Towards pharma 4.0 – how digital transformation can optimise operations

The global population’s health has always depended on the pharmaceutical industry, but never so pointedly as it did at the height of the coronavirus pandemic. The world needed inoculations on a massive scale, and it needed them yesterday. Rarely is so much asked of an industry in so short a timeframe, and at such perilous stakes. In the face of this once-in-a-generation demand, vaccine producers became increasingly aware that they would need to reimagine their operations and embrace recent advances in process digitisation. We know how it turned out from there, of course, because a large share of us are proof of their success. As you read this, odds are good that you are either vaccinated or soon to be, thanks to the remarkably swift development of life-saving Covid-19 vaccines.

Process development (PD) in the pharmaceutical industry now involves more data-driven decision-making and risk assessment than ever. Under new PD models, companies use more data, automation, and modeling to reduce risks and establish a holistic, transferable control strategy.

Industry time-to-market is as short as it’s ever been, and development cycle times are shrinking. These process improvements prepare the industry to meet whatever unprecedented need comes next, meaning a safer, healthier future for all.

Factories of the future

In tomorrow’s factory, data drives action. While complex processes are underway, sensors and devices create a constant flow of data, resulting in both a real-time snapshot and digital history of the process. Data analysts and process managers can then use this digital history to create machine-learning approaches to machine maintenance and optimisation.

This is the vision of ‘plug and produce,’ a world of smart devices — not separated in silos — but communicating seamlessly across companies, partners, platforms, sites, and processes.

In the last few years, the International Society for Pharmaceutical Engineering has hosted a plug and produce working group — part of a larger initiative to implement Pharma 4.0 manufacturing concepts across the industry. Today, gradual and significant collaborative change is occurring across the entire pharmaceutical ecosystem, including equipment manufacturers, software solution providers, and regulators.

As more tools and solutions become available to support plug-and-produce manufacturing, businesses with enterprise-wide approaches to digital data will be able to integrate new equipment easily and move towards data-driven decision-making to optimise their operations and reduce costs.

Digital transformation

Laying the groundwork for digital transformation is no small endeavor but the potential payoff is enormous. A factory that operates on a single source for data can perform deep real-time analysis, which enables it, in turn, to drive major outcomes, such as:

• Shorter time to market
• Less costly drug development, potentially leading to savings for consumers and society-at-large
• Better collaboration and data sharing between innovators and contract manufacturers
• A shift from scheduled maintenance to more efficient condition-based, and later, predictive maintenance strategies
• Greater ability to identify phases or transitions in continuous processes and assign KPIs
• Increased visibility into product quality during the entire process of manufacturing, not just at the end of the cycle

The journey to ‘Pharma 4.0’

From advanced analytics to artificial intelligence (AI), numerous technologies have the power to transform the way pharmaceutical factories operate. By taking small steps, manufacturers can use new techniques to meet Pharma 4.0 standards, increase throughput, and reduce cycle times while maintaining product integrity.

Define goals

The factory of the future will be shaped by business goals and priorities. Whether they are OEE or other KPIs, factories must work toward clear and measurable goals. Thanks to new tools and technologies, pharmaceutical companies are as prepared as ever to cross ambitious milestones. By setting a combination of short- and long-term goals, and aspiring to stretch goals, companies can push the boundaries of what’s so far been possible.

Match culture and technology

Meeting Pharma 4.0’s new standards for quality management requires a team effort. The factory of the future demands an engaged workforce, including everyone from CEOs to workers on the shop floor. To be fully engaged, stakeholders need access to process data in real time. Access to real-time data gives stakeholders critical insights into their operations, enabling them to solve critical problems. For many companies, increasing the number of people who can access real-time data will be a cultural shift. But, by giving every user the autonomy to make decisions, manufacturers can empower more of their people to bring real, beneficial change.

Focus on people and capabilities

Transforming a factory with people and technology requires a team with the right technical capabilities. Whether that’s a technical team to plan and deploy new systems or the end-users who ultimately adopt them, it’s important to build teams of trained individuals capable of pioneering new strategies.

Close the loop on the production floor

When working towards factory-of-the-future goals, it’s important to pay attention to the people on the production floor. It’s about more than just seeking user adoption; organisation-wide, workers need to understand how technology and process changes will benefit them. Will it make their jobs easier? Will it give them visibility that they didn’t have before?

After all, it’s the people on the production floor who understand the process best. These are the people who will find the most benefit in this new data, and the new insights it affords. Pharmaceutical companies need the feedback and expertise of their subject-matter experts to create connected strategies that serve the bottom line.

Plan big, execute small

Manufacturing facilities have natural constraints and can only scale so quickly. Although it’s tempting to jump on every new process, procedure and tool right away, meaningful transformation can’t happen overnight. Planning a series of modest, incremental steps allows an operation to measure its success and make modifications along the way.

Starting small, though, doesn’t mean you can’t plan big. Reaching the factory of tomorrow will require a big-picture approach that prioritises enterprise architecture, basic infrastructure, and scalability. A long-term plan not only serves as a roadmap for the future, it helps companies lay the right groundwork on which to build.

For the first time, pharmaceutical companies are democratising data and insights to streamline processes, increase efficiencies, and create advanced cures in a shorter amount of time. With the help of the right tools and change management strategies, 4.0 philosophies can drive true organisational transformation.

Perry Zalevsky is the senior director, industry at AVEVA

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