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Delivering personalised supply chains for autologous cell therapies

Customer: A clinical-stage biopharmaceutical company
Locations: To develop an end-to-end logistics solution for an autologous study
Challenge: Next Flight Out service with complete chain of custody and identity
Solution: US and Europe

Cell and gene therapies have the power to revolutionise treatment for many diseases. These advanced therapies are fragile, highly sensitive to the environment and are personalised to the individual. The ability to overcome these complex challenges is critical when managing cell and gene therapy supply chains.

Personalised medicine requires personalised transportation - an approach to logistics as revolutionary as the therapies it delivers.


Customer Overview

The customer, based in the United States, develops cell therapy platforms for a variety of solid tumors. Biocair was contacted to collect and transport the cells to the manufacturing site in Europe, and then ship them back to the patients.


Challenges

Ensuring chain of identity and custody

Given that cell and gene therapies are living drug products with complex demands, including short life spans and narrow treatment parameters, it was essential to provide real time information regarding a shipment’s location and condition, helping to ensure safe delivery of these critical materials.

cryogenic container

The need for contingency planning throughout

Delivering cells successfully can often be a complex, multi-step process. This particular application included a number of manufacturing and patient sites across a variety of locations globally.

Due to the complex nature of this study, and uncontrollable incidents that may arise such as the reduced flight options and changing flight schedules caused by the ongoing pandemic, Biocair’ s logistics experts had to mitigate potential issues, devising and monitoring alternate supply routes in advance of transportation.


Solution

Utilising the latest in temperature-controlled packaging and monitoring technologies

Taking into account the requirement to monitor location and condition in real-time, Biocair provided liquid nitrogen dewars with remote condition monitoring and GPS positioning. These state of the art dewars form a network of strategically located liquid nitrogen facilities worldwide.

Implementing a chain of custody and identity

Biocair managed chain of custody for each shipment, ensuring details such as the name of the driver, collection date and subsequent handovers were recorded throughout the study.

loading aircraft

24/7 support and project management by a team of industry experts

Biocair’s team of cell and gene therapy logistics experts provided around the clock support to the customer. During set up the team also arranged for on-site demonstrations and training, ensuring that each site was familiar in the handling of the study procedures, packaging and requirements.


Results

The team then monitored every shipment - checking location, orientation and temperature - and liaised with Biocair’s drivers for real time updates on progress to ensure absolute peace of mind of location and condition, guaranteeing the safe delivery of life-saving materials.

Speaking about this application, a customer spokesperson states:


"To maximise our ability to address the challenges surrounding the shipment of cells, we are working with Biocair as our shipping logistics and chain of custody partner. Biocair has reliably delivered these living products without diminishing their quality. We have benefited from the real-time tracking of shipments that Biocair provides."


female doctor

By implementing a collaborative approach working directly with key stakeholders, Biocair’s dedicated team of experts designed a personalised supply chain to support the development of the client’s innovative cell and gene therapies.

For more information about Biocair’s cell and gene therapy supply chain solutions, please contact your local office or email enquiries@biocair.com.