Cross-Border Blood Flows

November 23rd, 2012 - For the past four years, a French biopharmaceutical company has shipped blood plasma donated by volunteers in Brazil to its plants in France.

There, the plasma is transformed through a process called plasma fractionation into medicinal products, including blood-clotting medicines and intravenous immunoglobulin.

Five months later, these medicinal products are flown back to Brazil and administered to hospital patients including burn victims or people with hemophilia and autoimmune diseases.

«This is a rare example of one country letting another country use its plasma for pharmaceutical purposes,» says Brice Bellin, healthcare product and development manager for SDV in Paris that manages the shipments. « Not many governments will give their authorization for these kinds of deals in such a protected industry. »

The Brazilian Ministry of Health signed a so-called fractionation contract with the French company because it wants to gain valuable know-how that will eventually allow it to become self-sufficient in blood derivatives.

Under the terms of the contract, the French company will transfer technology to Brazil that will lead to the construction of a fractionation plant there. This plant will be built over the next five years and is expected to meet between 20 percent and 100 percent of the needs of Brazilian patients in plasma-derived medicinal products, depending on the products.

The agreement illustrates the complexities and high stakes of the global blood plasma industry. Each monthly plasma shipment from Brazil fills a forty-foot container and is worth around 600,000 euros according to Bellin’s estimates.

The 52 palettes of plasma derivatives flown back to Brazil, meanwhile, are worth over double that amount, he adds.

Transporting blood and its derivatives requires special expertise and strict controls. The plasma shipped from Brazil to France is frozen at -30°C and transported in special refrigerated containers called reefers.

Security is vital, Bellin notes, because of the need to maintain the temperature during the 20 days it takes to ship the plasma from Sao Paolo, Brazil to Paris, France.

«We must plan for everything that can happen to the goods, » says Bellin. « If the container falls from the crane during loading, for example, we must make sure the temperature sensors are still working. »

The plasma-derived products sent back to Brazil by air must be kept at a temperature of between two and 25 degrees Celsius. They are also sent in special, temperature-controlled containers, called envirotainers, and packed in dry ice. The sensors record the temperature within the container every 15 minutes.

The deliveries are urgent. The dry ice melts after between 70 and 96 hours, putting fragile medicines in peril in the case of delays. This particular shipment flies from Paris to Brasilia, the capital of Brazil, via another European city and so new dry ice can be added if necessary at the stopover, Bellin says. It takes between five and six days on average to fly the medicines from France to Brazil.

Companies must also navigate the strict regulations for importers and exporters of blood. In Brazil, the slightest errors in import procedures can cause costly delays and fines. « Companies face tough penalties even if the goods are three kilos less than declared, » warns Bellin.

French customs procedures, meanwhile, must be carried out in the closest customs office to the place of final delivery, he adds.

The European and Brazilian regulations governing the transport of human plasma look set to become more complex, Bellin notes, making comprehensive protocols between the logistics provider and the client essential. These protocols should detail all areas of responsibility including warehousing, temperature control, journey times, customs formalities and document preparation. “We need to prepare for all eventualities,” he says.


Managing the challenge of transporting high-value blood plasma at a time of rising regulatory scrutiny.

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