Cold Comfort for Bio/Pharma

@skuder_photographer - Stock.adobe.com

The COVID-19 pandemic highlighted how vital cold chain is for the pharmaceutical industry, particularly as some vaccines needed to be produced, transported, and stored at –70 °C. Market projections for cold chain logistics of pharmaceuticals are projected to grow at a compound annual growth rate of 9.03% by 2025, which is reported to be driven by greater global demand for pharmaceuticals, increasing initiatives to promote cold chain, and more demand for reefer containers from the pharma industry (1).

To meet the increase in demand for temperature-controlled solutions, logistics providers are being required to adapt their approaches and employ more advanced technological solutions, while still adhering to strict regulatory requirements. Pharmaceutical Technology Europe spoke with Nick Gilmore, Global Head of Sales and Marketing, Tower Cold Chain, to learn more about how cold chain solutions have changed, what the regulatory landscape is looking like for logistics providers, and potential future trends for the sector.

Adapting to meet demand

PTE: How have cold chain solutions had to adapt to meet the growing demands for cold chain logistics?

Gilmore (Tower Cold Chain): Putting the European success of the COVID-19 vaccine rollout to one side, the demand for effective temperature-controlled packaging solutions in the pharmaceutical supply chain has increased significantly in recent years. Indeed, with a growing prominence for personalized medicines, we are now beginning to see the advancements of precision therapies in the pharmaceutical cold chain industry. There is no longer a ‘one-size-fits-all’ approach to medical intervention. Instead, we’re seeing a move towards bio-specific treatments, tailored to a particular individual’s needs based on their genome. And, with manufacturing adjusting to smaller batch, precision medicines, the vendors, and outsourcing partners must adapt too as the need for transparent, closely controlled global supply chains rise.

It is critical for pharmaceutical manufacturers to partner with a cold chain expert that is committed to continually expanding and evolving, to keep pace with the growth and complexities of transporting temperature-sensitive pharmaceuticals. Cold chain shipping providers should have the technology, resources, and network in place for handling lower volumes of products with tight manufacturing-to-patient timeframes. Delivering a consistent customer outcome, is a need not a want. Put simply, manufacturers will choose partners who offer both proximity and availability assuring products will arrive on time, undamaged, and with no temperature excursions.

Where historically pharmaceutical products were manufactured in one central factory, today they are more often produced, mixed, filled, and packaged in separate locations, thus demanding greater distribution and movement. It is no longer just about the final leg of the journey to patients. Logistic organizations who can offer customers a network of fully stocked hubs and service centres, located across multiple countries, can maximize their proximity and availability, and offer localized sourcing, will be in a strong position to become a partner of choice.

Factoring in the high value of pharmaceutical goods, their perishable nature, and susceptibility to temperature changes, manufacturers require not just optimized networking, but assurance of product integrity for patients and businesses alike. It is here that the choice of the most appropriate cold chain solution makes all the difference.

A data-driven world

PTE: As cold chain technologies advance to accommodate industry demands, are European regulations changing appropriately to address the novel technologies being used?

Gilmore (Tower Cold Chain): The pressure is on for logistics players, manufacturers, governments, and non-governmental organizations to improve their capabilities in supporting the life sciences industry, whilst adhering to standards enforced by regulatory bodies to ensure product quality and safety. One solution to meet this industry need is through digitalization.

The volatility of the pharmaceutical market combined with today’s increasingly connected, fast-paced, customer-focused world means data is no longer a bonus feature, but a vital part of cold chain operations. Smart packaging which delivers end-to-end traceability and precise shipment tracking is now a cornerstone of supply chain fulfilment.

Dataloggers, designed to monitor external and internal temperatures throughout the containers journey, can be built into containers, which is an aspect included in those provided by Tower. Using Bluetooth Low Energy Technology, each logger communicates wirelessly, sending real time, accurate data to the cloud. This data communication allows for in-transit compliance checks and on-delivery sign-off, establishing a complete electronic and hard-copy audit trail across the entire logistics process providing complete visibility and transparency to customers.

Assurance of product integrity is paramount in cold chain which is why reliability is a key foundation for logistics providers, such as Tower. Data downloaded from over 15,000 shipments demonstrates fewer than 0.1% of temperature excursions on average, a vital indicator in the maintenance of the cold chain.

Impact of sustainability goals

PTE: The European Commission is driving more ‘sustainability’ issues within its pharmaceutical strategy, how might/is this aspect impacting cold chain for pharmaceuticals in Europe? Are there similar demands for more sustainable solutions being demanded from countries outside the European Union too, such as the United Kingdom?

Gilmore (Tower Cold Chain): The EU’s pharmaceutical strategy (2) holds significant potential to drive sustainability in the pharmaceutical sector—and is an opportunity not to be missed. The strategy’s key goal is to reduce the impact of pharmaceutical substances on the environment and pave a way for the pharmaceutical industry to contribute to climate neutrality in the EU, with a focus on reducing greenhouse emissions along the value chain.

