When Disaster Strikes

Natural and man-made disasters are increasing in intensity. In the pharmaceutical and biotech industries, ensuring product integrity and availability is non-negotiable. Materials such as vaccines, biologics, cell banks, and other sensitive products require precisely managed storage conditions – because even a brief disruption to the supply chain can have significant consequences. 

In a recent Alcami study, many pharma researchers and drug developers expressed little to no interest in outsourced storage, with just two percent seeking an immediate solution within the next 3-6 months. However, this finding was in contrast with another part of the survey, where the top three most important reasons for seeking outsourced storage were cited as: “additional space, regulatory expertise, and assistance with emergency situations.”

There is an awareness of the need to plan for emergencies by seeking outsourced storage solutions and regulatory expertise, but many companies are not prioritizing or are only in the preliminary stages of considering backup or alternative options.

This disconnect can lead to a potentially dangerous situation, as disasters, by nature, arrive unannounced. For example, hospital systems across the US recently experienced an unprecedented shortage of IV fluid supplies when the sole manufacturing facility making 60 percent of the national supply was taken offline by massive, hurricane-induced flooding.

So, where do you start? How do you plan for the unforeseen? Laurent Boer, President, and Mike D'Avanzo, Associate Director, Pharma Storage, both at Alcami, discuss the challenges.

Are there any specific natural or man-made disasters you have observed in recent years that have had – or potentially could have had – an impact on pharmaceutical companies?
 

Mike D'Avanzo (MD): The first incident that comes to mind was all over the news in June 2023; Rensselaer Polytechnic Institute lost decades of “groundbreaking” research materials after a third-party cleaning custodian shut off a lab freezer because of an annoying beeping sound. This unfortunate incident highlights the devastating consequences of a single oversight, compounded by a lack of proper training, and safeguards, and underscores the need for robust contingency planning in facilities handling irreplaceable research.

Having a backup storage system, such as an additional freezer at another location or an emergency power system with redundant freezers, can safeguard against such catastrophic losses. A backup would have enabled the research team to transfer the sensitive samples immediately upon detecting the initial alarm, minimizing risk. Furthermore, improved protocols for critical equipment maintenance, including communication with non-lab staff, might have prevented the misunderstanding that led to the freezer being powered off in the first place.

Another key case of a pharma disaster involved decades of leukemia research samples destroyed after a freezer malfunction at the Karolinska Institutet in Sweden. The cryogenic samples were estimated to be worth millions of US dollars. The malfunction occurred in the supply of liquid nitrogen to the tanks, causing the tanks to go days without a fill. It was a devastating loss for leukemia research. The setback erased years of progress and potential future breakthroughs.

Redundant storage at separate locations and backup monitoring systems could have mitigated the damage by preserving duplicates and ensuring timely intervention.

Is there a degree of complacency among pharma manufacturers when it comes to disasters?
 

MD: Most people don’t expect a tornado to hit their manufacturing plant, but I think a lack of understanding of the potential risks and the impact on a business is a more prevalent theme than complacency. No matter where you are, there are always risks and potential disasters that must be evaluated and mitigated against. The type of disaster and potential impact will vary regionally, which further highlights the importance of strategic regional risk mitigation planning.  

Laurent Boer (LB): There is a level of acceptance that creeps into supply chain decision making after a crisis, such as Iceland’s Grimsvotn volcano eruption interrupting US-EU air traffic in 2011, or COVID-19 related supply shortages. Over time, cost decisions can impact carefully designed and implemented supply risk mitigations. Single points of failure in infrastructure and materials purchasing are insufficiently understood and mitigation strategies are often not effectively deployed.  

How can pharmaceutical companies balance cost-efficiency with the need for comprehensive disaster preparedness?
 

MD: This comes down to companies having a strong understanding of their supply chain and the potential impact that any disruption can have. Building out redundancies and measures for disaster mitigation can be costly and time consuming, which is why many companies deploy an outsourced vendor support program.  

LB: Risk mitigation starts with an understanding of the criticality of the materials and services in your supply chain, and the internal/external exposures of the supply chain. A cell bank storage risk mitigation is likely to look different than the risk mitigation strategy for clean room supplies.

