The Power of the Cold Chain: Why Life Sciences Organisations Rely on it Today More Than Ever Before

JUNE 2021

The Power of the Cold Chain:

Why Life Sciences Organisations Rely on it Today More Than Ever Before White Paper

THE POWER OF THE COLD CHAIN: WHY LIFE SCIENCES ORGANISATIONS RELY ON IT TODAY MORE THAN EVER BEFORE

JUNE 2021

Introduction Today, life sciences products traverse the globe at speeds, and by modes and related supply chains, not conceived even a generation ago. Perhaps the most innovative among them all, given its increasing logistical challenges, is the cold chain. and power of today’s cold chain? Are you Are you deploying the latest cold chain technologies? Is your organisation relying on the best related logistics processes? Finally, are you working with the world’s best related infrastructure partners?

Executive Summary Global trade and logistics advancements have made the world a very small place for a very long time; however, time does not treat all cargo equally, not least perishable, and expensive life science products.

For this reason, the age-old cold chain – the temperature-controlled supply chain – must continue to innovate to survive and remain relevant in today’s world. Today’s COVID-19 vaccine demand, with its cold and ultra-cold shipment and storage requirements, continues to demonstrate just how critical the life sciences world continues to rely upon a global cold chain for the swift and secure movement of its goods.

Experts told us that life science organisations can today’s cold chain by actively changing the way they engage with their supply chain partners. They should be: - Deploying the latest cold chain technologies

About Our Research During June 2021, we conducted telephone and video call interviews with global cold chain experts who support the life sciences sector.

Our survey questions focused on the science, technology, and process that support the cold chain. We wanted to learn what cold chain professionals believed were evolving best-practices that organisations could implement to Finally, we wanted to learn whether there was power in partnership, i.e. excellence achieved when great companies come together to realise a common goal.

- Relying on the best related logistics processes - Working with the world’s best infrastructure partners

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THE POWER OF THE COLD CHAIN: WHY LIFE SCIENCES ORGANISATIONS RELY ON IT TODAY MORE THAN EVER BEFORE

JUNE 2021

PERISHABILITY SCIENCE: Understanding Shelf-life Will Lead All Improvements Survey any group of people anywhere in the world today, and they will be able to tell you with a fair degree of accuracy that most COVID-19 vaccines require cold- or ultra-cold storage and transport.

That fundamental understanding of perishability is the science behind the cold chain: that all shipments are temperature sensitive and subject to wastage if the appropriate range is not maintained.

What a majority of people do not fully understand, however, is just how complex cold chain science really is, and how quickly it continues to evolve. We found out from the experts with whom we spoke that cold chain science is the best possible starting point from which to hope to understand the cold chain phenomenon, and its critical role in supporting the growth of the global life sciences industry. temperature conditions ranging from 2 to 8°C, frozen (-20°C), deep frozen (-80°C) and cryo-frozen (-150°C). The safety and temperature regimen must be very, very strict. Temperature controls are less stringent for most therapeutics being used to treat COVID-19 in infected patients. The normal range for easily into the existing supply chain.

Said one global cold chain expert: “We have a situation where we have multiple vaccines, but each vaccine has its own temperature requirements. The another, and the shipping times and distances also often think there is one vaccine and one set of shipping parameters and temperatures. That’s not the case.

“Local language labelling and instructions will be a challenge. That’s not as simple as it sounds.

Labelling or adding expiration dates in local languages must be done according to GMP – the U.S. Food and Drug Administration’s Good Manufacturing Practices – and very few companies have GMP licenses in combination with a temperature-controlled warehouse. That gives you a feel for the complexity of this moment.”

Vaccines serve as an ideal illustration of today’s demand on the global cold chain as they usually have a short shelf life. Manufacturers produce doses, and they are shipped immediately. Vaccines are normally produced in batches of 100,000 to 150,000 doses – vials or syringes – a day. That sounds like a big number, but it is not when one considers the global need for up to eight billion doses, we learned.

“Initially, there was no one looking at long-term storage, but rather looking at cross-docking for quick onward movement. Normally, it would be 96 hours from factory to patient. Ninety-six hours might even have been long in the early going. Everything being produced was consumed right away. The vaccines in trials were used immediately. So, this product was not going to sit on the shelf for very long.” any healthcare industry cold chain is to understand the related products’ shelf lives and be able to cater to those increasingly rigorous temperature demands.

