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The future of pharma: How Industry 4.0 is driving pharma manufacturing

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Amin Sikander, Synkrato co-founder & president, examines the trends within pharma manufacturing that will incur as its processes become smarter, more data-driven and transparent.

Key insights:

Conversations around the fourth industrial revolution, commonly known as “smart factory” or “Industry 4.0,” have been sweeping the globe, and manufacturing processes powered by artificial intelligence (AI), augmented reality (AR), robotics, internet of things (IoT), and the metaverse are now a reality for the pharma industry.

In 2022, a large pharmaceutical company announced a new smart manufacturing site in the UK, and multiple pharmaceutical companies already leverage IoT devices to ensure that medication is transported and stored under safe ambient conditions.

What pharma can expect from Industry 4.0

The fourth industrial revolution focuses on connecting all business details through digitalisation using cloud or on-prem solutions. In a smart factory, all functions and processes are connected, providing transparency across teams and processes, including sales forecasts, ordering raw materials, machine maintenance, floor plan operations, reporting, and last-mile delivery. The team ordering raw materials can access AI sales forecasts and adjust orders accordingly. Operators can access the same sales forecasts and adjust production line speed to avoid client stockouts. Likewise, when forecasts predict fewer incoming orders, maintenance can seize the opportunity to run machine maintenance.

Creating smart manufacturing starts by identifying which areas in the manufacturing process should be digitised first; not all pharmaceutical companies have the same digital maturity and needs.

New pharma trends are emerging as processes and functions become interconnected, we review some of these trends below.

Increased patient safety

Patient safety has always been a focus for the pharma industry, so any technology that can reduce patient risks is important. Patient safety continues to be an Industry 4.0 technology driver. Drugs must be stored and transported under certain conditions to ensure product quality. Changing ambient temperature, humidity, light, or air can contaminate raw materials and the final product. IoT sensors - an Industry 4.0 solution - were designed to track small ambient variations and have become a key player in patient safety. They can aggregate real-time data and transfer it to a centralised data hub, usually accessed by a group of users to monitor and take action to protect patients.

End-to-end product traceability

Product traceability goes from ordering raw materials to last-mile delivery. New track-and-trace systems and serialisation solutions introduced in Industry 4.0 create additional transparency for pharma manufacturers, suppliers, and last-mile players to track every stage of the supply chain.

Product traceability has also been supported by the new DSCSA regulation that goes into effect by the end of 2023 and by new technologies like cloud labelling solutions and blockchain technology.

Pharmaceutical companies can leverage label management solutions to adhere to new label requirements. These solutions allowed working in a central platform to review, approve, and track labels across the supply chain. In a product recall, for example, pharmaceuticals know when and where a label was printed and can quickly locate the product batch. Blockchain will also be a key player in keeping drug batch records as specified in the DSCSA for at least six years.

Predictable pharma manufacturing issues

Predicting what could go wrong, when, and perhaps most importantly, how to avoid things going wrong, is the desired outcome for any manufacturing floor. Industry 4.0 provides pharma with new ways to analyse previous, current, and future production conditions to predict outcomes using AI. Companies can run what-if scenarios to reduce downtime, streamline production lines with new operations, and test new facility layouts, for example.

Reshaped workforce

As manufacturing facilities become more autonomous, human involvement will be reshaped. AI can be used to predict machine failure points before failures occur and trigger maintenance processes to reduce risk, removing the need for an operator to check on equipment. Instead, an operator’s new role will be to connect all the technical processes and ensure data is transferred correctly. Humans won’t be replaced by technology, but roles will evolve as technology use is widely adopted.

Protected manufacturer reputation

One of the challenges pharma has faced is counterfeit medicine, which affects patient safety and the manufacturer’s reputation. Using blockchain, another technology that is part of the fourth industrial revolution, manufacturers can add a new level of transparency to avoid being impersonated.

For example, perhaps Company X has manufactured a new drug. During the manufacturing process, a QR code to combine all the product properties is created and securely stored using blockchain. As the drug moves down the supply chain with its QR, parties add information, origin, destination, method of transportation, and so on. When the product reaches the consumer, he or she can use a QR enabler to access this information to confirm that the product is legitimate.

A late or poorly managed product recall is another item that can damage a pharma manufacturer’s reputation. In the last ten years in the US alone, more than 15,000 products have been recalled. Costs vary depending on the complexity of the recall, but according to Mc Kinsey, the average in 2010 was $600m per recall.

In the pharma industry, drugs go through multiple trials and tests, the results of which must be shared and approved. Blockchain provides secure sharing of highly sensitive information. If a product anomaly is detected, like a counterfeit drug, a recall can be done even before the counterfeit enters the supply chain, thereby protecting the brand’s reputation and patient safety.

A holistic view of pharma manufacturing operations

The items discussed above create a holistic view of pharma manufacturing. Pharma’s highly regulated environment requires a high level of expertise and oversight at every production stage. In the past, these processes created data silos, scaling difficulties, and inefficient operations.

Industry 4.0 connects all stakeholders to create new levels of transparency, operations control, quick, informed decision-making, and an autonomous floor plan. Removing data silos reinforces data-driven decisions across an organisation, giving everyone access to the same validated data. Smart factories will allow pharma manufacturers to adapt to market and regulatory changes without putting patients at risk, while they become flexible and competitive by sending information to the right person at the right time.

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