Elinor Robertson, global quality manager at Biocair shares the importance of managing risk across the cold chain.
Biocair
Lyophilisation, or freeze-drying, has become a critical manufacturing process for many biologics, vaccines and advanced therapies. By removing moisture and improving stability, it helps extend shelf life and supports the global distribution of sensitive products. However, while lyophilisation reduces certain risks, it does not eliminate them.
Today’s pharmaceutical supply chains are more complex than ever. Products may travel across multiple countries, pass through numerous regulatory environments and require tightly controlled shipping conditions before reaching a manufacturing site, clinical trial location or patient. As a result, protecting product integrity does not end when manufacturing is complete – it requires careful management throughout the entire cold chain.
For pharmaceutical manufacturers, maintaining product quality, regulatory compliance and patient safety depend on a proactive approach that reduces risk at every stage of the journey.
Protecting product integrity beyond manufacturing
Although lyophilised products are generally more stable than their liquid counterparts, many still require protection from humidity and specialist handling throughout transport and distribution.
The stakes are high. A temperature excursion, customs delay or handling error can compromise an entire shipment, leading to product loss, operational delays, increased costs and potential impacts on patient care.
This challenge becomes even greater for products with strict temperature requirements. Manufacturers must consider:
- Temperature excursions during transit
- Delays caused by customs or transportation disruptions
- Chain-of-custody gaps
- Human error during handling
- Regulatory compliance requirements across multiple jurisdictions
As therapies become more specialised and valuable, logistics plays an increasingly important role in safeguarding both product integrity and scientific progress.
Managing ultra-low temperature supply chains
Many modern therapies, including biologics and advanced therapeutic products, require transport at ultra-low temperatures (ULT). These supply chains present a unique set of challenges, as recovery options following a temperature deviation can be extremely limited.
Successful ULT logistics requires more than specialist packaging. It depends on a carefully coordinated strategy that includes:
- Validated temperature-controlled packaging solutions
- Continuous monitoring and data collection
- Robust chain-of-custody procedures
- Rapid-response capabilities when unexpected events occur
Because these products often represent years of research and significant investment, effective risk management relies on anticipating potential issues before a shipment moves and ensuring safeguards are in place throughout the journey.
Proactive planning
The most effective cold chain strategies begin long before products enter transit.
Successful manufacturers take a proactive approach, identifying potential vulnerabilities across the entire shipment journey and implementing measures to reduce exposure to risk. Many common disruptions, including temperature deviations, customs delays, route interruptions and visibility gaps, can often be anticipated through detailed planning and risk assessment.
Key considerations include:
- Selecting validated packaging appropriate to the product and transit profile
- Planning routes based on destination, transit times and environmental conditions
- Assessing seasonal weather and geopolitical risks
- Reviewing customs and documentation requirements
- Building contingency options into the shipment plan
Rather than reacting to problems after they occur, proactive planning helps manufacturers maintain control and minimise disruption throughout the supply chain.
Preparing for the unexpected
Even the most carefully planned shipment can face unforeseen challenges. Flight cancellations, severe weather events, airport congestion, customs inspections and infrastructure disruptions all have the potential to impact temperature-sensitive products. For high-value pharmaceutical shipments, the ability to respond quickly can make the difference between maintaining product integrity and losing a critical shipment.
Effective contingency planning should include:
- Alternative transportation routes
- Backup packaging solutions
- Escalation and communication procedures
- Real-time decision-making capabilities
- Access to experienced logistics specialists
One of the greatest risks facing international shipments is a lack of proactive risk planning. Organisations that identify potential disruptions in advance are better positioned to protect products and maintain continuity when circumstances change.
Visibility, accountability and specialist expertise
Maintaining control across global supply chains requires complete visibility, clear accountability and access to specialist expertise.
Real-time shipment monitoring and end-to-end tracking provide valuable insights into a product’s location, condition and progress. However, visibility alone is not enough. Manufacturers also need confidence that issues will be identified, escalated and resolved by experienced professionals who understand the unique demands of life sciences logistics.
Navigating an evolving regulatory landscape
Alongside operational complexity, manufacturers must contend with an increasingly demanding regulatory environment.
GDP requirements, import and export regulations, country-specific controls and evolving quality expectations continue to shape the movement of pharmaceutical products worldwide. Compliance depends on validated processes, documented controls, complete shipment visibility, and clear audit trails demonstrating that products have remained protected throughout their journey.
With increasingly complex international distribution, organisations need logistics partners with the expertise to navigate changing regulations while maintaining speed, compliance and product integrity.
Building a more resilient cold chain for the future
As pharmaceutical products become more specialised, cold chain resilience will continue to be a strategic priority.
The most successful organisations will be those that combine data, expertise and proactive risk management to anticipate challenges before they impact operations.
By strengthening visibility, improving contingency planning, embracing operational flexibility and working with experienced logistics specialists, manufacturers can build supply chains capable of supporting the next generation of therapies.
Conclusion
The journey after lyophilisation is just as important as the manufacturing process itself. While freeze-drying can improve stability and extend product shelf life, protecting high-value therapies requires an end-to-end approach that spans handling, transportation and global distribution.
Through proactive planning, robust contingency measures, end-to-end visibility and clear accountability, manufacturers can minimise risk and maintain product integrity throughout the cold chain.
Logistics is about more than moving products – it is about protecting scientific progress and ensuring life-changing therapies reach the patients who depend on them.