Only then can one begin to apply the best technologies to govern their storage and transportation.

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THE POWER OF THE COLD CHAIN: WHY LIFE SCIENCES ORGANISATIONS RELY ON IT TODAY MORE THAN EVER BEFORE

JUNE 2021

COLD CHAIN TECHNOLOGY: Investing in Digitisation is a Key Advancement in the Future The many and various technologies behind the global cold chain are both nearly a century old (think: dry ice) and leading-edge (think: blockchain). Yet what is clear in speaking with any cold chain expert is that a creative and complex combination of technologies will continue to be required to ensure shipment integrity from production to delivery. And, increasingly, digitisation – the need to reduce the human factor, the human handover – will be a key advancement in the future.

One such innovation is Abu Dhabi Ports’ proprietary custom-built digital system “mUnity” which ensures full vaccine visibility and tamper-proof distribution as part of its drive to deliver millions of COVID-19 vaccines around the world via the Abu Dhabi Government-led HOPE Consortium initiative.

Developed by its digital technologies subsidiary, Maqta Gateway, mUnity uses blockchain technology to track and trace COVID-19 vaccine sourcing, storage, shipment, and all related data in real-time at every step of the vaccine journey.

Being able to ensure that a shipment will remain safely within a temperature range for an extended length of time, beyond time spent at a manufacturing facility or dedicated cold storage facility, comes down largely to the type of container that is used and the refrigeration method. It is estimated that up to 20 percent of all energy consumed in cold chain logistics involves cargo refrigeration. We discovered that factors such as duration of transit, the size of the shipment, and outside temperatures experienced are important in deciding what type of packaging is required, as well as the related level of energy consumption. They can range from small, insulated boxes that require dry ice or gel packs, to a 50-plus foot “reefer” truck or van, which has its own powered refrigeration unit.

Perhaps one of the most exciting technological developments in the cold chain is the advancement of ‘active’ and ‘hybrid’ cold box containers which have become incredibly sophisticated, even in the last few years, thus enabling remote monitoring to vary temperature settings and prevent shipment wastage. “When you talk about moving doses in vials, you need to remember that you’ve got a very handling with more temperature-controlled packaging. Some are passive containers that are intended to preserve or maintain certain temperature

Va-Q-tec, Softbox and SkyCell are a few of these providers. Then you have active containers that can be programmed at a certain temperature, such as Envirotainer, DoKaSch, and CSafe. People do not want to take risks. So, the worry is that there could be a shortage of these temperature-controlled containers,” we were told.

Cold chain experts believe that, from a risk mitigation perspective, tracking and tracing and internet of things (IoT) will play an important technological contribution. It is vital that product security in ensured throughout the entire supply chain, not only in terms of establishing and using validated temperature-controlled transport and storage solutions, but also in terms of managing risks such as product integrity and risk of theft, since the vaccines are transported across the globe.

IoT are portable devices which connect and exchange data with other devices or systems over the Internet such as where it is and the condition it is in. The user decides what data from the device they wish to receive and can be proactively alerted in case of deviations. Improved data capture leads to fewer errors and fewer human interventions. With IoT, there is detailed visibility for each step in the supply chain Life science is fundamentally about the health of individual patients, so there are related requirements for serialisation – barcodes or QR codes for each individual product. There is a need to be able to scan there is full traceability. With these high-value goods, this is the rule rather than the exception. There is an understandable need to trace products all the way through the cold chain, from the factory into the patient, so the manufacturer knows which patient got what dose and from what batch.

“Because of the need to track every dose in a very secure way, this could be the moment when technologies such as blockchain prove themselves on a global level. So-called distributed ledger technology can help track doses, maintain quality control, prevent counterfeiting, and discourage theft,” said one of our expert respondents.

There is no question that the cold chain process functions best when it is as tightly integrated and secured as possible from end to end, from manufacturing down to the last mile.

