Within the world of advanced therapy medicinal products (ATMPs), the potential for personalized treatments offers hope for patients worldwide. However, as these therapies evolve, the focus sharpens on their safe transportation. As the industry prepares for a surge in new therapies, distribution challenges are made evident, raising critical questions about efficiency, accessibility, and patient treatment outcomes. In this article, John Coleman, Business Unit Director at ATMP logistics provider YSDS Life Science, explores the crucial role of logistics providers in ensuring the seamless transport of ATMPs in while adhering to the standards for an optimal vein-to-vein process.
The urgency to transition regenerative medicine from clinical trials to commercialization is growing significantly. According to the FDA, we will by next year see 20 new commercial regenerative medicine therapies enter the market annually. These predictions are also reflected fiscally with the ATMP sector being the fastest growing subsegment within the Life Science industry, projected to reach approximately USD 82.24 billion by 2032 with a predicted CAGR of 18.3%.
As the industry accelerates, so do the complexities and risks. The supply chain is put under immense pressure to streamline processes and increase speed whilst upholding operational excellence in an environment with no room to fail. But to reach end-to-end precision successfully, the industry is dependent on being able to transport these delicate therapies to patients swiftly and consistently at scale.
This cell & gene therapy (CGT) surge necessitates the safe and efficient delivery of thousands of individual doses. And so, standardization becomes imperative to mitigate errors and uphold best practices.
ISO 21973 and the challenge of adherence
In June 2020, the ISO 21973 standard was introduced. This is the first standard specifically tailored to address the transportation requirements for the cell and gene therapy supply chain. Recognizing the fragility and value of these products, ISO 21973 emphasizes the importance of maintaining optimal conditions throughout the transportation process.
While the existence of ISO 21973 standard provides a framework for safe transportation, adherence to these guidelines remains a challenge. Not all logistics providers may follow the standard diligently, potentially jeopardizing the integrity of CGT products during transit. Therefore, it’s imperative for CGT developers and stakeholders to be aware of the standard’s main sections to ensure the safe transportation of valuable therapies from vein to vein.
Cell and gene therapies are delicate treatments that require precise temperature control, which often means ultra-cold temperatures only achieved in long durations with vaporized liquid nitrogen. Pictured is a LN2 dry shipper, used to transport therapies in cryotemperatures.
Naturally, ISO standards are highly specified with intricate, exact details. For anyone interested in the full instruction manual, look here, or book a meeting with me – I would be glad to share my knowledge! But in the meanwhile, I here highlight the six main sections of the ISO 21973 standard that you and your logistics provider must meet for the Chain of Compliance.
THE KEY SECTIONS OF ISO 21973 STANDARD
1. Cell Transportation Specification
Emphasizes the importance of providing accurate information to your logistics providers, including regulatory classification, storage conditions and shipping details. It highlights the need for careful planning, risk mitigation and closely following specifications to ensure the safe transport of CGTs.
2. Shipping Container and Labelling
Details the requirements for shipping containers, emphasizing their design, validation, and labelling. It highlights the importance of proper documentation and traceability, especially for reusable containers, to maintain product integrity throughout the supply chain.
3. Operations
Focuses on the operational aspects of transportation, including proper container preparation, sealing, documentation and full traceability to maintain the chain of custody and identity. Also describes the necessity of solid backup solutions in case of unexpected challenges.
4. Organization
Highlights the importance of training of all involved in the transportation chain and having a robust Quality Management System (QMS) in place to ensure adherence to quality standards, performance monitoring and continuous improvement (for example ISO 9001).
5. Storage
Outlines the requirement for temporary storage facilities during transportation, including security measures, pest control and procedures for addressing equipment failures.
6. Documentation
Describes the necessity of maintaining proper documentation throughout the transportation process, including records of events, shipping containers, and regulatory compliance.
In the pursuit of advancing regenerative medicine, following standards is not only a question of regulatory obligation but also of ethical necessity. By complying with ISO 21973, we uphold the highest standards of safety and integrity, ensuring that the promise of ATMPs reaches those in need without compromise.
My strong recommendation for all therapy developers involved in moving products within this segment is to be extremely demanding and expect nothing less than the vendor abiding the standards of ISO 21973.
As previously mentioned, I would love to hear from you if you’re facing any logistical challenges with transporting your valuable ATMPs or other pharmaceutical products. My email is john.coleman@ysds.com
Learn how to successfully import your pharma related products into the US!
Finally, I do encourage you to take part of the information shared in our last webinar. We covered the topic of avoiding FDA holds and importing pharmaceutical products into the US with success. It was an appreciated webinar, so perhaps it will have great value for you as well.
About YSDS Life Science
YSDS Science provides global logistics solutions for clinical trials, advanced therapy, biotech, and more. We offer tailor-made GDP-certified solutions for your time and temperature-sensitive products, with full end-to-end visibility. Expect nothing less than 24/7 service from a dedicated team of experts. We offer quality beyond the ordinary.
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