Patient safety and environmental sustainability are driving cold chain innovation in the life sciences industry. Advanced technologies are essential for maintaining product integrity and ensuring safe, effective treatments worldwide.
The biopharma industry faces substantial challenges in managing temperature-controlled logistics, leading to an estimated $35 billion in annual losses due to cold chain failures. According to the World Health Organization (WHO), 50% of vaccines are rendered ineffective upon arrival due to uncontrolled temperature fluctuations. This not only poses risks to patient health, but also results in significant environmental and resource wastage. Every damaged vaccine represents a loss of raw materials, energy, and resources invested in production, transportation, and storage — ultimately contributing to environmental strain through increased waste.
Cold chain management is crucial for preserving the efficacy of temperature-sensitive products like vaccines and biologics. In the U.S., FDA regulations, including the CGMP and USP <1079> Good Storage and Distribution Practices for Drug Products, mandate temperature control to help ensure drug stability throughout the supply chain. Similarly, the EU Good Distribution Practice guidelines require strict temperature monitoring to maintain pharmaceutical quality, setting high standards for handling temperature-sensitive products.
To address these challenges, companies in the life sciences industry are leveraging advanced technologies with SAP Business Technology Platform (SAP BTP) to proactively manage temperature fluctuations.
SAP BTP enables seamless integration and data sharing across systems, providing critical insights for rapid, data-driven decisions that help maintain temperature stability. This strengthens supply chain resilience, minimizes product loss, and reduces environmental impact, helping ensure the safe and effective delivery of temperature-sensitive products.
Fusion’s Cold Chain Management Solution
In this context, Fusion Consulting has developed Cold Chain Management Solution (CCMS), a standard solution built on SAP BTP in close collaboration with the SAP product team for Life Sciences. The solution supports the integrity of temperature-sensitive products, including medicines, vaccines, and other perishables across the end-to-end supply chain. Any failure can result in temperature excursions and deviations, which threaten product efficacy and pose risks to patient safety while also leading to financial loss.
CCMS supports the management of products under controlled storage, preventing temperature excursions and deviations throughout the supply chain. Typically, manufacturing and supply processes track time out of refrigeration (TOR) and time In refrigeration (TIR), both of which accumulate the time a product spends within different temperature zones — cold, ambient, or frozen, for example — on the journey from the production line to the patient at the end of the supply chain.
Before Fusion CCMS, tracking TOR and TIR relied on a combination of custom-built in-house legacy systems, as well as error-prone manual paper-based processes. This led to complicated, time-consuming workloads, high error rates, re-work, and bureaucracy — all of which ultimately risks patient safety, product efficacy, and regulatory compliance.
CCMS digitalizes TOR and TIR tracking, offering full visibility of temperature conditions across the supply chain to proactively prevent anomalies. With automated workflows and smart alerts, it minimizes spoilage and patient risk, integrating with SAP systems to enhance efficiency and safety through automated data from RFID and IoT devices.
“The Fusion Cold Chain Management Solution exemplifies the power of collaboration and innovation on SAP BTP,” said Andreas Krummlauf, vice president of Life Sciences and Healthcare Product Management at SAP. “By addressing critical challenges in temperature-sensitive product management, it enhances patient safety, regulatory compliance, and reduces environmental impact. This solution perfectly extends our SAP for Life Sciences solution portfolio, aligning with our strategy to offer comprehensive capabilities to our customers. We’re proud to support partners like Fusion in developing cutting-edge solutions that drive meaningful change in life sciences delivery.”
“The collaboration with SAP is a prime example of how innovative strength and expertise can lead to literally life-saving solutions that transform the industry, such as the CCMS,” said Fares Zaier, chief revenue officer of Fusion Consulting.
Critical Link with Quality Management and Batch Release
The described TOR information is one of the crucial attributes that need to be checked by the Quality department. This is relevant throughout the whole supply chain process, whenever a batch decision needs to be taken. Throughout the entire value chain, sharing this information is of utmost importance.
Having the SAP Batch Release Hub for Life Sciences solution and Fusion CCMS both built on the SAP BTP Platform enables seamless integration into the process flow. This in turn enables seamless integration of systems, helping ensure data consistency and optimizing processes.
By combining these powerful solutions, companies in the life sciences industry lay the foundation for future innovations. Ultimately, the close cooperation between Fusion Consulting and SAP has enabled the development of solutions that not only meet current requirements, but also those of the future.
Looking to the future, Fusion plans to set up its industry consortium working with top life sciences customers to continuously taking their feedback and requirement into the product design and development.
Aladdin Mandishah is director of Product Marketing for Life Sciences at SAP
Marco De Lorenzo is vice president of Product Marketing for Life Sciences at SAP.