Leverage the Industry 4.0 Revolution to Meet Market Challenges
Bob Lenich
Global Life Sciences Director
Emerson Automation Solutions

Michalle Adkins
Life Sciences Consulting Director
Emerson Automation Solutions

The rise of the fourth industrial revolution, or Industry 4.0, which combines digital and physical advanced technologies, can potentially transform the life science industry. This article looks into the extent to which life science companies have positioned themselves in relation to this transformation and the opportunities the switch to industry 4.0 offer them.

The Life Sciences industry - with its major investments in research, reliance on complex chemistry, and sophisticated understanding of human biology - is generally regarded as a technologically advanced sector. However, when it comes to manufacturing technology; the same processes that have been used since the mid-20th century have remained. Until recently, this has been an acceptable strategy. But with increasing levels of complexity and increased competition in the market, Life Sciences manufacturing is going through a transformation.

Today, Life Sciences manufacturing facilities can take advantage of stateof- the-art digital automation systems and seize opportunities to improve operations. Increasing market competitive pressures demand efficient operations, manufacturing flexibility, and integrated supply-chain management. Going forward, Life Sciences manufacturing companies must invest in the new technologies that digitization and the Industry 4.0 revolution enable to stay current, competitive, and compliant.

Currently, many companies operate with disconnected and inefficient legacy systems that are challenged to respond to dynamic shifts in manufacturing supply and demand. Companies have increased expectations for real-time release and for more visibility to all the manufacturing activity, data collection, and analysis. Including the growing requirements from increasing regulatory scrutiny and cyber security means improved quality controls, better system management, and more access to data.

Digital automation solutions hold tremendous potential to help Life Sciences companies address each of these exacting regulatory and market challenges.

The Life Sciences Manufacturing Opportunities

The idea and goals behind Industry 4.0 include connecting human resources, data, and physical machines in a cyber physical network. Although the Life Sciences industry is quite advanced in its application of technology, Life Sciences manufacturing operations historically have been very cautious in adopting new technologies. With high costs to re-validate a working, licensed manufacturing process after making a change, the regulatory environment has historically been a major barrier. This alongside other drivers resulted in Life Sciences companies focusing on new product development and sales rather than on optimizing operations.

This traditional mindset is changing rapidly. The industry is facing strong price control pressures, the historic product lifecycle patent protection window is shrinking, and there are fewer opportunities for blockbuster products targeted at a large, uniform global market. As these pressures grow , manufacturing effectiveness, flexibility, and reliability have become critical enablers for the industry to meet challenges. Digital automation systems have the potential to fundamentally transform manufacturing, enabling stepchange improvements in performance. A great example is how single-use manufacturing processes and advanced digital solutions dramatically reduce the initial capital spending and improve ongoing manufacturing operations.

Source: American Productivity and Quality Center

To take advantage of opportunities, many companies are developing a strategic manufacturing operations roadmap to inform how they modernize and digitize their manufacturing operations. These multi-year plans can deliver sustainable agile operations as well as improved cost-efficiency and control to provide a competitive advantage ultimately leading to better care for patients. Two core areas offer significant opportunities as companies leverage the new processes and digital technologies: throughput improvements and manufacturing flexibility.

1) Throughput Improvements

In addition to having significant warehouse space costs, Life Sciences companies have significant amounts of working capital tied up in inventory. For example, to manage changing demands today, many companies keep an excess of 90 days of safety stock and have large amounts of intermediate and final product inventory with various quality statuses, but particularly those waiting on QA test results. Top quartile companies utilize real-time release (where an order is proven to meet specifications on completion of the order) to dramatically reduce this inventory carrying cost.

To provide real-time release, leading manufacturers are:
  • Moving lab measurements from remote laboratory locations that require slow sample management processes to atline or in-line production points with no time delays. The expanded interfacing capabilities of digital automation systems to new sensors and analyzers make this work possible.
  • Using the in-line lab quality information to automatically adjust the production line versus having to wait for lab results, make a "manual" decision, and then deal with all the production that occurred during the wait. Digital automation with embedded advanced control and integrated analytical measurements can help ensure quality.
  • Adding equipment monitoring and process modeling, so that digital automation systems can predict potential problems to avoid them before they occur.
  • Using manufacturing execution systems(MES) to confirm that equipment is properly calibrated and in the correct state, that people are properly trained, and that the proper sequencing of work activity is occurring to avoid deviations.
  • Leveraging embedded digital exception handling methods to confi rm that any deviations that do occur have been resolved quickly with no impact on release.
  • In addition to working capital savings, these techniques also reduce unit costs. Reductions in quarantined or lost product, reductions of in process material losses, and consistent batch execution all contribute to cost savings.
2) Manufacturing Flexibility

Production lead times in the Life Sciences industry typically have been considerably longer than lead times of other industries. But this is changing. The amount of exclusive time available to a company to produce a new drug is shrinking as generics and bio-similars get faster approvals. As target patient pools get smaller (fewer blockbuster medicines and more niche market medicines), manufacturing must be sized appropriately while also maintaining a global reach. Because the number of new products successfully completing clinical trials is increasing, more new products must go through the same supply chains faster.

Companies are addressing these issues by:
  • Adding supply-chain complexity via outsourcing to contract development organizations, contract manufacturing organizations, and global logistics organizations to lower capital risks and to make sizing and new manufacturing capital decisions much later in the development cycle.
  • Applying advanced planning, scheduling, and modeling techniques across the complete supply chain to optimize in-house facilities and contracted resources for a combination of best cost and faster deployment.
  • Utilizing new manufacturing processes like single use or continuous manufacturing with smaller capital footprints, faster deployment, and higher utilization so that a new facility can have footprint 60-70% of a traditional site yet still produce more product in a shorter period.
  • Developing modular, standards-based operations so that changing the manufacturing sequence and/or recipe for a new drug doesn't require new equipment or re-validating the complete process, only what's changed.
  • Ensuring consistent quality standards are maintained across these approaches by integrating the systems and leveraging their new modular standards so that crosssite comparisons can demonstrate consistent performance.
Life Sciences manufacturing leaders are using modern, digitized infrastructure and applications to leverage standard building blocks, to integrate information flow globally, to facilitate planning/scheduling, and to optimize their supply-chain performance. Using a mix of site-based and cloud-based applications provide the infrastructure to use consistent business processes and reporting to provide sustainable competitive advantages.

Through digitization, including cloud computing, companies can develop global integrated supply-chain networks. Cloudbased networks make it much easier to link all players through a single integrated network, even those with different IT architectures or ERP systems, thus making networks more scalable.

Associated improvements in manufacturing flexibility can give real capacity gains. All gains from the existing assets can potentially delay or remove the need for other (more expensive) capacity increase investments.

Advance Your Operations with the New Industry 4.0 Revolution

Life Science organizations of all sizes are taking advantage of technological capabilities in manufacturing while incorporating a holistic strategy regarding GxP compliance to ensure the value will be fully realized . Industry 4.0 is here. Companies now can leverage it to modernize technical operations and corporate quality management. Advanced technology solutions and Industry 4.0 can lead to productivity gains and can secure a company's competitive advantage, while also improving the robustness of product quality and the security of the supply chain to the patient.

We are amid the next industrial revolution and are seeing a radical revamping of technical operations from the inside out. Based on the common principles of Industry 4.0, an innovation initiative can significantly improve agility and productivity issues, and provide quality operations with better tools to enforce product safety and supply-chain security.