Advancing Packaging Technologies for Climate-Adaptive Supply Chains

February 20, 2024 - The global climate crisis poses significant challenges to the biopharmaceutical industry, particularly regarding packaging and temperature control. The increasing unpredictability of weather patterns can lead to fluctuations in temperature during transportation and storage, potentially compromising the integrity and efficacy of pharmaceutical products. 

Improper temperature storage or delays in shipment can have severe consequences. Pharmaceuticals reaching their destinations after expiration can become ineffective or even harmful to patients who rely on them for critical medical needs. This jeopardizes patient safety and results in substantial financial losses for the industry, estimated to be around $35 billion annually. 

Importance of Packaging in Biopharma Supply Chains 

Packaging plays a vital role in maintaining the efficacy of pharmaceutical products, protecting them from external factors such as temperature variations, and ensuring their safe delivery to patients. However, with the increasing challenges posed by climate change, addressing packaging issues in the pharma supply chain becomes even more complex. 

In an interview with PharmaNewsIntelligence, Alex Guillen, a Global Subject Matter Expert (SME) for Life Science and Pharmaceuticals at Tive, emphasizes the significance of packaging in the biopharma supply chain. Temperature-sensitive products, such as medications, can lose efficacy with each exposure to temperature fluctuations. Guillen uses an analogy to explain how these products gradually lose their power and energy, leading to a decline in effectiveness.  

"Basically, when products are shipped today, they undergo a significant evolution. The crucial point to understand is that temperature-sensitive products, especially, lose their efficacy over time with each exposure to specific levels and changes in temperature," explained Guillen. "Think of it like a game where one starts with 100% efficacy and power, and each time it is 'punched,' the figure decreases to 95%, 90%, 85%, and so on." 

Packaging is a protective shield, safeguarding biologics and pharmaceuticals from the beginning of their journey until they reach the end-user. It ensures that medicines do not lose efficacy due to excursions beyond the specified temperature range.  

"If there's an excursion, the medicine goes beyond the temperature range, and with each exposure, it gradually loses effectiveness,” he said. “There's no way to revert back. Eventually, the medicine becomes ineffective, leading to waste or significant costs due to the need for replacement. That's why packaging is crucial — it protects the medicine throughout its entire journey." 

Packaging Challenges 

During the interview, Guillen highlighted a specific example from the COVID-19 pandemic where the Pfizer–BioNTech vaccine had to be transported at an ultra-cold temperature of –70 °C. The extremely cold temperature requirement for the vaccine posed a substantial challenge, as most vaccines and biologics are transported within the temperature range of 2–8°C. 

Maintaining such low temperatures adds complexity to the packaging requirements and logistics of the biopharma supply chain.  

"When dealing with temperatures as low as –70°C, considerations such as dry ice, liquid nitrogen, or liquid CO2 come into play. There are various alternatives, but the main point is that it poses a significant challenge,” highlighted Guillen. 

To overcome these challenges, the industry must work toward developing specialized packaging solutions that can safely and effectively transport temperature-sensitive products in such unique circumstances. 

Inadequate Packaging and Its Consequences 

Insufficient packaging in the biopharmaceutical supply chain can have severe repercussions. Guillen described a significant challenge he had faced, which involved using single-use packaging for biologics and pharmaceutical products. 

"These packages were single-use, leading to the disposal of large amounts of expanded polystyrene (EPS) material, resulting in environmental waste without any viable recycling options,” he continued. “Not only did this contribute to the accumulation of waste in landfills, but it also had a negative impact on the environment." 

Disposing of single-use packaging materials resulted in environmental waste and raised concerns about sustainability. The reliance on outdated insulation materials and cooling agents further compounded the challenges. 

"There were also challenges associated with using ice  as it melts and creates humidity. This could potentially affect the stability and efficacy of the pharmaceutical products being transported, leading to potential risks and compromises in their quality," Guillen stressed. 

These challenges underscore the importance of implementing sustainable and efficient packaging solutions throughout the biopharmaceutical supply chain. By adopting eco-friendly and multi-use materials and sustainable insulation techniques, the industry can minimize waste, reduce environmental impact, and ensure the safe and effective transport of temperature-sensitive products. 

Climate Change's Influence on Packaging and Logistics 

Climate change presents new challenges for maintaining pharmaceutical products' integrity during transportation and storage. Guillen emphasizes that packaging needs to be validated based on the temperature profiles experienced during transit. However, climate change has made weather patterns increasingly unpredictable.  

"Climate change has made it harder to predict temperature ranges and variations, and this unpredictability makes it difficult to design packaging that can withstand a wider range of temperatures," he added. 

The fluctuations in temperature resulting from climate change require the development of packaging solutions that can adapt to mitigate the risks associated with temperature excursions. Guillen emphasized the importance of creating packaging with thermal properties and designing packages that can effectively adjust to different temperature ranges and conditions.  

To achieve this, Guillen recommends companies prioritize research and development efforts to produce packaging capable of withstanding a wider spectrum of temperature variations. By making this investment, companies can safeguard the integrity of their products throughout the entire supply chain, resulting in cost savings. 

Addressing Packaging Challenges 

The industry is addressing the climate change-related challenges by introducing innovative and sustainable packaging solutions. Guillen highlighted the transition from single-use to multi-use packaging as a means to reduce waste and promote environmental friendliness.  

Unlike single-use packaging, multi-use packaging is designed to be reused multiple times, significantly reducing environmental impact.  

The pharmaceutical industry is estimated to produce more than 300 million tons of plastic waste annually, half of which is single-use. Considering that 85% of the waste generated by healthcare-related entities — including packaging for pharmaceuticals and medical equipment — is non-hazardous, there is potential to replace it with more environmentally friendly or reusable alternatives. 

"The concept of multi-use packaging involves creating boxes or containers that can be utilized multiple times, effectively minimizing waste," Guillen stated. 

This shift not only addresses the problem of waste disposal but also brings long-term cost savings for companies.  

In addition to multi-use packaging, active packaging systems, and phase change materials are being developed to maintain temperature control during transportation and storage.  

"Active packaging systems incorporate sensors or devices that can record information, such as temperature, and transmit it to a database or cloud for analysis by the sender and receiver,” he pointed out. 

These systems allow real-time monitoring of temperature conditions, ensuring any deviations are detected and addressed promptly. 

Climate-adaptive packaging technologies are being researched and developed to protect biopharmaceutical products from temperature fluctuations and ensure safe delivery despite changing climate conditions. These innovations include temperature monitoring devices, insulation materials, and active cooling systems. Implementing these technologies brings benefits like reduced product spoilage, enhanced supply chain resilience, and minimized financial losses for manufacturers and distributors. Most importantly, climate-adaptive packaging safeguards patient health by preserving medication potency throughout the supply chain. 

Packaging is critical in the biopharmaceutical supply chain, ensuring the integrity and efficacy of pharmaceutical products and biologics. However, the climate crisis adds an extra layer of complexity to these challenges, demanding innovative packaging solutions that can adapt to unpredictable weather patterns.  

The industry can address packaging issues by embracing reusable packaging, developing active systems, and utilizing renewable energy sources while minimizing waste and environmental impact. As Guillen's insights demonstrate, collaboration is essential to navigate the evolving landscape and ensure the safe delivery of medications to patients worldwide.