Biocair is a leading pharmaceutical, biotech and life science logistics provider with more than 35 years of experience.
During the past couple of years, the business has invested heavily in cell and gene therapy logistics, ensuring that potentially lifesaving 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.
Owing 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
In many cases, customs delays occur because of incorrect shipment labelling and documentation. Regulatory changes happen on a frequent basis, making it difficult for life science organisations 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 that 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 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.”
- Tracking and visibility: Owing to the nature of life science logistics, ensuring the right tracking and visibility of shipments throughout transit is critical.
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 and 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
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 that 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. Ask questions about any barriers to trade and work closely with an experienced logistics provider for support with the nuances of customs rules in your shipping lane.
