Article: How to Ensure the Safety of a Cell and Gene Therapy Product During Shipping

By Simon Ellison |

Ensuring the safety and viability of cell and gene therapies during shipping

Cell and gene therapies (CGT) have the potential to change lives. These therapies, derived from live cells, aim to cure or significantly modify disease. However, the impact of X-ray radiation, used by airports to scan shipments, on these therapies and their donations is not fully understood and therefore a potential risk to their viability and function.

The safety of airlines and security of international borders is paramount, and places stringent requirements on shippers. World Courier therefore has systems in place that give security services the assurances they need, whilst supporting the shipment of viable therapies.

World Courier Regulatory Practices

World Courier has global systems in place to safely manage the transition of critical shipments through international customs, while giving customs agencies, airlines and security services the assurances and data they require.

While the exact processes differ depending on the shipment, we undertake a number of common actions:

  • Pre-screening through approved systems to negate the need for pre-carrier checks
  • Communication with airlines, brokers and customs in advance, to ensure a smooth passage through customs
  • Agreement in advance with relevant bodies on alternative screening methods and present as “known cargo”
  • Instructions and statement on the Master Air Way Bill confirming why shipments must not be irradiated
  • Alternate security methods using World Couriers extensive local experience/knowledge, and ability to utilize alternative means of screening, in compliance with local regulatory requirements

World Courier believe that the key to secure international CGT shipments is pre-preparation and traceability. This starts with a discussion between World Courier and the therapy developer to understand their shipping needs and the security implications, before completing all relevant paperwork and liaising with local teams in exporting and importing countries. It also requires advanced discussions with customs and security agencies to understand individual requirements. In transporting any shipment, we leverage the understanding and capability built over 50 years of innovation to deliver critical shipments on time and in full.

Once all preparation is complete an “OK to send’ authorization is given and the shipment starts - with complete oversight from a dedicated CGT customer service team where applicable.

Can your logistics partner meet the challenges?

When investing in global healthcare you need the highest level supply chain performance possible. Our goal at World Courier is to design the logistics platform which connects your therapy to patients. We do this through unsurpassed knowledge, global reach and flawless supply chain execution. Only with this can you ensure true peace of mind of your products and ultimately, your patients.

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About the Author

A portrait of Simon Eliison.

Simon Ellison

Cell and Gene Therapy Service Director from Sep ’17 – April ’20
World Courier
Simon Ellison, our Service Director for Cell and Gene Therapy, passed away in April 2020. Simon leaves a lasting legacy at World Courier and a distinctive mark on the advanced therapy logistics industry. His mission goes on with all of us to deliver cell and gene therapy treatments to patients in need.
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