Temperature-controlled CGT distribution
We offer a comprehensive range of temperature-controlled logistics solutions for cell and gene therapies (CGT) distribution. Our door-to-door solutions offer global provisioning of temperature-controlled active and passive packaging systems – from, -196°C to 2-8°C to 15-25°C, including conditioned vacuum insulated packaging (VIP) and rentals of fully charged dry vapor liquid nitrogen (LN2) shippers in various sizes to meet your specific needs.
Chain of custody and chain of identity for CGT
Whether you are moving apheresis to a manufacturing facility, autologous and allogeneic therapies to waiting patients, or a critical gene therapy for compassionate use—we ensure that the security and integrity of all your life science shipments are maintained from beginning to end. Our strict chain of custody and chain of identity procedures include individual tracking of unique IDs and other custom data, industry-leading quality assurance protocols and advanced temperature monitoring tools.
Clinical supply chain planning and execution for CGT
Having designed and implemented the clinical supply chains for the first FDA-approved cancer vaccine and the first two FDA-approved CAR-T therapies, our dedicated cell and gene therapy (CGT) experts are uniquely qualified to help design global supply chain models to your specific requirements.
Benefit from our experience. Having designed and implemented the clinical supply chains for the first FDA-approved cancer vaccine and the first two FDA-approved CAR-T therapies, our dedicated cell and gene therapy (CGT) experts are uniquely qualified to help design global supply chain models to fit your specific requirements.
Commercial Supply Chain Planning & Execution for CGT
When it comes to the commercialization of your therapy, speed to scale is vital to meet the global demand for treatments from patients expeditiously and efficiently. With proven experience helping the leading innovators in the CGT space design and implement a clinical-to-commercial scale supply chain, we are uniquely qualified to help bring your personalized medicine to market.
With a strict temperature profile, moving a cell bank can be complicated. Our seasoned experts work closely with you to develop a custom logistics plans to meet your unique needs.
Here are some of the features we offer:
QuickOnline is a market-leading online IT platform that easily integrates with orchestration platforms to help manage transportation costs, monitor packages with real-time information on the status of each shipment, and provide real-time data such as temperature, location, orientation, and light status.
Advanced monitoring systems that track real-time temperature, light sensitivity, and GPS location with automated alerts to avoid potential delays, providing an additional layer of security to any physical seals used to protect your critical shipments.
Cold chain manager technology that tracks, monitors and calculates the duration of transit against package validation time – allowing our logistics team to continually monitor and intervene if shipment integrity is at risk.
Dedicated, specially trained drivers with detailed route planning ensure the fastest and safest delivery any time of the day or night, with primary, secondary, tertiary, and quaternary routing options planned in advance for every contingency.
We offer end-to-end cold chain logistics services, including logistics planning and management, safe transport, and VIP temperature-controlled packaging and management, with around-the-clock access to our cold chain logistics experts and a network of strategically located and GDP qualified conditioning facilities for accelerated turnaround.
Expert temperature-controlled logistics for all temperature ranges, including cryofrozen, to meet the critical transit times and maintain the temperature of each cell bank shipment throughout transit to ensure the viability of CGT therapies.
A reusable shipper inventory management system for 15-25°C, 2-8°C, -20°C, and -40°C reusable shippers or our LN2 inventory, providing real-time status of units, conditioning, transport, tracking, return and qualification of dry shipper rental units for cost-effective, fast access, and download and transmission of data from the logger.
A robust chain of custody (CoC) ensures unmatched transparency of each apheresis, cell, gene, CAR-T or other personalized therapy shipment, providing the highest security and product integrity through individual handling of each patient specimen and CGT.
Track and monitor your cell bank shipments in real time: Individual tracking with unique ID number, detailed information, real-time GPS tracking, temperature monitoring, and automated alerts.
Ensure the safety and security of your cell bank shipments: In-transit storage (cold room) using GDP principles and best practices, LN2 provision and conditioning, optimized route planning, and point-by-point notifications.