Biocair recently spoke at two industry events, Gene Therapy Development & Manufacturing 2023 and On Helix 2023, where the company provided insight on how to mitigate risk in the cell and gene therapy supply chain.

Life science logistics requires complete visibility, expertise and reliability due to the sensitive nature of the time- and temperature-sensitive materials in transit. Biocair is a leading pharmaceutical, biotech and life science logistics provider with over 35 years of experience. Over the past couple of years, the business has invested heavily in cell and gene therapy logistics, ensuring potentially life-saving, personalised medicines reach the end patient in a secure and timely fashion.

The cell and gene therapy market is accelerating at pace, and is an extremely exciting area of science to be involved in. Due to the time-critical nature of personalised medicine, the sector needs logistics that deliver on-time, every time in perfect condition.

There are many risks to consider when transporting cell and gene therapies, including customs clearance issues, flight availability and temperature deviations.

Customs clearance issues
One of the greatest risks to time-sensitive cross-border shipments is customs clearance. In many cases, customs delays are due to incorrect shipment labelling and documentation. Regulatory changes happen on a frequent basis making it difficult for organisations across the life sciences industry to keep pace. Understanding when and if permits or licences are required along with the formal expectations of Importers of Record can take significant time away from core activities.

To tackle this challenge, it is best practice to follow these four steps:

• Treat each country individually. Customs formalities differ between countries. Even within the EU, it would be a mistake to assume countries operate under the same customs rules. Spain, Belgium and Italy, for example, operate differently from each other. Whether that be the information they require about the shipment, or the way in which that information is presented, it is crucial to know these differences in advance to ensure a quick customs clearance.
• Ensure proper classification and valuation methodology. Work with a specialist who can support with and verify material classification.
• Get destination preapproval. Does the partner receiving the shipment sign off on the paperwork prior to shipping? Do not begin to move the product without getting the ‘all clear’ from the destination.
• Partner with an expert. Work closely with an expert logistics provider for support with the nuances of customs rules in your shipping lane. Ask questions around the rules and barriers to trade.

Capacity and flight availability
Challenges with flight capacity and availability have been further exacerbated by the war in Ukraine and the lasting impacts of the COVID-19 pandemic. Fortunately, we are seeing an improvement in both capacity and flight availability. Still, it is crucial to choose a logistics partner who can manage this risk; who understands which airport gateways have the optimum flight options; who understands ground handling and makes sure the right logistics solutions are in place for specific requirements, such as ‘do not x-ray' controls.

Temperature deviations
Temperature control is a key consideration for those operating in life science logistics. For instance, many cell and gene therapies need to remain at cryogenic temperatures (-150 °C and below) to stay potent. When shipping materials across continents, it is critical to work with logistics specialists who understand the impacts any temperature deviations may have and are able to minimise the chance of them happening.

Expert support
Choose the right supply chain partner who understands the products, including their scientific value, and have a dedicated team on hand to help. This team will understand the sensitive nature of your shipments and the rules and requirements of the materials. Biocair now has a global team of cell and gene therapy logistics specialists, so customers can rest assured that their shipments are dealt with individually and all aspects of logistics are understood and managed with expertise and knowledge.

Tracking and visibility
Due to the nature of life science logistics, ensuring the right tracking and visibility of shipments throughout transit is necessary. This is why Biocair recently integrated with TrakCel, to improve automation and visibility in the cell and gene therapy supply chain.

To find out more about Biocair, experts in cell and gene therapy logistics and the perfect partner to help mitigate supply chain risks, visit www.biocair.com