Industry 4.0 is Here and Pharma Manufacturing Needs To Modernise To Keep Pace
Industry 4.0 is changing the face of manufacturing in almost every corner of the globe. Here’s how the pharmaceutical industry can make the most of these exciting new opportunities.
The world is presently going through its fourth industrial revolution, known as Industry 4.0. Mechanical production was the core tenant of the first industrial revolution, followed by mass production, then automation and computing. Now, Industry 4.0 is building on those foundations through cyber-physical systems and Internet of Things (IoT) connected machines which can communicate with one another.
The pharmaceutical industry has lagged somewhat behind in adopting Industry 4.0 practices, and in many ways is still not completely immersed in automation. However, those pharmaceutical manufacturers which can move towards Industry 4.0 practices the fastest are likely to gain significant advantages over their competitors.
“Although biopharma as an industry has lagged behind industries such as aerospace and electronics, we are learning from others and taking initial steps,” said Executive Director for Internal & External Manufacturing, Biologics, Global Technical Operations at Merck & Co, Francisco Leira. “The need to better connect information technology and operational technology systems, which may be different at various facilities, is a challenge. Another hurdle to be overcome is developing the capabilities of the workforce to use new tools and systems.”
Time to Act
An important factor which the pharmaceutical industry must consider is that technology is now on a trajectory of inexorable growth. Things are moving so rapidly that even the most gifted of industry prophets will find it impossible to predict what the technological landscape will look like more than just a few years into the future. However, it would be a mistake to allow the industry to be paralysed into inaction, waiting for an unachievable perfect jumping-on point.
One action which is crucial to take initially is to bring in new standards for these intelligent devices. The OPC Foundation and FieldComm Group are developing advanced standards for communication, with the International Organization for Standardizationand the International Electrotechnical Commission handling the same for data exchanges. These standards are essential for the compatibility of Industry 4.0 devices as, if everyone is singing from a different hymn sheet, there is no guarantee machines will end up speaking the same language.
One of the most potentially disruptive Industry 4.0 technologies is artificial intelligence (AI). With AI capable of deep learning, computers can run multiple scenarios at a rapid pace, and learn from the outcomes. Thanks to Cloud storage technology, the huge amounts of data generated can be easily accessed and made available to the wider industry.
AI-powered digital twins can be used to detect deviations or anomalies, as well as prediction and simulation. Digital twin technology creates digital representations of existing assets using advanced sensor data, and then applies certain conditions to learn from the results. In medicine manufacture, these conditions could include how different sized tablets affect breakdown schedules, or the likelihood of a patient developing certain side-effects. The digital twins can then learn and adapt as they discover new information.
AI could present an exciting new way of manufacturing drugs by running potential simulations, and using the data to drive design and development. However, there are potential issues inherent with the technology, especially when one considers the strict regulatory environment of the pharmaceutical industry.
“AI poses difficult questions from a regulatory perspective,” said Vice President of Advanced Analytics at GE Digital, Christopher Larkin. “If the algorithm which defines a product is constantly changing as learning increases, how do you define and validate the product? The pharma industry needs to think seriously about how AI will affect the industry and how this change can be managed.”
Being able to accurately define your product is a key step in the process of achieving regulatory compliance in the pharmaceutical industry, so new standards and procedures will need to be established to allow these technologies to be adopted.
Industry 4.0 presents both opportunities and challenges for the pharmaceutical manufacturing industry, and there is no one easy road to adoption. However, by implementing the correct standards and fully exploring the possibilities offered by emerging technologies such as AI and digital twins, the industry can find a way to move effectively into this new arena of manufacturing.
“Hopefully, companies, especially early adopters, will continue to publicise their technological advancements and report the associated gains to encourage wider adoption throughout the industry,” said Deputy Director of the Office of Testing and Research in the Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, FDA, Sau Lee. “The FDA and industry may need to take additional steps to address perceived regulatory uncertainty and facilitate further adoption.”
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