APRIL 29, 2025
From Innovation to Action: What the ISTA Forum Revealed About Cold Chain’s Next Chapter
The Healthcare Distribution Association (HDA) hosted their annual TransPack | TempPack, attended by a lively audience of packaging engineers and pharma supply chain professionals. We are delighted ThermoSafe’s Ben Vanderplas sits on the ISTA Pharma Committee and two ISC Lab engineers, Md Abu Hasan and Saad Imran, gave a presentation about thermal modeling & AI, more on that below.
This blog post will review the outstanding highlights of the ISTA TempPack event that is created and led by industry professionals – so you know the topics are ‘on the ground’ relevant to pharma supply chain processionals, especially packaging engineers.
Hot Topics – Discussion Groups and Active Whitepapers
The ISTA Pharma Committee is in constant motion listening, dialoguing and creating best practice guides for their members and with industry.
During the event, there were several active whitepapers discussed, guided by insights from industry surveys, has identified three key topics as priorities for developing industry guidance. To address these, the committee has begun the development of white papers focused on
- Thermal Packaging Sustainability Considerations
- Frozen Product Considerations
- Temperature Monitoring and Real-Time Monitoring Considerations
Stay in touch with ISTA on the development of these important topics that are paving the path for industry best practices.
The Cold Chain Has Shifted, Again
Chris Anderson, Director, Quality Management at Cardinal Health delivered a global “Pharma Industry Update,” highlighting how regulations, product trends, and distribution models are reshaping the pharmaceutical cold chain.
To set the stage, he described how pharmaceutical sales have seen a 9.8% growth in 2024, while the top 5 products were Mounjaro, Ozempic, Zepbound, Wegovy, and Paxlovid.
What do these drugs have in common? = 4 out of 5 of them are 2–8 °C
Then he looked at the top 5 US mail order drugs: Humira, Stelara, Skyrizi, Dupivent, Enbrel.
What do these drugs have in common? = They are all temperature controlled as well!
Top 5 US Mail order drugs:
- Humira (2–8 °C)
- Stelara (2–8 °C)
- Skyrizi (20-25°C)
- Dupivent (2–8 °C)
- Enbrel (2–8 °C)
This shift toward DTP models, driven by patient convenience, telehealth, and specialty drug growth is accelerating demand for reliable cold chain packaging. Ensuring product integrity during last-mile delivery, often to unmonitored home environments, adds complexity and raises the bar for packaging performance. As a result, the pharmaceutical industry is seeing an expanded need for temperature-controlled packaging that is not only robust, but also tailored for smaller, more frequent shipments.
Cold chain becoming the norm: The rise of biologics means that temperature-controlled handling is no longer a niche issue – it’s mainstream. According to ASHP analyses, nearly half of new drugs approved in the last few years require cold storage.[1]
In fact, while less than 5% of patients use specialty medications, these drugs now account for over 50% of pharmaceutical spending.[2]
Most of these therapies require refrigerated (or even frozen) transport and storage. This shift toward complex, temperature-sensitive drugs means packaging engineers must treat cold chain capability as a standard design requirement. Everything from cell and gene therapies to weekly self-injection pens for chronic diseases, all need packaging that can reliably keep products in the 2–8 °C range.
Thermal Modeling / Simulation & AI
Thermal simulation has been a valuable tool in the cold chain industry for accelerating the design life cycle of thermal shippers and understanding the impact of various design parameters. With the growing emphasis on sustainability, the demand for optimized shipper solutions that minimize weight and components is higher than ever.
ThermoSafe ISC Lab engineers – Md Abu Hasan and Saad Imran co-presented on the topic of “Optimization of Shipper Design using Thermal Simulation and Artificial Intelligence/Machine Learning (AI/ML)”.
- Smarter shipper design: How to achieve design for efficiency in the age of AI
- AI Meets Engineering: Using machine learning to balance insulation, materials, and refrigerants with data-backed decisions
- Optimization: Real-world outcomes: cost savings, weight reduction, and sustainability gains
Hasan and Sadd will be digging into this topic again during an online event hosted by The Cold Chain Exchange. Join the live webinar to dig into this topic further REGISTER HERE.
