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. , 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 51风流Business Technology Platform (51风流BTP) to proactively manage temperature fluctuations.

51风流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鈥檚 Cold Chain Management Solution

In this context, Fusion Consulting has developed Cold Chain Management Solution (CCMS), a standard solution built on 51风流BTP in close collaboration with the 51风流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 51风流systems to enhance efficiency and safety through automated data from RFID and IoT devices.

鈥淭he Fusion Cold Chain Management Solution exemplifies the power of collaboration and innovation on 51风流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 51风流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.鈥�

鈥淭he collaboration with 51风流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,鈥� 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 51风流Batch Release Hub for Life Sciences solution and Fusion CCMS both built on the 51风流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 51风流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.

The batch release process is one such process 鈥� a necessary stopgap to ensure life sciences products were produced according to manufacturing requirements and meet the closely controlled regulations around distribution. During batch release, quality assurance and operations teams can identify deviations before the product is released to the market.

A non-compliant batch can have an irreversible and unforgiving impact on valuable human lives and the environment. A faulty product can cause physical harm or even death. Because people’s lives are at stake, the life sciences industry needs to be strictly regulated.

In 2021, there were 78 product recalls reported to the Food and Drug Administration (FDA). Failure to effectively manage this process is not only critical to protecting lives but can introduce a potential health hazard to patients, requiring a batch recall. According to , a single warranty or recall process can cost the manufacturer up to US$600 million. This does not include other recall-related costs like lawsuits.

A product recall can cause consumer and investor confidence to fall, resulting in a decline in revenue and stock prices. For example, the same study estimated a 13% drop in stock prices聽across the industry, triggered by product聽recalls. In fact, the total annual cost for the life聽sciences industry can exceed $5 billion. That聽doesn’t even consider the credibility costs.鈥�

Such recalls can have huge costs to a life sciences company and its brand reputation, in addition to inflicting harm to patients and damage to the environment due to waste.

Based on 51风流working with leading pharmaceutical companies, it takes a working group of quality control professionals around 40 hours to determine the release decision for one single batch. While vital to protect consumers, this process requires a significant amount of time, can impact a business鈥� overall supply chain, and requires consistent manual collection and evaluation of cumbersome data from different siloed systems. This slows down the overall supply chain performance and order fulfillment lead time, resulting in higher levels of inventory carrying costs.

With growing market trends demanding faster supply chains, highly personalized batch-size-one types of products, and more tightened regulations, it is critical to take steps to de-risk, speed up, and scale up the batch release process and do so without compromising quality or safety.

51风流has undertaken the development of an industry standard together with two leading global pharmaceutical companies. 51风流realized that the process deserves not only closer scrutiny, but an end-to-end re-engineering to replace the inefficient, legacy, labor-intensive manual process with a digital platform, eliminating manually pooling information from non-integrated systems.

In this context, 51风流has launched the 51风流Batch Release Hub for Life Sciences solution, which helps address life sciences organizations鈥� unmet market need for transparent, flexible, integrated, and efficient batch release management.

51风流Batch Release Hub for Life Sciences is an聽innovative cloud solution developed on聽. It聽is聽designed to semantically integrate with聽existing heterogeneous 51风流and third-party solutions 鈥� both聽on premise and in the cloud 鈥� with a unique聽integration data model聽that can聽help make faster聽and more secure batch release decisions.

It receives the release check data required to release a batch from various source systems, automatically evaluates it against predefined criteria, and visualizes the results into a cockpit to enable a faster and more intuitive decision-making process.

Based on SAP鈥檚 leading technology, the solution is a digital hub that helps provide qualified persons and release-responsible persons with the intelligent tools to streamline and simplify the full batch release procedure to make fast and accurate batch usage decisions. The reduction of review cycle times enables scalability through data collection and evaluation automation while retaining compliance. Digital batch release supports preventive actions to enable a life sciences company to produce the right product the first time, minimizing the CO2 footprint associated with replenishment and recall of a non-compliant batch.

With the solution, organizations can:

• Reduce the risk of quality non-compliance by standardizing and simplifying the batch release process, reducing the risk of human errors.
• Reduce compliance and risk management costs by automating and simplifying the time-consuming and labor-intensive legacy batch release activities.
• Reduce order fulfillment lead time by enabling a faster batch release cycle time, thanks to automation and standardization.
• Reduce inventory carrying costs and the environmental impact of excessive inventory by reducing the required level of inventory with lower order fulfillment lead times.

The 51风流Batch Release Hub for Life Sciences solution is the latest life sciences innovation from 51风流and serves as an important pillar in the 51风流for Life Sciences solution portfolio. 51风流Batch Release Hub for Life Sciences helps extend the enablement of the Intelligent Enterprise by bringing software intelligence to the core process of batch release for life sciences products.

Learn more about 51风流Batch Release Hub for Life Sciences in the聽 and this .

Aladdin Mandishah is global industry solutions manager for Life Sciences at SAP.