Transplant Shipping for Gamida Cell with Medical Couriers
Transplant shipping is a key operation within Cell & Gene Therapy (CGT) operations. At Royale International, we specialise in temperature-controlled logistics services, exemplified by our collaboration with Gamida Cell for the transportation of OMISIRGE® (omidubicel-onlv), a nicotinamide modified allogeneic hematopoietic progenitor cell therapy. Through advanced logistics solutions and strong partnerships, we ensure these vital treatments reach their destinations safely, supporting successful transplant outcomes.
What makes an Omisirge shipment valuable for Transplant Shipping?
The handcarry shipments we manage for Gamida Cell are not standard cargo, rather, they represent personalised, life-saving treatments. One such product, Omisirge, is a cell therapy derived from human umbilical cord blood. This innovative therapy involves ex vivo cell cultivation over a defined period prior to cryopreservation. Each shipment of Omisirge consisted of two distinct packaging solutions, each with specific temperature requirements:
- A cryoshipper containing the cellular product, which must be maintained at a controlled temperature of -196°C or below in liquid nitrogen, and
- A CoolGuard Advance package containing an infusion solution, which is kept at a temperature range of +2°C to +8°C or controlled
–room temperature.
Given that Omisirge is a living cellular therapy intended for specific patients, maintaining the integrity of each shipment is critical. Deviation in temperature or mishandling would compromise the cells, rendering the therapy unusable. Thus, these shipments demand the highest levels of care and expertise within the logistics industry, particularly in the realm of transplant shipping.
What challenges are involved in transplant shipping for living cell therapies?
Handling the shipment request brought with it several challenges that needed to be addressed before it could be safely delivered:
- Temperature Control: The primary challenge is ensuring that the two different temperature requirements are maintained throughout the entire journey. Our team utilised specialised packaging and optimal routes to minimise transit time and avoid delays, which were crucial for timely transplant shipping.
- Transport Restrictions: Transporting a liquid nitrogen container in a plane cabin brought significant difficulties. Many airlines prohibit this, and airport security typically requires X-raying or opening all packages. For Omisirge, such actions would destroy the cells. We had to secure special permissions from airlines and the security department at the origin airport to bypass these standard checks.
- Timely Delivery: The success of the transplant depends on the prompt and reliable delivery of the product. This necessitates identifying optimal flights from its origin to its destination, prioritising direct routes to minimise delays and temperature incursions during layovers.
How did Royale succeed in transplant shipping for Gamida Cell’s products?
To address these challenges, we leveraged Royale’s extensive history of temperature-controlled shipment handling, a Dedicated Account Management structure, and a global network of certified On-Board Couriers (OBCs).
- Royale’s 30+ years of logistics experience prepared our Industry Experts to employ validated equipment that could handle the different temperature ranges. Under our global Quality Management System (QMS), these packages are pre-conditioned in our pharma hubs before loading any product and securing proper temperature control protocols.
- Each medical courier undergoes training on Gamida Cell’s specific procedures, ensuring dedicated shipment handling. This guarantees shipment integrity from the moment of collection until it is dropped off at the transplant centre.
- Moreover, our strong relationships with El Al Airlines and various airport authorities served as a key differentiator in our operations. We have successfully secured approvals to transport the cryoshipper in the cabin via documentation and customs support, allowing us to bypass standard security measures such as X-ray scanning and physical package inspections. This capability is essential for ensuring the success of transplant shipping.
Personalised transplant shipping is essential for delivering life-saving therapies like Omisirge to patients in need. At Royale International, our focus on meticulous planning, specialised packaging, and dedicated On-Board Couriers ensures the integrity of these critical products. Our partnership with Gamida Cell highlights how strategic logistics solutions can enhance patient care and contribute to successful transplant outcomes.
Learn more about the value of Royale’s bio-logistics solutions. Read through our previous article.
Need secure and tailored shipping solutions for your next CGT shipments? Speak with our Industry Experts at lifesciences@royaleinternational.com
About Royale International Life Sciences
Royale International specialises in shipping high-value, temperature-controlled products. Our commitment to excellence is reflected in our quality-driven and compliant logistics procedures throughout every shipment. The Life Sciences Division manages a wide range of biological shipments across various sectors. These include CGT, R&D, pre-clinical and clinical trials, laboratory logistics, pharmaceuticals, and biotechnology. Our Industry Experts provide tailored logistics solutions through dedicated On-Board Couriers and Express Air Freight services. Royale’s bio-logistics are accredited under our global Quality Management System (QMS) with validated equipment, trained professionals, and standardised operating procedures. All our processes are accredited by GDP, ISO, and IATA guidelines, ensuring shipments arrive safely, at the right place, at the right time