Cold Chain Readiness in the Era of Biologics and Advanced Therapies

Published August 2026 | Author: Leading Minds Network 

Key Takeaways 

• Cold chain readiness now begins with the patient. For biologics and advanced therapies, protecting therapies may represent a patient’s final treatment option.
• Ultra-cold and cryogenic requirements change the operating model. Requiring more capacity, more redundancy, more specialized partners, and tighter control.
• Visibility and contingency planning are mission critical. Weather, flight delays, manufacturing timing, and treatment windows require proactive decision-making.
• Suppliers and logistics partners are extensions of the organization. Qualification, scorecards, backup vendors, and continuous oversight are essential.
• The future will be more connected, but still specialized. Advanced therapy infrastructure will be widely accessible as treatments move closer to patients.
  
  

At first glance, cold chain logistics can seem like a matter of temperature ranges, validated packaging, and distribution routes. But as Henry Moran, Director and COO of ASC Associates, made clear during a recent Leading Minds Seminar in San Diego, the reality is far more complex. In a fireside chat with Chris Armstrong, Vice President and General Manager of McKesson Third Party Logistics, and Derek Truninger, General Manager of San Diego Clinical Services at PCI Pharma Services, the conversation quickly moved beyond equipment and process into something more urgent: patient impact.

The session, titled “Cold Chain Readiness in the Era of Biologics and Advanced Therapies,” explored how biologics, mRNA products, and especially cell and gene therapies are reshaping pharmaceutical supply chains. The discussion framed logistics as a frontline component of healthcare delivery.

Participants agreed that cold chain readiness starts with a simple principle: everything begins with the patient. That means ensuring that therapies are maintained within required conditions from the moment they enter the network until they reach the point of care.

What may have been acceptable 10 or 15 years ago is no longer sufficient. Customers, manufacturers, and patients are demanding more visibility and more assurance.

Truninger echoed that theme from the clinical services and packaging side. For PCI, readiness is about minimizing risk. That often means setting internal processes tighter than the minimum allowances provided by standards such as USP guidance. A stricter internal alarm threshold may create occasional false alarms, but it also gives clients confidence that even when an event occurs, the product may remain within acceptable scientific and regulatory boundaries.

One reality became clear during the discussion: the colder the product, the harder it becomes to replace, and the higher the stakes become. 

A New Operating Model for Advanced Therapies

The rise of cell and gene therapies has fundamentally changed cold chain assumptions. Traditional refrigerated products may move through established wholesale channels at scale. Advanced therapies, by contrast, often involve ultra-low or cryogenic temperatures, patient-specific timing, and highly coordinated treatment windows.

Truninger described the operational shift as a move toward speed, flexibility, and precision all at once. In vein-to-vein therapies, turnaround timelines may be as short as five days. That means procedures must satisfy quality expectations yet be flexible enough to support urgent clinical timelines. It also means vendors must be onboard before they are desperately needed.

Building cold chain capacity is never easy, because a refrigerator or distribution center is never big enough. But with advanced therapies, the industry has had to think differently. Organizations today invest in excess cryogenic capacity, not simply because demand exists today, but because future requirements are difficult to predict and each manufacturer may have nuanced handling requirements.

Some therapies may have exposure limits measured in seconds, with quality personnel literally using stopwatches to track time out of controlled storage.

Those requirements can be extraordinarily precise. For example, some therapies may have exposure limits measured in seconds, with quality personnel literally using stopwatches to track time out of controlled storage. That level of scrutiny is very different from conventional high-volume distribution—and it requires a different culture. 

Supplier Readiness: The Colder You Go, the Smaller the Pool

As Moran pushed the conversation toward supplier qualification, it became clear that advanced therapy logistics depends on specialized partners. Commodity packaging is widely available, but ultra-cold packaging, liquid nitrogen systems, cryogenic vessels, and white-glove courier services require smaller and more specialized supplier ecosystems.

Truninger described this as a delicate balance. Companies need access to best-in-class providers, but they also need qualified backups. Onboarding a secondary supplier requires time, validation, audits, and a willingness to manage risk before a crisis occurs.

The lesson was clear: to design these supply chains correctly, companies must understand what happens at the treatment site.