Cell & Gene Therapy in Motion
The influx of cell and gene therapies (CGTs) is fundamentally transforming the pharmaceutical supply chain, particularly when it comes to storage, transport, and packaging. Unlike traditional pharmaceuticals, CGTs are often living therapies – highly sensitive to temperature fluctuations, mechanical stress, and time.
One of the ISTA sessions described how many CGTs require storage and transport at ultra-low temperatures, sometimes at -80°C or even cryogenic conditions below -150°C, to maintain their viability and therapeutic potential. This presents an entirely new set of logistical challenges, as even minor temperature excursions can result in loss of product integrity, posing a risk to patient outcomes.
As a result, the need for highly specialized, validated packaging solutions has surged. Packaging for CGTs must not only offer robust temperature control over extended durations but also be capable of protecting therapies through increasingly complex global distribution networks.
Traditional cold chain packaging is often insufficient for these extreme requirements. Instead, ultra-low temperature shippers, cryogenic dewars, and sophisticated monitoring devices have become essential to safeguard product quality. The rapid growth of the CGT market is pushing the packaging industry to innovate, to design systems that offer longer hold times, greater resilience, real-time tracking, and easier handling—all while meeting strict regulatory expectations for traceability and chain of custody.
In addition to packaging requirements, it’s all about communication and being able to quickly respond to issues and ensure delivery occurs on time.
Testing & Qualification
ISTA (International Safe Transit Association) distribution testing is essential to ensure a temperature-controlled packaging system can withstand the physical rigors of a distribution environment. Cold chain products, like vaccines and biologics, require packaging systems that can withstand transit stresses including vibration, shock, and temperature swings, while maintaining required temperatures. ISTA protocols, such as 7D and 7E, simulate real-world shipping conditions to verify packaging performance and product protection.
By testing and qualifying packaging against these standards, companies can ensure products arrive intact and within temperature specifications when shipped within complex shipping lanes. ISTA testing not only supports patient safety and regulatory compliance but also builds greater confidence in the resilience of cold chain logistics.
Interesting new ideas from conference discussions:
- Merck spoke about and emphasized the importance of humidity in compression testing
- Modality Solution presented the concept of developing a global test, eliminating the need for a custom approach for each product and supply chain. This was in relation to biologic drug product and how the combination of elements (pressure, temperature, vibration, etc.) are important to understand and produce different results than when tested each individually
- Eli Lilly talked about the effects of shock and vibration on secondary packaging and the need to reinforce packaging to reduce damage
Cold Chain Education
William Pelletier from the University of Florida, and Jean-Pierre Emond, former professor, University of Florida, led the discussion, “How do we get more people involved earlier and aware of the opportunity in Cold Chain?”.
Clearly as the conference sessions presented, the current and future demand for temperature-sensitive supply chains, the need for skilled professionals in cold chain packaging has never been greater. The session focused on the critical role of education, training, and talent recruitment in driving innovation and ensuring the efficacy of cold chain systems across industries such as pharmaceuticals, food, and biotechnology.
They emphasized the integration of industry-specific knowledge, technology, and sustainability practices, and the value of experiential learning and real-world case studies for the success of educational programs and their impact on industry readiness.
They ended the session by explaining we all must promote cold chain careers, enhance college programs, and build partnerships between the private sector, professional organizations, and universities to foster a pipeline of highly competent professionals.
ISTA is Awesome
The future of cold chain isn’t just evolving — it’s accelerating. As the pharmaceutical landscape shifts toward more sensitive therapies, direct-to-patient models, and global distribution complexity, the demands on packaging engineers and supply chain professionals are higher than ever.
Innovation, collaboration, and education aren’t just nice to have; they are the foundation of what’s next. The conversations at ISTA made it clear: those who invest in smarter design, deeper industry standards, and the next generation of talent will be the ones who lead the cold chain into its critical next era.
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[1]ASHP Cold Chain Management Resource Guide – new drug approvals requiring cold storage ashp.org.
[2] Specialty drug spending and pipeline trends carelonrx.comcarelonrx.com.