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.
To address these challenges, Cryoport Systems has established a Good Manufacturing Practice (GMP)-compliant Global Supply Chain Hub in Stevenage, UK, positioned at the heart of one of Europe’s leading bioscience clusters. This facility provides specialized logistics, risk mitigation, and regulatory support, ensuring that UK ATMP developers can efficiently scale their operations across Europe.
Overcoming Supply Chain Barriers Between the UK and Europe
Since Brexit, UK-based life sciences companies have faced increased complexity in transporting clinical and commercial ATMPs to European sites. Key challenges include:
- Customs and Trade Barriers: Increased documentation requirements, delays at border crossings, and evolving trade regulations complicate shipments.
- Regulatory Hurdles: Compliance with both UK and EU regulatory frameworks (including EMA and MHRA requirements) demands careful and detailed oversight.
- Logistical Constraints: ATMPs require specialized temperature-controlled transportation, precise chain-of-custody tracking, and risk mitigation strategies to prevent product loss.
Without a streamlined, risk-mitigating supply chain strategy, UK-based developers risk delays, compliance issues, and higher operational costs when launching and scaling clinical trials in the EU.
A GMP-Compliant Supply Chain Hub in Stevenage
Cryoport Systems’ Stevenage Global Supply Chain Hub is designed to eliminate these obstacles, serving as a seamless gateway for advanced therapies like cell and gene therapies (CGTs) between the UK and Europe. This facility provides:
Temperature-Controlled Packaging & Logistics:
- Various Cryogenic shipping solutions.
- Cryoshuttle® local pickup and delivery service for local ATMP transportation.
- End-to-end chain-of-custody tracking and risk mitigation.
Regulatory & Trade Compliance Support:
- Expertise in EMA and MHRA regulatory requirements.
- Support for customs clearance, import/export regulations, and trade compliance to minimize delays.
Scalability for Clinical & Commercial Programs:
- Integrated logistics support for clinical trials, commercial distribution, and biopharmaceutical manufacturing.
- Strategic positioning to reduce transit time and cost for UK-based shipments into Europe.
Why Stevenage? A Strategic Location for ATMP Development
Stevenage is home to one of Europe’s most advanced bioscience clusters, including the Cell and Gene Therapy Catapult Manufacturing Innovation Centre. This ecosystem fosters innovation, collaboration, and streamlined access to specialized expertise in ATMP development, manufacturing, and logistics.
By situating our Global Supply Chain Hub within this ecosystem, Cryoport Systems provides unparalleled, integrated supply chain support, allowing ATMP developers to move therapies more efficiently between research sites, manufacturing facilities, and global clinical trial locations.
Strengthening ATMP Supply Chains with Certainty
With more than 700 clinical trials supported globally and experience in over a dozen commercial ATMP launches, Cryoport Systems is committed to enabling faster, more reliable, and more compliant supply chain solutions for UK-based developers.
The Stevenage Global Supply Chain Hub is more than a logistics center, it is a critical asset for ATMP developers looking to scale operations, navigate regulatory complexity, and ensure the integrity of life-saving therapies from early-stage research to commercialization.
For developers seeking a seamless pathway to European markets, the right supply chain partner makes all the difference. Cryoport Systems provides the infrastructure, expertise, and regulatory support needed to protect your ATMP supply chain and Enable the Outcome™ every step of the way.