With such demand for greener supply chain management not just in the UK and EU but globally, many pharmaceutical organizations are reassessing their processes, seeking out external partners with sustainability-first mindsets. In line with government and consumer efforts to address single-use plastics, manufacturers have been compelled to look for sustainable packaging alternatives to ship products. As such, reusable cold storage containers are growing in reputation as a sustainable method for medical logistics. All players in the cold chain have a role to play in sustainability.

Post-Brexit considerations

PTE: After Brexit, are there any specific considerations that you must take into account for cold chain logistics across the continent now?

Gilmore (Tower Cold Chain): With post-Brexit consequences still impacting supply chain shortages and labour capacity, pharmaceutical logistics providers are focusing on developing strategic solutions to mitigate the effect of ongoing difficulties. For example, Tower is seeking to mitigate the potential impact of Brexit by expanding its international hub network, with service centres opening not just in Europe, but also throughout other global regions. By optimizing the global network for localized delivery, it is possible for logistics providers to react even more quickly to customer requests.

Reports of bounced loads by carriers are causing major disruptions in the logistics industry, with Brexit as its catalyst (3). Local customs procedures require the broker to move between local and national government customers offices and then to the Ministry of Health for approval before pharmaceutical products can be released for import. Add Brexit regulations into the mix, and the risk of delay has increased massively.

To alleviate the threat of temperature excursion, pharmaceutical organizations require temperature-controlled containers, robust enough to protect products, and reliable enough to reduce the risk of wastage. Passive containers are a beneficial solution to this demand as they can provide temperature consistency and external security for the product without the need of an external source of electricity or manual checks—passive systems operate using phase change materials, utilizing water, ice, or dry ice to maintain thermal accuracy.

Potential future trends

PTE: Could you provide your expert opinion on possible future trends that will be influential to cold chain logistics in Europe?

Gilmore (Tower Cold Chain): With its capital-intensive equipment, strict temperature requirements, and energy dependence, the cold chain has always been a demanding logistics segment. Today, the cold chain is grappling with additional challenges: serving a global market, driving out costs and waste, addressing capacity and resource constraints, and dealing with continually mounting regulations—all whilst handling valuable pharmaceutical cargo. It is vital that cold chain logistics service providers adapt and thrive, to futureproof themselves in an ever-complex industry.

An international market. With the amount of sensitive biopharmaceutical and biologic products expanding, coupled with the demand for advanced pharmaceuticals in middle to low-income countries, cold chains will continue to be pushed to globalize in the coming years. Pharmaceutical organizations are increasingly relying on their external suppliers to operate lean supply chains, with extended distances to ship products quickly and efficiently. Logistic providers must ensure these needs are met, offering a global network for localized deliveries—all whilst complying with each country’s regulations to maintain the strictest requirements.

Technological investment remains critical. Like all supply chains, cold chain operators must continually upgrade technology to ensure efficiency, integrity, and safety. Demand for increased visibility will drive cold chain third-party logistics to innovate and add value to services. Cold chain logistics providers must invest in the latest on-board equipment built into containers to track temperature and location, and to make data available to partners and customers in real time, to prevent or mitigate loss.

Digitalization and the Internet of Things, which are being assessed by Tower, can provide operators with the ability to work faster and better, through both automating and optimizing processes to provide the highest quality and consistency to customers. Systems are integral to the way cold chain operators work and these technologies will help to deliver new ‘SMART’ solutions to the market.

Competition continues to intensify. While the demand for cold chain logistics services is increasing, competition has also intensified. Providers are introducing new, innovative services or are upgrading existing solutions for cold chain logistics. As a result, there are more choices as well as more competition in the market.

Pharmaceutical organizations are also facing competition from generics and biosimilars (less expensive versions of biologics with expired patents). Whilst reliability is still the number one priority in cold chain services, there is an increased focus on cost-efficiency.

The total cost focus in the pharmaceutical industry, coupled with the increased competition and digital self-service means that customers have more choices when selecting solutions to meet their needs. Suppliers to the pharmaceutical sector must be proactive and continuously look to update their services to stay ahead.

The example of the last few years underlines how turbulent and fast changing the pharmaceutical supply chain can be. With demand set to increase further, this complexity isn’t going to go away. That’s why it’s vital to anchor cold chain decisions in the essential elements that won’t change.

References

1. Technavio, Cold Chain Logistics Market for Pharmaceuticals Industry by Service and Geography—Forecast and Analysis 2021–2025, Market Report (July 2021).
2. European Commission, “A Pharmaceutical Strategy for Europe,” Public Health Information, ec.europa.eu [Accessed 1 March 2022].
3. S. Clarke, “Road Freight Between Britain and EU is Down by a Third, Data Shows,” The Guardian, 31 Jan. 2021.

About the author

Felicity Thomas is the European editor for Pharmaceutical Technology Group.

Article details

Pharmaceutical Technology Europe
Vol. 34, No. 3
March 2022
Pages: 25–27

Citation

When referring to this article, please cite it as F. Thomas, “Cold Comfort for Bio/Pharma,” Pharmaceutical Technology Europe 34 (3) 2022.