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 industry in such a short 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 many of us are the proof of their success. As you read this, the 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 modelling to reduce risks and establish a holistic, transferable control strategy.
Process development in the pharmaceutical industry now involves more data-driven decision-making and risk assessment than ever.
Industry time-to-market is as short as ever, 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 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 that are not separated in silos but communicate 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.
THE DIGITAL TRANSFORMATION
Laying the groundwork for digital transformation is no small endeavour, but the potential payoff is enormous. A factory that operates on a single source of data can perform deep real-time analysis, which enables it, in turn, to drive significant outcomes, such as a shorter time to market and less costly drug development. This leads to savings for consumers and society-at-large and better collaboration and data sharing between innovators and contract manufacturers.
A gradual change is occurring across the entire pharmaceutical ecosystem, including equipment manufacturers, software solution providers, and regulators.
This can also lead to a shift from scheduled maintenance to more efficient condition-based, and later, predictive maintenance strategies while offering a greater ability to identify phases or transitions in continuous processes and assign KPIs. Besides, companies can also expect increased visibility into product quality during the entire manufacturing process, not just at the end of the cycle.
THE JOURNEY TO PHARMA 4.0
From advanced analytics to artificial intelligence, 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 OEE or other KPIs, factories must work toward clear and measurable goals. Pharmaceutical companies are as prepared as ever to cross ambitious milestones thanks to new tools and technologies. 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 pressing problems. Increasing the number of people who can access real-time data will be a cultural shift for many companies. 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 abilities. 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 essential 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 the visibility that they didn’t have before?
After all, the people on the production floor understand the process best. These people will benefit from 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 at a certain pace. 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.
From advanced analytics to AI, numerous technologies have the power to transform the way pharmaceutical factories operate.
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 serves as a roadmap for the future and helps companies lay the proper 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.