One practical example cited was to arrange onsite visits at hospitals, to directly observe how cell and gene therapies are handled close to the patient. These experiences can help to better inform equipment decisions and deepen vendor relationships.
 

Visibility Is Not Optional

One of the most memorable observations from the discussion compared pharmaceutical logistics to pizza delivery. Consumers can see exactly where a pizza is at every stage of its journey. Increasingly, healthcare providers and patients expect that same level of visibility for therapies that may be worth hundreds of thousands of dollars and, more importantly, may be life changing.

For advanced therapies, that gap is no longer tolerable. Treatment may be coordinated with surgery, specialized infusion, or a patient traveling hours to an academic medical center. If a flight is delayed or a weather event disrupts transit, stakeholders need to know quickly enough to adjust plans.

It was also noted that packaging durability has improved, with the industry moving from 24-hour pack-outs toward 48- or 72-hour solutions for many overnight shipments. But packaging alone is not enough.

Visibility technology, predictive tools, and better communication have become core elements of readiness.

The role of AI came up throughout the discussion. Participants spoke candidly that much of the industry still relies too heavily on retrospective analytics, and that there is a clear shift toward proactive risk management. Weather, route disruption, and shipment value all influence whether a shipment should move at all. All agreed that sometimes the right decision is not to ship a product worth hundreds of thousands of dollars into a known risk.

Truninger agreed that AI is coming but cautioned against using it simply to say it is being used. The real opportunity, he said, is turning data into a useful commodity: forecasting materials demand, identifying when smaller biotech clients may need to return to manufacturing, and integrating predictive tools in ways that genuinely improve decisions. 

Redundancy, Resilience, and the 10:30 p.m. Failure

If there was one operational mantra from the session, it was this: do not wait until failure happens to create the plan.

Freezers fail. Compressors fail. Power goes out. Shipments are delayed. All agreed that things rarely go wrong at “3:00 p.m. on a Tuesday.” They happen on Friday night, Saturday, or when the facility is least prepared.

That is why both organizations emphasized business continuity planning, backup generators, validated overflow capacity, preventive maintenance, and trained personnel. Truninger noted that PCI has invested in multiple storage ranges (i.e. controlled room temperature, refrigerated, frozen, ultra-low, and liquid nitrogen) while also evaluating aging equipment before it becomes a risk. Freezers may be expected to last, but they eventually need replacement.

During the session redundancy was framed as a philosophical shift. In traditional high-volume distribution, a company may not keep a massive empty refrigerator waiting for a catastrophe. But in ultra-low or cryogenic operations, maintaining spare capacity may be essential. If a freezer must be defrosted, serviced, or replaced, there must already be a place for the product to go.

Quality Culture Has to Reach the Floor

The panel also explored talent, training, and culture. Truninger emphasized removing tribal knowledge from the operation. Procedures must be clear, repeatable, and teachable. Cold chain execution should not depend on one person who “just knows” how something is done.

It was also emphasized during the session that there should be no single point of failure in talent any more than in process. Organizations need a bench of trained people who understand what to do, and why it matters. That knowledge becomes critical when events do not follow the script.

There was a consensus that recruitment and retention are inseparable from culture. Material handlers, warehouse staff, and operations teams are not peripheral to patient care. If they are not trained, supported and respected, shipments do not move. 

A Specialized Future, Closer to the Patient

For the foreseeable future, attendees agreed that advanced therapy cold chain infrastructure will remain specialized. Cryogenic handling, liquid nitrogen storage, ultra-cold packaging, and patient-specific distribution are not capabilities every site can or should maintain.

But access may broaden. Some speculated that more treatment locations may be established across the U.S., moving beyond large academic medical centers and major hospital systems.

The goal is to bring therapies closer to patients, even if the underlying logistics remain complex.

Truninger envisioned more hub-and-spoke models, with hospitals gaining improved cold storage capabilities but still relying on specialized networks.

The conclusion was clear: cold chain readiness in the era of biologics and advanced therapies is not a static capability. It is a mindset that is patient-centered, risk-aware, technology-enabled, and relentlessly prepared for the moment when something goes off plan.