Pharma Logistics is a business that has allowed air cargo to reach a level of excellence, with the Covid pandemic as the ultimate litmus test. The rapid advent of cell & gene therapies, however, will demand even more far-reaching solutions says Frank Van Gelder (FVG), Secretary-General of Pharma.Aero. CargoForwader Global (CFG) spoke with the official in Brussels.
To prepare for these upcoming challenges, Pharma.Aero has recently initiated its Cell & Gene Therapy Project, referring to the terminology which is common in Europe. In the U.S., the term
ATPM (Advanced Therapy Medicinal Products) is used.
The aim of the project is to explore the particularities that have an impact on logistics, to broaden the current knowledge of this next generation healthcare market, and to offer a better understanding of its transportation requirements.
CFG: Mr Van Gelder, what is the main difference between CGT/ATPM and ‘common’ pharma logistics?
FVG: The main difference is that, instead of large mass production for therapies, you move to a more individual and tailored therapy product in which you either extract cells from the patient themself for the creation of their specific therapy to attack the disease - in most cases, cancer - or from a group of donors. Those cells are then multiplied for therapy creation. A classic example of the latter are stem cells extracted from umbilical cords. So, looking at the logistics factor, you are in a totally different ball game as we move literally into the cell physiology.
The clinical studies on CGT/ATPM for life-threatening diseases, are gradually stimulating the development of this therapy. Some trials are underway and certain companies are heavily investing in them, with steep growth patterns in the U.S., Asia, and Europe. What is becoming clear, is that the complexity of the logistics chain is changing dramatically. You have to start with extracting cells from the patient or donor: there are extreme differences in temperature ranges for one therapy as these cells need conditioning – we’re talking about temperatures of up to -80°C to -196°C, and then there is adapted packaging.
After that, the cells must be sent to a production facility, from which they then need to be returned to the patient within a very short timeframe: a closed chain is therefore required. All of this will become a very serious challenge, since it involves very variable temperatures, from +37°C body temperature (when extracting the cells), to -196°C. The latter demands liquid (vaporized) nitrogen, which is nothing to drive around with on a systemic large-scale basis.
It will demand investments in an upgraded “no-failure” cool chain. Tomorrow’s innovative packaging will have to go hand in hand with the refrigerant, which has recently seen a revival of dry ice, as was proved by Pfizer Biontech, one of the largest Covid vaccine producers. The second investment will be in end-to-end visibility which will require enhanced digitization.
CFG: Would these investments weigh up to the modest volumes? Is this not merely a matter for integrators, rather than for the larger air cargo chain?
FVG: Volume becomes value. Shipments will become much smaller, specifically dedicated to one or a small group of patients, more complex and a lot more expensive. So, the investments will be partially reflected in the price. Today, no classical existing logistical model can respond to this challenge for a full 100%.
CFG: Not even Pharma CEIV-certificated companies?
FVG: This is rather a niche, which might put most companies off, but it will gain importance. Existing certification programs, such as CEIV, reflect the needs of the majority of shipments done today, but need detailed adaptation to these new healthcare treatments. With improving results, the social pressure to engage will become stronger. On top of this, 2023 is expected to bring a new wave of mergers and acquisitions in CGT/ATPM start-ups, feeding consolidation in the health care industry.
CFG: Where does Pharma.Aero fit in?
FVG: We advise greater leverage through increased knowledge of the product and its challenges. Very specific training and expertise to be able to respond to the demands of the logistics chain will be needed. Lead-times will be extremely important. You need far-reaching contingency planning for any disruption.
A mere Control Tower overseeing data will not be sufficient anymore, but rather a Command Tower will be the new normal. The mindset of the people involved is also very important. The shipments should be treated not unlike ‘Human organs for transplant.’
As standardization evolves, a new generation of digital technology will be required. It will be imperative to know the status of the shipment at all times, which involves the autonomy of the therapy package as well as continuous monitoring.
CFG: Given the limited timeframes and the complexity of the logistics, this does not seem to be much of an intercontinental business.
FVG: I also think it will be continental rather than intercontinental. Even so, we have to be ready. Belgium already has a lot of Life Science companies currently investing in this. Johnson & Johnson is investing in a CGT/ATPM plant in Ghent, and Bristol Meyers Squibb in Leiden in the Netherlands has another project taking shape, just to name 2 of the numerous projects currently taking off.
Belgium, and Brussels Airport in particular, is in the heart of the Benelux, Europe even. That means that we are going to accept and return a lot of samples. First and last miles will become important and need to be integrated in a healthcare logistics eco system. This will contribute further to the highly specialized pharma air cargo that Brussels Airport currently represents.
The difficulty is not only in loading and unloading these unique shipments on and from an aircraft. The crux of the matter is seamlessly linking all the stops, which brings us to another condition: multimodality and the role of the authorities such as Customs or healthcare departments. These consignments cannot afford any delay in their closed logistic circuit.
Bullet proof identification and thus labelling will be of utmost importance; specific coding will be necessary. Within the air cargo industry, we are in for extensive training, as we are not ready for this. You need to think in terms of fully integrated logistics.
CFG: So, you have to bring in the integrators after all?
FVG: To be honest, we will have to look beyond integrators. For the CGT supply chain to be successful, supply chain solution providers will have to work closely with hospitals and pharmaceutical manufacturing sites. Data will have to be shared along the value chain with zero room for failure. Understanding and trust are imperative. That is why we have decided to collaborate with the ATMP Logistics Excellence Centre here in Belgium.
Originated in Flanders, At.Las, a non-profit organization bringing together CGT stakeholders, has created this initiative to offer better understanding of these challenging products, and strengthen collaboration. That is exactly what is necessary. Collaboration beyond your own borders and cross fertilization of knowledge are the way. The cool chain, deep product knowledge, and the visibility related to it will also be important factors.
For the freight forwarders, data sharing will be imperative. It will be necessary to identify this data within the processes or to set up a separate process. That is why in Pharma.Aero, member companies such as Expeditors are strongly involved in our project.
Marcel Schoeters in Brussels
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