Whitepaper

Overcoming Cell and Gene Logistics Challenges

Updated April 2021

human-cells-whitepaper

With the expansion of cell and gene therapies, researchers increasingly require reliable logistical support with the safe and efficient transportation of products.

In the last five years, more than 1,000 clinical trials have used cell and gene therapies. Furthermore, over 500 cell and gene therapy candidates are being actively researched (1).

The cell and gene therapy sector delivers life-changing treatments for some of the world’s most severe conditions and diseases, relying upon a logistical supply chain that must perform to high clinical standards.

Building a supply chain to support a cell or gene therapy needs a clear understanding of many components. The therapy must be available when the patient requires their treatment, but doing this may also require swift, on-time delivery of starting materials to provide the manufacturing facility with the optimal product while meeting manufacturing run commitments.

Any erosion in the efficiency of the supply chain could have massive consequences for patients.

 

The challenges of cell and gene supply chains

Complex supply chains

It is not uncommon for cells to be collected from multiple sites, before delivery to the manufacturer, with the resulting therapy then returned to the patient. The challenge is to understand each component of this supply chain and its individual needs.

A patient’s apheresis collection may need refrigeration at between 2-8°C. Moreover, finished therapies may need liquid nitrogen shipment or dewars at cryogenic temperatures.

The logistical support needed is manifold and must integrate into a supply chain that can support the precise needs of cell and gene therapy.

End-to-end processes

Packaging requirements for cell and gene transportation require serious consideration.

With international shipping, it may not always be possible to obtain fast turnarounds (24 hours) between countries. The ability of the packaging to hold its temperature variance within stated tolerances can be challenging, especially when opposing climatic regions may need to be considered in a single shipment.

Logistical support service providers should be involved in the design of the end-to-end processes to support any variances in these clinical touchpoints.

Seeing the supply chain as a whole and not as individual components is vital. Making a change to one component can be counterproductive, as the knock-on effect of this modification has not been thoroughly tested.

Scaling up to manufacturing

As a therapy moves into the manufacturing stage, developers should consult with logistical support service suppliers regarding the location of manufacture sites. Co-location support may be required as the therapy rolls out to patients on a global scale.

Your logistics supplier can advise how fresh or frozen manufacturing may impact scheduling and delivery.

Contingency planning

Timely and reliable deliveries are critical components of the supply chain. A definite challenge for logistical support services is contingency planning. Communications when an incident occurs are critical to ensure contingency responses are implemented efficiently.

Gene therapies custom requirements may include new packaging innovations, new storage options, and validation of the cold supply chain.

This ensures the integrity of the therapy is maintained as it travels through the supply chain from the manufacturer to the clinician and, ultimately, their patients.

Summary

The growing cell and gene therapy sector will need comprehensive and integrated logistical support that is tailor-made for each therapy. The interdependences of each supply chain component must be clearly understood with appropriate contingency plans in place.

Ultimately, logistical support service providers must become more intimately involved with the clinicians, labs, and manufacturers they are serving. This will help them design the logistical support they need to deliver the therapies or patient care they are developing.

 

References

Data from www.researchandmarkets.com

Written by Biocair. Article originally published in Pharmaceutical Manufacturing and Packing Sourcer  © Samedan Ltd.

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