New temperature monitoring approach improves efficiency for Lundbeck

The Partner

Lundbeck is a global pharmaceutical company engaged in the research, development, manufacturing, marketing and sale of pharmaceuticals that target brain diseases. For more than 50 years, they have been at the forefront of research in neuroscience with key areas of focus being alcohol dependence, Alzheimer’s disease, bipolar disorder, depression/anxiety, epilepsy, Huntington’s disease, Parkinson’s disease, schizophrenia, stroke, and symptomatic neurogenic orthostatic hypotension (NOH).

Headquartered in Copenhagen, Denmark, Lundbeck employs 5600 in more than 50 countries, and their products are registered in more than 100 countries. They have production facilities in Denmark, France and Italy.

The Project/Challenges

Lundbeck’s supply chains are extensive and global. For clinical trials, they use ten clinical depots and a vast number of clinical sites across the globe, depending on the hospital’s patient population and need for the therapeutic. For each study, there is a new product with new temperature requirements, new lanes and sites. Consequently, Lundbeck demands extreme flexibility and reliability in a temperature monitoring solution.

Lundbeck’s clinical supply chain has been using ELPRO’s liberoMANAGER since 2013 and have established robust processes with the system.

However, Lundbeck’s commercial supply chain had been using a different monitoring solution, without any automation in place. Unfortunately, the previous solution included some significant limitations and challenges:


Too slow and inflexible

• If the temperature was exceeded, the data logger had to be sent to Ludbeck’s quality assurance department by mail.

• All notifications for alarms and other issues were manual, creating significant time delays.

• With multiple consignments, the strict temperature profile had to be applied to the entire consignment which, in the event of a temperature excursion, resulted in a quarantine of the entire consignment.
  
  

Lack of transparency to optimize the process and costs.

• Missing baseline data to create statistics for continuous improvements.

• No collected data to evaluate services of transport partners and sites.

• Not sufficient data to evaluate packaging performance and optimize packaging costs.
  
  

No synchronization between departments.

• Qualification of different data loggers

• Implementation and maintenance of different SOP’s

• Missing economies of scale at the supplier.

The ELPRO Solution

It became clear to Lundbeck stakeholders that using the LIBERO Cloud solution, currently is use for the clinical supply chain, would result in substantial benefits if used for the commercial supply chain.

The robust flexibility of the LIBERO Cloud solution allows for specific workflows for each department. Within the software, the different processes work independently of one another and still achieve maximum synergy effects, including:

• Use of the already qualified data logger family LIBERO Cx

• Upgrade from the existing liberoMANAGER account to the latest software version that allows completely different processes to work independently of each other

• Automate commercial supply chain processes to reduce human error and costs

• Identify cost savings and continuous process improvements across logistics service providers, packaging and lanes
  
  

Design Workshop

In a design workshop with all key departments, the individual process steps and possible solutions were discussed with the ELPRO key account manager responsible for Lundbeck. This collaboration between Lundbeck and ELPRO allowed for a thorough definition of system set up and benefits. Having all stakeholders involved ensured an acceptable and robust long-term solution that met each department’s needs, and the overall business cost-saving and operational objectives.

As a result, ELPRO’s cloud SaaS database, LIBERO CLOUD, was implemented as a solution. The LiberoMANAGER software was customized to fit existing processes and support immediate decision making so there are no supply chain delays. Different users have different access rights to the system. Thus, when there is an alarm, a notification is sent to the correct person depending on who needs to be notified. liberoMANAGER acts as a project manager by sending automated notifications to the correct, relevant contacts.

According to Mikkel Pind, Lundbeck specialist GDP, the use of liberoMANAGER had an added benefit: transparency. “liberoMANAGER has enabled transparency across our organization,” said Pind. “With critical temperature data in the cloud, our supply chain teams across global sites can access the information for transport validations and make informed decisions for routes they are booking. We can foresee problems better and make informed decisions to protect our products.”

Summary: Synchronization does not mean giving up customization

After implementing the adaptable LIBERO Cloud solution across the entire organization, Lundbeck realized immediate and long-term cost-saving benefits including:

• Streamlined qualification of hardware and software

• Reduced implementation efforts (less resources, people to have in one system)

• Less maintenance efforts (e.g. requalification after systems updates)

• Performance of packaging

• Performance of qualified transport lanes

• Performance of LIBERO data loggers

• Significant continuous improvement costs savings by measuring KPIs across departments, including:

• Performance of service provider (logistics or warehousing)

As a result, Lundbeck can continue to focus on the core business of R&D because they know the vital temperature date and associated information are safe and taken care of in the LIBERO Cloud cold chain monitoring system.

Moreover, as the date is accessible at all times from any location in the world, clinical trial delays at hundreds of sites have been reduced.

Lundbeck’s commercial supply chain can finally create a complete audit trail by requiring upload of data to be able to release the product, no more chasing missing reports.

ELPRO is pleased to be a strategic partner with Lundbeck to provide a platform that allows their clinical trial supply team to create an efficient and GDP compliant supply chain with the ELPRO LIBERO Cloud solution they have implemented.

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