Life Sciences Manufacturing Innovation – The Value Framework as a Guide on the Road to Smart Factory of the Future

Several significant trends and innovations are shaping the future of life sciences manufacturing. First, there is an increased focus on continuous manufacturing processes with improved quality, throughput, and yield. This strategy makes predictions easier and enables manufacturers to anticipate deviations from the production target and automate corrective actions. There is also continued demand for aseptic processing, a manufacturing method that can produce a product that is absent of bacteria without subjecting the product to terminal sterilization processes.

Many products degrade and become ineffective when subjected to the harsh conditions of terminal sterilization. Aseptic process manufacturing allows these products to be produced in a sterile environment, allowing them to maintain their effectiveness while injecting safely into patients. The demand for sterile manufacturing capacity drives advanced aseptic single-use technologies.

What are the trends in pharma manufacturing?

In this PTC Talks, Lone Harboe, Nordic Consulting Lead for Life Sciences at Cognizant, discussed Life Sciences Manufacturing Innovation – the Value Framework as a guide on the road to the Smart Factory of the Future. Data and analytics are at the heart of this, with the pharma industry witnessing rapid investments in IOT solutions, advanced manufacturing and information solutions, and rapid adoption of IIoT enabled solutions. The use of data aggregation and AI solutions help pharma companies to grow their capacity and support the expanded demand for drug manufacturing. In addition, the rapid adoption of IIoT-enabled solutions such as automated operations, simulations, and self-service data analytics help pharma organizations meet their operational and quality goals. This is supported by an accelerated investment in integrated, full-stack solutions that support manufacturing 4.0.

Another big trend in the life sciences industry is moving from standardized large-scale manufacturing for large populations to specialized, small volumes for small populations with rare diseases. These demand dynamics require flexibility and scalability from short cycles with portable, continuous, miniature, and modular (PCMM) solutions that deliver plug-and-play ability on the factory floor. This may seem a radical transformation, but according to an article in Pharma Outsourcing, one in every ten people is now affected by a growing array of more than 7000 classified rare diseases, raising pressure on pharma to address a broader range of illnesses. With cell therapies, you can cultivate cell therapy-based modalities that apply to a large population and to a single patient. With this, we have placed a single patient in the supply chain, which is an extreme scenario. That requires pharma companies to pivot, find more agile and flexible ways, and reconfigure the existing capacity to meet those needs. But we are looking at these new, very targeted therapies with multi-tasking production scenarios that include complicated batching, meticulous tracking, and frequent changeover requirements, which nobody likes in manufacturing.

For pharma manufacturers, it is an ongoing struggle between balancing the requirements of today, where they need to deliver products to patients amidst increasing demands for compliance and quality, and extracting more from existing capacity while simultaneously expanding rapidly. Alongside that, they need to start thinking longer term about the foundation and enabling capabilities required to plan the roadmap to a future manufacturing strategy.

What comprises the factory of the future?

The factory of the future is the result of core foundational technologies that are empowered by new enabling technologies that drive real business value. Different process layers across many business areas are supported by foundational technologies and disciplines such as manufacturing execution, batch release, warehouse, automation, data historian, quality assurance, and IoT. These are the existing technology stack that might need to be augmented or reconfigured. The enabling technologies will enhance these process layers providing interoperability, backbone messaging, streamlined data, fully integrated platforms, and legacy systems through IoT. These are the prerequisite for the digital building blocks to function. For instance, data lakes and data architecture; if you do not have good data architecture with data standardization, it will not be possible to make sense of the data to serve it up in real time for the person who needs it at that moment. Then finally, the value-driven building blocks are the consuming applications that leverage the foundational and enabling technologies to define and drive business value.

There is often confusion about the terminology here. Many call it the factory of the future, while others prefer a smart factory. But the two terms are interchangeable because the factory of the future is smart; it is connected, data-enabled, and able to predict, prescript, and adapt. The smart factory vision drives business outcomes. And this is where the smart factory can differ from the factory of the future. A factory could have the latest technology, but if you are not making sense and getting business value from the data you have collected and saved in your data lake, then it is not smart. If you are not creating a data architecture with data standards and applying the right analytics, getting business value out of that data lake will never be possible.

Why is it crucial to identify business needs?

It is important to articulate these business drivers tailored to a particular manufacturer's needs. A manufacturer looking to optimize their bulk manufacturing and remain in that space has different problem statements than those shifting to small, nimble, portable manufacturing facilities. When you talk about faster, better, and leaner as top-line drivers, you are talking about launch acceleration, sustainability, and driving productivity. When you know your business driver, that becomes the 'North Star' in deciding every single use case you are looking at. If the use case does not deliver on those business drivers, they have no place in the portfolio.

When you look closer at the value framework, it is a guide for decisions on foundation and enabling technologies and the why and when of specific use cases on the roadmap to a digital plant. Ultimately when we talk about driving business outcomes, we are talking about driving competitive advantage. This is where a sense of urgency is needed within pharma manufacturers. They might have good acute responses for a problem on the production line, but it is often lacking when it comes to longer-term urgency. Everything takes time, and pharma manufacturers will be at a competitive disadvantage if it is not started soon.