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Supply Chain Archives

12/11/2025

Setting the Benchmark for Quality in Cell and Gene Therapy Logistics

Quality in cell and gene therapy (CGT) is the foundation that determines whether a therapy reaches a patient intact and effective. As the industry increasingly scales from early development of CGTs to global commercialization, the margin for error narrows as volume and complexity increase. Standards like ISO 21973 provide a framework, but true industry leadership comes from how those standards are applied. In this, Cryoport Systems is setting that benchmark.

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10/22/2025

Beyond the Box: Why Shipping System Qualification Matters in Advanced Therapies

For advanced therapy logistics, quality isn’t limited to what happens inside the manufacturing suite. It extends across the entire supply chain, from packaging and transport to the systems that safeguard material integrity at every handoff. Yet one of the most critical (and often underestimated) steps in ensuring integrity is a shipping system qualification.

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07/22/2025

What’s Next for the CGT Industry? Mid-Year Check-In from the Leadership Team

We’re halfway through 2025, and the cell and gene therapy (CGT) landscape stands at a crossroads. Innovation continues to advance, yet the infrastructure required to support commercialization remains under pressure. To assess the current state of the industry and what’s ahead, Cryoport Systems gathered candid insights from our internal leaders across functions, from product development and commercial strategy to operations and client engagement.

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06/27/2025

Bridging the Gaps: How Cryoshuttle® Enhances First and Last Mile Resilience

For advanced therapies, the most vulnerable parts of the transportation journey aren’t always the longest. In fact, the greatest risks often occur in the shortest distances. While intercontinental transport and customs clearance are well-known hurdles, both the first and last mile remain highly vulnerable to disruption.  Cryoport Systems developed our Cryoshuttle® local pickup and delivery services to help close the gap between global transport lanes and local handling environments.

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06/13/2025

Expanding Clinical Trials Internationally in the ATMP Space

Expanding an advanced therapy clinical trial internationally is an exciting milestone but can be daunting for researchers and biotech teams. International trials involve challenges like country-specific regulations, Qualified Person (QP) release, and complex logistics. Early planning for these issues can help avoid delays and ensure progress.

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03/24/2025

Strengthening Global ATMP Logistics: How Cryoport Systems’ Netherlands Facility Supports Temperature-Controlled Supply Chains

The success of ATMPs depends on more than just scientific breakthroughs, it requires a highly controlled, risk-mitigated supply chain that ensures product integrity from research through commercialization. With cell and gene therapies moving across multiple clinical sites, manufacturing facilities, and regulatory jurisdictions, developers need a logistics partner that can support seamless, temperature-controlled supply chain management at a global scale. 

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03/12/2025

The Gateway to Europe: How Cryoport Systems’ Stevenage Supply Chain Hub Supports ATMP Development 

For UK-based Advanced Therapy Medicinal Product (ATMP) developers, access to European clinical trial sites and commercial markets is a critical component of a successful growth strategy. Yet, navigating regulatory barriers, customs challenges, and supply chain complexities can create unnecessary delays, increase costs, and put the integrity of sensitive biologics at risk.

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03/04/2025

How Our Recent Innovative Solutions Meet Today’s Supply Chain Challenges  

When advanced therapy organizations place innovation at the center of their approach to solving supply chain challenges, they prioritize the most important person involved – the waiting patient. An innovative, patient-centric approach reframes obstacles to focus on solutions that can ensure the vitality and protection of sensitive materials throughout every stage and phase of the journey to the patient’s bedside. 

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01/06/2025

The Future of Gene Therapy Logistics – A Pivotal Moment

Gene therapy is set to transform healthcare, but its success depends on logistics systems that can adapt and scale in line with the industry’s growth. Cryoport Systems is proud to support this exciting frontier with logistics solutions that prioritize product integrity, security, and compliance.

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12/30/2024

Supporting Compliance and Reducing Risk in Gene Therapy Logistics

When it comes to high stakes logistics in the gene therapy sector, adherence to regulatory standards isn’t just a box to check—it’s essential to delivering therapies that maintain integrity from production to patient. Cryoport Systems understands the unique risks in this space and has built compliance and risk mitigation into the very design of the Cryoport Elite™ Ultra Cold shipping system.

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