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How Industry 4.0 and Supply Chain Solutions Are Transforming the Biopharmaceutical Manufacturing Industry


An incredible amount of data is generated in the biopharmaceutical industry – from manufacturing, to storing, to transporting pharmaceutical drugs, not to mention regulatory data, and until now, it’s been extremely challenging to collect this data at all points along the supply chain and extract insight from it.

The current Covid-19 Pandemic is exposing information gaps within supply chains and the high cost of disjointed supply chain data for organizations. Hampered by an incomplete picture of their supply chain, organizations are unable to respond quickly to the rapidly changing conditions. Fortunately, with the advent of new data-driven technologies, it’s now possible to capture data from all points along the supply chain, transform it, and act on it.

What’s the best path forward in terms of embracing digital technologies in the pharmaceutical supply chain? In this blog, we’ve compiled interviews with innovators in the pharma industry and companies that are leading the way in digitizing how they do business.

Digitally Transforming the Industry

The Executive Platforms bluEPrint Podcast had a chance to catch up with Cloudleaf VP of Sales Randy Erwin last fall at the Biomanufacturing World Summit, where Erwin gave insights into the digital transformation of the biopharmaceutical industry. He said that one challenge of transitioning to a digital supply chain management system is breaking down data silos.

“A lot of technology that is used to help people in the pharmaceutical industry is functionally focused, so informational silos start to naturally develop,” Erwin said. “To break down these silos and provide full context visibility for action, you need to see all streams of data in a single location such as streams feeding a lake. This can serve as a common source of data aggregation and a common source of information, which stakeholders can take action on.”

Leaders in today’s biopharmaceutical industry need a clear vision and effective teams to carry out that vision. That’s only possible, said Erwin, if those leaders have all of the data relating to their supply chain at their fingertips.

“Cloudleaf provides a visibility platform that can ingest all of the signals in the physical world and formulate a real-time picture of the status of a particular product or factory,” he said, “so that executives can stay informed and make critical, real-time decisions.”

Listen to Randy Erwin’s interview

Digital Transformation and the Smart Factory

From the supply chain to the manufacturer to the production floor, going digital can save companies millions of dollars and give direct access to all kinds of data that affects quality and quantity. Manufacturers that have implemented IIoT technology into their processes have become known as “Smart Factories.”

Laks Pernenkil, Principal at Life Sciences Operations with Deloitte Consulting LLP, told Executive Platforms he’s seen many companies make progress in transitioning their factories into Smart Factories.

“A lot of our clients have been focused on trying to figure out how to bring next-gen technologies to their production floor,” he said. “Specifically, they are looking to add digital and smart factory capabilities in manufacturing process development and quality departments. One of the things that we’ve been having conversations with is how to make that a reality in biopharma environments.”

According to Pernenkil, everything in the biopharma environment should be grounded in value. His organization has identified “four drivers of performance that all our biopharmaceutical clients are most focused on and are achieving through smart factory investments.”

  • Human performance: Reducing error rates in the production floor is a key enabler for biopharmaceuticals.
  • Process performance: Getting that extra yield, extra product, and extra gram apart from the current processes is critical for manufacturers to achieve value on their production floors.
  • Asset performance: Discovering more uptime from manufacturing assets so manufacturers can achieve better utilizations and better returns on investment.
  • Network performance across their entire network: Optimize and generate the performance that you need from your manufacturing network. Manufacturers need to focus on all these four levels “and look at a smart factory as an enabler and an arrow in their quiver to achieve those four performance levels.”

Pernenkil said governance of data is essential for biomanufacturers to fully take advantage of having Smart Factories.

“Each of the various parts of the operations organization, whether it’s tech services, process development, manufacturing or quality —they all need to have ownership and control of the data that they’re creating in operations.”

Architecting the 2025 Supply Chain

Notable supply chain experts Accenture Strategy made it clear in a recent publication that modern supply chain design and execution “barely meet today’s business imperatives.” Future supply chains will need to be flexible and open to fast implementation of new technologies. Such direction will be best managed by the position of Supply Chain Architect, who maintains supply chain effectiveness and searches for and integrates changes.

“Instead of looking internally and only optimizing their own assets,” Accenture Strategy stated, “companies will connect with an ecosystem of third parties to access shared assets, thus building more responsive supply chains. Individual customer orders will be fulfilled by whatever combination of partners best meets the service requirements at the time of execution.”

This is only possible by harnessing data-driven technologies to revamped supply chains built to give architects real-time data across the system. Accenture Strategy quoted Michael Danner of Danner & Danner Associates LLC as saying, “Automation through technology—if the data is connected correctly—will drive the entire supply chain end-to-end in terms of what’s being planned and executed. The planning piece will be automated, and the role of the planner will be more of reviewing the output to understand what the issues and options are to meet customer expectations as expected.”

Be a Part of the Future Right Now

The digital transformation of supply chains is certain, and the pandemic of 2020 has forced organizations to examine the health and strength of their supply chains. In order to take advantage of the benefits of a digital supply chain, you need to consider what your operating models need to look like to enable a “configure, operate, connect, manage” approach. Cloudleaf gives your supply chain the visibility needed to digitally see what’s happening at every step. This provides your company with a clear view into its processes, saving you money and establishing you as among the most innovative organizations in your industry.

Watch Randy Erwin’s interview