The US pharmaceutical cold chain is a vital component of the healthcare industry, ensuring that temperature-sensitive products, including vaccines, biologics, and gene therapies, maintain their efficacy and safety during transportation and storage. However, managing this cold chain is both complex and costly, with ongoing challenges that require innovative solutions. The HDA Research Foundation’s 2024 Report: The Future of U.S. Pharmaceutical Cold Chain Report recently provided a comprehensive overview of the current state, successes, challenges and future U.S. pharmaceutical cold chain considerations.

Cold chain products are significantly more expensive than traditional small-molecule drugs. On average, a daily dose of a cold chain drug is estimated to be 22 times more costly, with some cell and gene therapies priced at or above $1 million per treatment. This high cost amplifies the impact of any temperature excursions, potentially leading to expensive drug losses. This makes maintaining the cold chain’s integrity absolutely critical to avoid financial losses and ensure patient safety.

The pharmaceutical industry is witnessing continuous innovation in cold chain packaging across all temperature ranges. Notable advancements include containers that can maintain 2 to 8°C for up to 300 hours, lighter containers for ultra-low temperatures, and liquid nitrogen dewars that can be used in any physical orientation. Additionally, there is a growing adoption of prequalified packaging, which eliminates the need for validation testing before use, and reusable packaging to reduce the environmental footprint.

Despite these advancements, the US pharmaceutical cold chain is rated relatively effective, with an overall effectiveness score of 7.9 out of 10 according to cold chain experts. However, they also identified areas for improvement, particularly in the “last mile” and “last 10 feet” of delivery, where inadequate handling and lack of cold environment maintenance pose significant risks to product integrity.

Current Challenges in Cold Chain Operations

The rapid growth of cold chain products is outpacing current processes, necessitating a refresh in operations. Experts highlight several ineffective practices, including:

  • Lack of Packaging Standards: The absence of industry-wide packaging standards leads to a proliferation of different packaging types, requiring distributors to repackage products, which increases costs and complexity.
  • Inconsistent Cooling Methods: The use of passive cooling instead of active cooling requires separate packaging for each shipment, further complicating logistics.
  • Sustainability Concerns: There is a lack of sustainable and reusable packaging solutions, contributing to environmental waste.
  • Inconsistent Monitoring: Real-time monitoring is not consistently applied, leading to potential missed delivery deadlines and failures to meet temperature control requirements.
  • Last Mile Deliveries: Delivering to remote locations that require temperature-sensitive materials to remain at their desired transportation temperatures for extended periods of time compared to standard local deliveries remains a challenge. Inconsistent supply of refrigerants or cooling methods results  in temperature changes either affecting the integrity of the materials in transportation or delays to replenish the refrigerant materials. 
  • Inventory Management: Accidental mismanagement of inventory can lead to significant losses and operational inefficiencies.

Insights from Cold Chain Stakeholders

Manufacturers expressed confidence in their ability to deliver cold chain products effectively but identified packaging standardization and visibility into the product’s temperature throughout the process as critical areas for improvement.

Distributors emphasized the need for standardized packaging to streamline cold chain operations, enhance sustainability, and reduce waste. They noted that varying pack-out sizes among manufacturers increase the burden on distributors to repackage products.

Shippers face challenges with inconsistent packaging standards and cooling methods, especially with air shipping, which complicates the shipping process and threatens the integrity of cold chain products, not to mention the exorbitant costs associated with air shipping.

Pharmacies did not provide specific feedback, but the overall sentiment across the industry is that more consistency and communication are needed to improve cold chain operations.

Priorities for Improving Cold Chain Operations

  1. Consistency: There is a lack of industry-wide dialogue and communication to drive standardization in cold chain practices. Experts call for the establishment of industry guidelines to ensure consistency across the board.
  2. Shipping Lane Exceptions: Common issues include packages arriving at closed businesses or being left unattended, inadequate planning for inclement weather, and failures in cooling systems.
  3. Cost vs. Quality: While quality remains the top priority, experts note that using alternative refrigerants like PCMs could reduce costs and support sustainability efforts.
  4. Sustainability: Enhancing sustainability is a long-term goal. The pharmaceutical sector contributes significantly to the healthcare industry’s carbon footprint, with single-use packaging being a major environmental concern. Experts suggest reducing air freight dependence, increasing the use of reusable packaging, and extending temperature control capabilities to allow for more road transportation.

This comprehensive overview of the US pharmaceutical cold chain underscores critical areas requiring immediate attention. To prepare for the future and address the challenges highlighted, the following steps focus areas were summarized in the report findings:

 

  • Invest in Infrastructure: Enhance infrastructure to manage the anticipated growth in cold chain products, ensuring capacity and efficiency.
  • Annual Cold Chain Forum: Establish an annual forum focused on cold chain distribution to foster industry collaboration and drive innovation.
  • Strategic Distribution Planning: Integrate enhanced distribution considerations during drug development and planning phases to ensure a seamless cold chain process.
  • Excursions Management Playbook: Develop a robust playbook for managing exceptions and excursions, minimizing risks associated with temperature deviations.
  • Cold Chain Workforce Certification: Implement certification programs to ensure a highly skilled and knowledgeable cold chain workforce.
  • Sustainable Packaging: Prioritize the use of sustainable packaging solutions to reduce the environmental impact of cold chain operations.