

Automation and artificial intelligence (AI) will play an active role in optimizing cold chain logistics for advanced therapies. AI-powered systems predict temperature fluctuations, optimize routes, and proactively identify potential disruptions for real-time intervention. Automation also streamlines processes, reduces human error and improves efficiency.

The integration of sensors and interconnectivity through the Internet of Things (IoT) unlocks a new era of possibilities for intelligent cold chain logistics. However, for maximum effectiveness, these technologies must be reliable, robust and capable of maintaining the required temperatures for extended durations.

CGT Blockchain to Ensure Product Integrity

Real-time temperature monitoring and GPS tracking combined with 24/7 cell and gene control towers enhances visibility and control throughout the logistics network. The chain of custody systems for advanced therapies are imperative to ensuring timely processing and product integrity. Blockchain technology offers a promising solution for complete traceability and transparency in CGT logistics. By creating an immutable record of every step in the supply chain, from cell collection to administration, this level of transparency is critical for maintaining patient safety.

Strategic Partnerships & Skilled Specialists for CGT Excellence

Building strategic partnerships are vital in collectively assessing data to determine best practices.Effective cold chain logistics for advanced therapies require close collaboration between pharma companies, logistics providers, healthcare facilities and technology developers. Sharing data, expertise, and resources is essential for creating a seamless and efficient supply chain.

Investing in training and education is another crucial aspect. Handling and transporting advanced therapies demands specialized knowledge and skills. Training programs for logistics personnel, healthcare professionals and other stakeholders ensure therapies are handled correctly and administered safely. These programs should cover everything from temperature monitoring and handling procedures to regulatory requirements and industry best practices.

Future Outlook: Marken’s Role in Bridging the Gaps

The future of advanced therapies hinges on the ability to build a robust and scalable cold chain logistics ecosystem. By investing in advanced technologies, fostering collaboration, and embracing innovation, Marken bridges the gaps to ensure life-saving treatments reach patients across the globe.

Contact our Marken experts today and unlock the full potential of your clinical trials: