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Working with the latest technology to support your therapies
Failure within the supply chain can have the same impact on a patient’s treatment, cost of manufacture and reimbursement, as failure within the manufacturing process. Therefore, it is critical to have a robust logistics platform that supports critical shipments at clinical and commercial scales.
Our solution, World Courier’s Advanced Therapy Logistics Platform, is underpinned by a single global quality system and dedicated Customer Service teams, with offices in over 50 countries and an overarching knowledge gained from shipping to 2,000+ clinical sites annually.
Our global cryogenic charging locations
One solution to enabling viable donations and therapies to be transported over large distances is cryopreservation. World Courier has been managing the qualification, cleaning and transportation of cryo-shippers for over 20 years and has a global network of Charging Stations and Centers.
Advanced therapies are increasing the need for cryo-shipping, which in turn is driving technological innovation. To ensure that our customers can utilize the technology that best supports their logistics platforms, we have adopted and qualified multiple cryo-shipping systems.
Who we work with:
Packaging
The evo DV10 Smart Shipper, from Biolife Solutions, represents the best-in-class performance for cell and gene therapy logistics management. Designed to handle high-value payloads for long-haul international or bulk shipments, the performance is outstanding. With an internal temperature of ≤-180˚C, DV10 Smart Shipper can be upright or on its side during transportation without failure. DV10 is also the fastest LN2 charging unit on the market.
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The VIA Capsule is a unique cryo-shipper that removes LN2 from the supply chain. World Courier supported Cytiva in its development, providing our expert logistics, advice and infrastructure. We have brought a number of the cryo-coolers into our network – they charge and top-up the VIA Capsule in transit and ensure that the payload is maintained at the correct temperature.
This capability is enabled by the World Courier Quality EcoSystem that utilizes our single quality system to provide consistency and control throughout more than 140 offices. Through dedicated work instructions, the Quality EcoSystem supports thousands of miles of shipments and 13 of our offices, located throughout the global network, are accredited as Cytiva-approved charging stations.
Cryoport is dedicated to:
1. Simplifying global cold chain logistics through innovative technology, monitoring, data capture and support
2. Delivering the advanced temperature-controlled logistics solutions for the life sciences industry
3. Providing vital information that provides peace of mind throughout the life of each logistics process
World Courier
World Courier has been managing cryo-shipments for over 20 years and has established SOPs for the cleaning, qualification and use of dewars / dry-shippers. To support therapy developers, we have our own fleet of qualified dry shippers which are available on-demand throughout World Courier’s established global network.
Orchestration platforms
The development and delivery of advanced therapy solutions presents unique challenges for manufacturers and the supply chain. Maintaining chain of custody is critical to creating viable therapies, which means that orchestration platforms - whether sourced or developed internally - are essential to operating at scale.
World Courier has established systems for maintaining chain of custody whilst shipments are in transit, which includes real-time updates to stakeholders within the therapy developer, clinical sites and manufacturing facilities.
However, therapy developers also need to have sight of the entire vein-to-vein process. This visibility and control is provided by orchestration platforms. To help therapy developers quickly adopt these systems, World Courier has already integrated with multiple orchestration platforms, meaning we are connected and prepared to support your shipments.
Who we work with:
Orchestration Platforms
Chronicle
Chronicle automation software provides a unified digital platform to monitor your facility manufacturing operations and supply chain logistics. Electronic batch records trace every manufacturing step, and automation increases productivity. In addition, digitizing records reinforces GMP compliance and improves sample security. eSOPs manage deviations, promote adherence, and provide training. Chronicle has been independently audited against GAMP5, 21 CFR Part 11 and EU Annex 11.
TrakCel’s cloud-based software delivers personalized processes and workflows for every participant in the supply chain, allowing cell and gene therapy owners to safely manage and scale with confidence. Their fully-configurable platform efficiently and effectively orchestrates an advanced therapy supply chain – ensuring safe, scalable and affordable products. TrakCel delivers the visibility and control required to safely manage cell, gene and immunotherapies through clinical trials to a global commercial success.
In-house developed systems
For therapy developers who create their own orchestration platforms, World Courier has the experience and established APIs to manage integrations with these systems.
Consultancy
Advanced therapies present unique challenges across their entire supply chain, with each therapy requiring individual solutions for individual unit operations. This means that a change in any given area may impact on another, including the ability for the Logistics Platform to function.
‘Logistics by Design’ explains the value of developing manufacturing and logistics platforms in parallel. World Courier has partnered with GE and their ‘FlexFactory’ offering to enable therapy developers to gain value from our collective expertise.
We are also collaborating within the UK Advanced Therapy Treatment Centres (ATTCs) to design and create a seamless, vein-to-vein supply chain for advanced therapies.
Who we work with:
Consultancy
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Cytiva, a global provider of technologies and services that help advance and accelerate the development and manufacture of therapeutics, launches today. Previously GE Healthcare Life Sciences, Cytiva has nearly 7,000 employees and operations in 40 countries and is part of the Danaher Corporation Life Sciences platform.
World Courier has integrated with their orchestration platform, Chronicle, and collaborated on the development of the unique cryo-shipper, the VIA Capsule.
The Advanced Therapy Treatment Centers (ATTCs) Network Program is a world-first. It is a UK based system operating within the NHS framework, coordinated by the Cell and Gene Therapy Catapult that will address the unique and complex challenges of bringing pioneering advanced therapies to patients.
The ATTCs will work together with industry partners and the public sector to develop the necessary processes, skilled staff and infrastructure at scale.
