There’s cool irony to the fact that, each year, some $35 billion in sophisticated, often lifesaving biopharmaceuticals and active pharmaceutical ingredients (APIs) go lost due to failings related to a technology that’s well over a century old: electric refrigeration.
To be fair, refrigeration is much harder to manage across a multimode pharmaceutical supply chain than it is in your kitchen. Biopharma cold chains must maintain prescribed temperatures from the manufacturer to the distribution center to the regional storage facility to the pharmacy, hospital, or clinic. Along the way, there are refrigerators in trucks, train cars, and aircraft – and, in some cases, on motor scooters and even drones.
Too often, the biopharma business has tried to manage the cold chain with combinations of in-house legacy systems and manual processes. Such approaches have little hope of providing real-time visibility into temperature, vibration, and other environmental factors across complex, multimode supply chains.
In 2025, life sciences companies are making strategic investments in areas like CDMO partnerships, end-to-end supply chain visibility, and generative while advancing personalized therapies and precision medicine.
In pharmaceutical logistics and distribution, the true challenge isn’t merely keeping products cold. It’s guaranteeing that every single vial, every individual dose, adheres to its precise temperature and time tolerances from production to patient.
Here’s the critical nuance: Biologics and vaccines don’t just require storage within a 2°C to 8°C range; they operate under a strict stability budget, a finite allowance for deviations. Surpass this window and the active ingredient gets worse. The therapeutic effect will weaken. Patient safety is balanced.
This isn’t theoretical. Every temperature excursion—whether during a tarmac delay in Dubai, a last-mile delivery in Lagos, or an inadvertent warehouse door breach in Chicago—consumes that stability budget. And unlike a financial ledger, this deficit can’t be reconciled. Once stability is compromised, there’s no undo button.
So the pivotal question shifts: It’s no longer “Can we keep it cold?” but “Can we prove with irrefutable data that every product delivered is as rigorously validated as its day of release?”
That’s the actual benchmark. And meeting it demands more than cold storage, it demands uncompromising precision.
Fortunately, management of biopharma cold chains has come a long way. Today’s approach involves integrating specialized cold-chain monitoring solutions with cloud-based ERP systems to provide immediate, comprehensive understanding of the status of the cold chain and the vital products whose efficacy depend on it.
Others, such as the Pfizer-BioNTech COVID-19 vaccine, need ultracold temperatures (-80C to -60C) or need to be frozen (-50C to -15C) until shortly before administration.
To further complicate matters, therapies such Humira, Avastin, insulin, and the hepatitis B and DTaP vaccines are also sensitive to vibration. And Enbrel, Keytruda, and the MMR and hepatitis B vaccines should not be frozen.
Cell and gene therapy tout promising results, but manufacturing challenges around personalized treatments require industry focus to meet the moment.
Yes, that’s a lot to track. But cloud-based integrated cold chain monitoring solutions with embedded RFID and internet-of-things (IoT) technologies can handle it. They define global manufacturing and supply chain nodes, establish stability matrices to predict the stability of temperature-sensitive products, and manage workflows for approval locally and globally.
These systems have shown to reduce product and API losses by roughly 20% while helping avoid expensive and labor-intensive recalls and returns. They ensure product integrity, preserve efficacy, and improve patient safety.
Forward-thinking companies that adopt integrated cold chain monitoring solutions don’t just future-proof their cold chains, they unlock a foundation for agentic AI to drive transformative efficiency.
Imagine a system where AI doesn’t just track temperature deviations, but autonomously reroutes shipments in real time, predicts freezer failures before they happen, or negotiates priority handling with logistics providers during delays. Imagine the significant productivity gains and potential cost savings associated with that.
This isn’t just digitization; it’s self-optimizing supply chain intelligence that turns risk mitigation into competitive advantage.
Managing a single refrigerator, no problem. Managing biopharma cold chains is a different story, and given the rapid pace of innovation in—and the therapeutic potential of—temperature-sensitive biologics, it’s only going to get harder.
Given the human and economic costs of product degradation and loss due to temperature excursions and other environmental hiccups along the supply chain, cold chain monitoring solutions have become indispensable to the biopharma business. That’s the cold truth.
Learn more about SAP + Infosys cold chain solutions HERE.
