From Industry 4.0 To Pharma 4.0

By David Smaldone

Digitalization continues to have a huge impact on everyone’s life. As we go from home to work, several digital devices help us get through the day, ensuring we remember important appointments, helping us keep our health under control, or even saving our lives with the new safety systems embedded in our cars.

Since 2012 when the term “Industry 4.0” was first used, we’ve seen a steep technological adoption curve within different industries that use new technologies to improve efficiency, better control processes, enable early detection of potential problems, and reshape the human-machine interaction. The wealth of possibilities of this new industrial revolution is changing the way companies work and is setting the bar for competition on the global market for the next decade or longer.

Historically, the biopharmaceutical industry has been a follower as it pertains to these kinds of disruptive changes. Throughout the industrial revolutions of the steam engine, science and mass production, and digital technology, biopharma has lagged approximately 10 years behind other industries. That’s mostly due to the complexity of the business and the high standards and rules that companies must follow to ensure patient safety. But it’s those same high production standards and increasingly tougher regulatory pressures that are making today’s biopharma companies realize that to stay competitive, change is inevitable.

A FASTER ADOPTION THAN EVER BEFORE

Data integrity and serialization are just two examples of how technology shouldn’t be considered simply as a means for improving efficiency but as an enabler of critical processes such as research, production, and logistics. This is maybe why for the first time in history the pharmaceutical industry has been fully impacted by the fourth industrial revolution; only a few years are separating our industry from other historically more technology-oriented sectors (e.g., automotive).

There are several covenants and restrictions that do not make adopting Industry 4.0 technologies/concepts easy for the biopharmaceutical industry. For instance, each founding element of the Industry 4.0 paradigm needs to be fully assessed and adapted to the specific needs of this highly regulated industry. CFR 21 Part 11 compliance needs to be embedded into the digital and technological solutions impacting product development and production. Further, working in controlled environments often prevents the full use of innovative technologies such as cooperative robots in their out-of-the-box configuration.

Most of the large and midsize biopharmaceutical companies have started an Industry 4.0 journey that will significantly transform many of their core processes, including production, quality control, and quality assurance. While this is an individual journey, the starting point is based on each company’s history, level of automation, and digitalization.

THE PHARMA 4.0 SPECIAL INTEREST GROUP

Industry 4.0 also has the potential to transform the entire industry. Therefore, it makes sense that companies will join together to try to drive the broader change affecting the pharmaceutical space. In fact, that’s the main objective of the Pharma 4.0 Special Interest Group that the International Society of Pharmaceutical Engineering (ISPE) has created. ISPE is an international nonprofit organization that brings together more than 18,000 pharmaceutical and biopharmaceutical professionals from 90 countries. The ISPE Pharma 4.0 SIG has been working for more than two years on shaping the Pharma 4.0 concept and on providing tools, methods, and applications that could help pharma companies drive 4.0 change.

The SIG has been working closely with ACATECH, the German Academy of Science and Engineering (one of the main contributors to the initial definition of Industry 4.0 concepts) and other national and international institutions and academia, in order to define the founding elements of the Pharma 4.0 operating model.

The model is composed of the following four elements that are equally important and that should be all addressed at different points within each company’s 4.0 journey:

• RESOURCES: The “H-factor” — the contribution of human capital — is essential to the success of a Pharma 4.0 program. Not only will the skills and competencies of employees need to be adapted and updated, their full cooperation will be necessary. After all, the implementation of Pharma 4.0 technologies will allow people to focus on value- added activities, leaving repetitive operations to machines. Thus, the availability and qualifications of a company’s resources is one of the key success factors in a 4.0 transformation.
• INFORMATION SYSTEMS: ERP, MES (manufacturing execution system), and LIMS (laboratory information management system) have been present in companies for years and are, therefore, not indicative of “innovation.” With Pharma 4.0, though, these systems will need to interact in a holistic value network in which end-to-end traceability will be a key factor driving integration. Interconnectivity and interoperability throughout all levels of drug development will enable data collection and process control.
• ORGANIZATION AND PROCESSES: As you would expect, in order to support the implementation of new Pharma 4.0 technologies, processes — and sometimes even organizations — will have to be changed. Being able to move from a silo- based organization to a value-stream-oriented company with functions cooperating across the different phases from product development to commercialization will be a necessary change that companies will have to manage. This will enable moving from a manufacturing control strategy to a holistic control strategy, making a number of synergies possible within the organization and, therefore, enabling increased quality and regulatory compliance.
• CULTURE: Pharma 4.0 will provide people at various levels in an organization with new tools that will enable real-time process monitoring and foster evidence-based management. Culture encompasses a company’s value system and is one of the key elements in driving change. A company’s culture will have to adapt and evolve in order to cope with the challenges of a Pharma 4.0 transformation.

WHAT’S YOUR LEVEL OF DIGITAL MATURITY?

These four elements are supported by two enabling factors, the first of which is digital maturity. We mentioned earlier that each company embarks on a 4.0 transformation program based on its history and experience. Assessing the current digital maturity of a company will help you determine the starting point of the 4.0 journey and define what steps are necessary to implement Pharma 4.0 technologies. As part of the activities of the ISPE Pharma 4.0 SIG, a maturity model is being developed that could be used to assess the initial digital maturity of an organization and to periodically monitor its progress.

Data integrity by design is the second enabling factor of the ISPE Pharma 4.0 operating model, ensuring the compliance and the reliability of information and data being exchanged across the value stream. When designing new processes or changing existing ones, data integrity by design should be one of the driving factors of the change.

The Pharma 4.0 operating model provides the framework on which new 4.0 technologies will be implemented, and it outlines the key elements that will have to be considered in a 4.0 program. As we’re entering a period of significant technological change for the industry, being able to rely on foundational concepts becomes even more important to achieving each biopharma organization’s objectives.

DAVIDE SMALDONE is corporate demand manager at Italian pharma The Menarini Group.