The information you provide to the chat will be collected and recorded to improve your experience and for quality assurance. Please read our privacy policy to see how we are storing and protecting your data.
How can we help you today?

The critical role of cold chain logistics: Safeguarding drug integrity from lab to patient

January 15, 2025 (12 minute read)

Category | Large molecule


Before the COVID-19 pandemic, many people weren’t aware of the critical role cold chain logistics played, particularly for temperature-sensitive biopharmaceuticals. This changed when the media highlighted the complex logistics involved in transporting mRNA-based vaccines, which required ultracold supply chain solutions to preserve their safety and efficacy as they traversed the world on their way to patients in need. These discussions underscored how important temperature control is for preserving the integrity of these products.

As the demand for temperature-sensitive therapies rises, robust cold chain logistics have become essential to ensuring product safety and efficacy. Even brief temperature deviations can compromise these drugs, leading to costly recalls, wasted resources, and risks to patient safety. According to the World Health Organization (WHO), nearly 50% of vaccines are wasted annually due to improper temperature management. Further, the global cost of pharmaceutical cold chain failures is estimated at $35 billion annually.

Cold chain logistics process for preserving biopharmaceutical drug integrity

The science behind temperature sensitivity

Large molecule drugs, such as monoclonal antibodies (mAbs), are highly sensitive to temperature fluctuations. Unlike small molecule drugs, which are generally stable at room temperature, large molecules are more susceptible to structural changes and chemical modifications—such as denaturation or aggregation—which can compromise their effectiveness. For this reason, consistent temperature control throughout manufacturing, storage, and transportation is essential.

Even small temperature fluctuations can negatively impact the stability of these drugs. Excess heat can cause a biologic to lose its ability to bind to its target, while freezing may cause ice crystals to form, damaging the drug’s molecular structure. Robust temperature control systems help prevent these issues and preserve the safety and efficacy of the product. If temperature integrity is compromised at any point, the drug can become ineffective, posing a significant risk to patients.

Cold and ultracold supply chain types

The cold and ultracold supply chain is typically divided into three categories, or “types”—refrigerated, frozen, and cryogenic—each designed to protect drugs at different temperature ranges, as described below.

  • Refrigerated: Many drugs, such as vaccines and monoclonal antibodies, need to stay between 2°C and 8°C (36°F to 46°F) to maintain their efficacy. Any temperature fluctuation outside this range could cause issues.

  • Frozen: Some drugs require storage below 0°C (32°F), typically between -20°C and -80°C (-4°F to -112°F). Even small changes in temperature can compromise the drug’s integrity, so careful and consistent monitoring is critical.

  • Cryogenic: Other drugs, like certain cell and gene therapies, need extremely low temperatures—usually below -150°C (-238°F). To keep them stable, they’re stored using liquid nitrogen in specialized containers.

Key challenges in cold and ultracold supply chain logistics

Cold and ultracold supply chains can be difficult for drug sponsors to manage, particularly when they have other development priorities to deal with. Beyond the obvious issue of temperature control during production, storage, and distribution, additional challenges include:

  • Regulatory compliance: Navigating different rules across countries can be challenging. Regulations can change frequently, and drug developers need to stay on top of these to ensure the safety and efficacy of their products in global markets.

  • Logistical hurdles: Cold chain transport usually involves a mix of air, sea, and ground travel, with many handlers along the way. Delays or changes at any point can jeopardize product quality, making real-time monitoring and close coordination key.

  • Cost and infrastructure: Cold and ultracold storage often requires expensive, specialized equipment. Maintaining this infrastructure can be particularly difficult in remote or underdeveloped regions, which can strain already tight resources.

Innovations and solutions in cold chain logistics

Recent advancements in cold and ultracold supply chain logistics have made it easier to maintain the temperatures required for sensitive biopharma products. Technologies such as in-transit temperature monitoring and reporting systems enable continuous tracking of critical shipments in one centralized platform, allowing real-time visibility into delays or excursions and supporting data-driven decision-making. Smart sensors provide another layer of security, detecting potential temperature fluctuations early and enabling quick action to prevent product damage.

Applying best practices in packaging and labeling further strengthens cold chain management. For instance, ensuring the right-first-time packaging and labeling of biopharma products at ultracold temperatures with zero time out of environment (TOE) is essential. Additionally, labels must adhere reliably in these conditions—an ongoing challenge in the biopharma industry, where proper labeling is critical for compliance. Managing cold chain logistics goes beyond just fridges and freezers; it involves a comprehensive suite of services and solutions to safeguard medical materials.

Partnering for cold and ultracold supply chain management

The reputation of biotechnology and pharmaceutical drug developers hinges on the ability to deliver safe and effective temperature-sensitive products to patients. But thankfully, they don’t have to tackle this challenge alone—expert support from experienced third-party partners is available. By leveraging these strategic industry partnerships, drug sponsors can mitigate risks and ensure their biopharmaceutical products remain safe and effective while en route to patients in need.

Thermo Fisher Scientific offers integrated CDMO and CRO solutions to support cold chain management, ensuring temperature-sensitive therapies are handled with care. Collaboration with logistics providers, technology experts, and regulatory professionals creates a seamless global network of facilities designed to meet every client’s needs. This approach, along with biorepository services for long-term sample storage, helps safeguard drug integrity from lab to patient.

To explore how Thermo Fisher Scientific’s comprehensive cold chain services help support the success of clinical trials, download our infographic.