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THE POWER OF THE COLD CHAIN: WHY LIFE SCIENCES ORGANISATIONS RELY ON IT TODAY MORE THAN EVER BEFORE

JUNE 2021

LOGISTICS PROCESSES: Owning the “Last Mile” is Critical Cold chain logistics are a constant challenge for the life sciences industry, with IQVIA’s Institute for Human Data Science estimating that the biopharma industry loses approximately USD 35 billion annually because of failures in temperature-controlled logistics, as temperature deviations from the required conditions are a major concern for manufacturers.

Research from the World Economic Forum has highlighted that more than 50 percent of all vaccines are wasted globally each year because of temperature control, logistics, and shipment-related issues.

Moving a shipment across the supply chain without requires the establishment of a comprehensive logistical process to maintain shipment integrity.

This process concerns several phases ranging delivery point.

The delivery stage of the cold chain is known in the industry as the “last mile.”

We found out from the experts with whom we spoke that this stage is the most important, as well as the most fraught with risk.

are not enough logistics providers with Good everybody can safely handle or distribute or collect vaccines, for example. There also are local disposal considerations where something might be spoiled or compromised, and then you have documentation and GDP-compliance issues,” we learned.

Life science organisations that want to ensure the integrity of their shipments must seek to own the “last mile” and do so by working with the best possible logistics partners they can.

With this in mind, the key attributes in protecting the - Partner selection – working with partners that have embedded quality programs and that have invested in quality training, processes and systems; - Technology adoption – ensuring that your selected technology has the ability to function regardless of terrain and infrastructure; and, -

the same; there is a need to implement a robust risk assessment program covering not only the partners’ assets but also the multiple touch points for technology as well as the routing to be used in

“The last mile is the weakest link. Localised distribution is problematic in countries where there

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THE POWER OF THE COLD CHAIN: WHY LIFE SCIENCES ORGANISATIONS RELY ON IT TODAY MORE THAN EVER BEFORE

JUNE 2021

INFRASTRUCTURE PARTNERS: Hubs Matter for Manufacturers In speaking with global cold chain experts from the life sciences industry, we discovered that there is competitive advantage to be gained for those organisations that seek out regional cold chain “hubs” where there are growing developments, in terms of new manufacturing and airside cold storage and distribution centres either being built or land being made available for their construction.

Abu Dhabi, Brussels, and Singapore were noted by our experts as cold chain hubs for the life science industry.

Abu Dhabi International Airport is unique with its dedicated pharma terminal, cool storage facilities, new cool dollies for airside transportation to thermal blankets, and cool bays with two temperature ranges. Abu Dhabi Ports’ Khalifa Industrial Zone Abu Dhabi (KIZAD) currently operates the region’s largest cold storage facility for COVID-19 vaccines.

“You see the whole life sciences industry at work

example, can be safely stored while they are awaiting onward transport or shipment to markets where they will be made available to the public.

One large parcel delivery company is opening temperature-controlled sites in Benelux countries and a massive site in the United States. We see other large shippers doing the same,” said one respondent.

With many life sciences products requiring a strict temperature regime, there exists an increasing demand in cold chain storage and shipping capabilities. Around the world, warehouse space is be an insatiable demand for cold storage space; it simply cannot be built fast enough.

For logistics providers, they ideally want cold-room capabilities near the airport, so they have easy access to uplift. Most doses of vaccines will be moved by air, and that is where constraints on cold storage and air freight capacity become concerns.

located cold chain facilities where vaccines, for

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THE POWER OF THE COLD CHAIN: WHY LIFE SCIENCES ORGANISATIONS RELY ON IT TODAY MORE THAN EVER BEFORE

JUNE 2021

CONCLUSION The life science industry’s reliance on the global cold chain continues to gain importance, thus it is critical that its leadership remain abreast of the constant changes taking place in the related areas of technology, logistics, and infrastructure development, among others.

The pharmaceutical manufacturing industry is heavily dependent on the controlled and uncompromised transfer of shipments along the cold chain, with many of these in the experimental or developmental phase.

Clinical research and trials are a major part of the industry that cost hundreds of millions of US dollars each year to companies and cannot ever be compromised in any way.

As one expert told us: “When we move life science containers, we believe we are moving patients’ lives, not simply products. That is how seriously we take our work, and that is how important each element of the cold chain must be considered from end-to-end, if we are to continue to innovate.”

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