In your experience, how receptive is executive leadership to investing in disaster preparedness?
 

LB: Any executive that has lived through a supply chain crisis understands the need for preparedness. Nevertheless, not everyone has the same risk tolerance or exposure to risk. Supply chains may look similar, but they’re rarely identical. Therefore, customized risk mitigation solutions and risk preparedness must start at the executive level.  

MD: It’s really about the value proposition and proving that the cost of investment justifies the return. An executive’s goal is to ensure that their business is resilient in the face of challenges. It’s up to area owners to exhaust all options when it comes to building disaster preparedness plans, understanding costs, and providing alternative solutions to achieve the same result.  

In the era of climate change, global tensions, and increasing disasters, what do modern, fit-for-purpose disaster mitigations plans need to consider?
 

LB: Plan ahead! Don’t wait until disaster strikes to consider your storage plan. Selecting a disaster-prepared pharma storage provider means prioritizing safety, security, and peace of mind. By focusing on redundancy, real-time monitoring, robust security, and proactive response protocols, you can minimize risks and ensure the safety and stability of critical materials.   

When evaluating potential outsourced storage partners, look for those who actively listen to your questions and concerns, and demonstrate a commitment to excellence through consistent audits and transparent reporting. Disaster preparedness is not just a “nice to have” — it’s a critical component of safeguarding the future of lifesaving treatments and innovations.   

Global markets, global supply chains, offshoring, near-shoring and on-shoring are under constant pressure of policy changes. The BIOSECURE Act is an example of changes in policy that can alter the risk profile in supply chains.  

MD: Best practices include preparing for both predictable and unexpected scenarios. Storage providers should simulate disaster scenarios, such as power outages or extreme weather, to ensure all systems and protocols function as intended. This extends to maintaining environmental controls in common areas, optimizing packaging for transportation, and continuously improving processes based on client feedback and technological advancements.   

Disaster mitigation planning must always consider natural events such as earthquakes, fires, floods, etc. In recent years, cyber security has also emerged as a prevalent and damaging threat that must be considered in mitigation planning.  

What must we learn from recent disasters?
 

MD: Unfortunately, many of the recent disasters we have seen in the industry were preventable and occurred because of a lack of control, planning, or expertise.  

LB: Every disaster is a use-case by itself. If we can learn something from recent disasters, it is that Business Continuity Plans (BCP) should always be under revision to protect the business and clients (patients), and ensure a controlled response to any disaster event.  

The basis of each BCP should include an incident control program that adequately responds to the immediate situation. Containment of the negative impacts provides the outline of the corrective actions. Organizations should mobilize their best supply chain and quality teams to define a comprehensive path forward.  

Pharma supply chains are global, with many different partners involved. What do pharma companies need to look for in their partners to ensure their supply chains are in good hands?
 

LB: The immediate logical question is to challenge prospective partners to demonstrate redundancy and resilience as expressed through the BCP and risk assessments. The same care you instilled in your supply chain should be expected with any potential partner.  

Are there certain regions/locations that are perhaps “safer” for facilities, partners, or storage locations?
 

LB: “Safe” is a relative word in this context. Storage in the US might be “safer” than other regions in the world undergoing conflict, but not every location in the US has the same safety profile from weather, or internal risks. A good recommendation is to avoid single geographic points of failure for critical materials. Every solution should be designed with redundancy to eliminate single points of failure against the risk that is the focus of the mitigation.  

In what ways could the pharmaceutical industry better collaborate to enhance collective resilience against large-scale disasters?
 

MD: Improving industry resilience against large-scale disasters is a complex issue. By diversifying storage locations and reducing single points of failure, companies can better manage risks for all. It’s also important for everyone in the supply chain — storage providers, manufacturers, and transporters — to align on disaster preparedness and have shared response plans in place. Clear communication and collaboration, especially when disaster strikes, can also help speed recovery. Investing in joint risk assessments and BCPs can ensure critical products are protected and supply chains stay stable, even during unexpected events.