The pharma manufacturing facility of the future

April 10, 2024
The challenges are surmountable — and worth taking on to help build advantages

If building the pharma manufacturing facility of the future were easy, everyone would be doing it. In reality, there’s a lot to overcome — from regulatory requirements to commitments to sustainability, quality and the workforce.

However, as companies develop new facilities, they face difficult decisions: Take on the technical challenge of building fully automated, future-oriented factories, or embrace the simpler, less costly path of relying more on traditional factories indexed more on human labor.

It may be hard to weigh each path when considering your bottom line. But as an industry, pharma needs smart manufacturing facilities to grow sustainably into the future. Beyond just increased product demand, new personalized and gene-based therapies could pose supply chain challenges that random acts of digitization can’t solve alone. Plus, the persisting impacts of inflation put a spotlight on cost containment.

Now or soon, manufacturers should identify the ways technology can meet the industry’s sustainability, quality and workforce support needs, while meeting regulations and keeping medicines and therapies readily available for consumers.

The status quo — and the forces acting on it

COVID-19 spawned logistical and supply chain challenges that the industry has only started to address —especially as pharma manufacturers continue their quest for resiliency and agility. Speed to market as well as shifting product portfolios requires a responsive, agile and specialized supply chain (over the last two decades, the pharma industry has shifted from fewer large-volume products to many small-volume, high-mix products).

An intelligent, connected workforce plays a huge role in this. Because the manufacturing landscape is rapidly evolving with the integration of emerging technology, automation, robotics, AI, etc., reimagining how labor and talent are distributed can open the door to higher levels of efficiency and flexibility, especially when it comes to disruptions.

Organizations that connect their employees with their operations network through a digital backbone powered by data enables several advantages, allowing companies to track materials, remove bottlenecks and assign workers to tasks that enhance and optimize throughput and efficiency. With advanced smart manufacturing, organizations can even digitally distribute tasks across networks and factories. For instance, workers at a site in one country may require expertise of workers in another geography. By integrating augmented reality, virtual reality, digital twins and other technologies, workers can share knowledge and complete tasks irrespective of their actual location.

In addition to workforce considerations, pharma companies must also ensure that their facilities enable compliance with stringent and evolving regulatory requirements, with production of the highest quality products to ensure safety and prevent losses. While many organizations already use sensors, and near-real time dashboards and analytics to promote quality and curb losses, emerging technologies, such as Closed Loop AI-based control systems, high fidelity digital twin simulations, co-bots and automated handling solutions are further improving performance in the new factory floor.

Finally, reducing manufacturing impacts to the planet is top of mind, and implementing sustainability-driven technology investments must be the priority, without sacrificing efficiency. Smart manufacturing and investments in digitization can unlock ‘green’ commitments by improving overall equipment effectiveness, thereby reducing rework and scrap while making resource use more efficient. That means a move toward a more digital, automated operation can also be a move toward a greener one.

What to expect from the facility of the future

To bring a connected, state-of-the-art smart manufacturing pharmaceutical facility to life, it helps to understand what the facility of the future is and how organizations can get there. In the facility of the future:

  • Machines autonomously run entire production processes
  • Technologies such as robotics, data analytics, distributed ledgers, vision systems, augmented reality, virtual reality, AI, and the Internet of Things (IoT) all connect different operations, respond to new situations, and adapt because of these responses
  • Facilities are self-correcting via advanced sensors and detection systems, so as issues arise, data controls are in place to arrive at a solution
  • Process design expands beyond simply building four walls to assembling suites, equipment lines, utility lines, and every necessary component to support manufacturing — while construction may take six months, commissioning and qualifications can take up to a year, as each piece of equipment must be tested to meet engineering and manufacturing specifications

Pharma companies moving forward with their own facilities of the future should consider several ‘must-haves’ along the way.

Must-have 1: Fungibility

A manufacturing facility of the future should be adaptive to future changes. Generative AI can make flexible designs easier to create and implement by taking data about existing practices — what is used most, what is made most, where people spend time — to shape the layout of a new facility or equipment.

Once in operation, Generative AI can also accelerate time to value by applying knowledge and analysis consistently across production for continuous improvement. Beyond physical layouts, smart facility design can also anticipate future communications needs and provide networking infrastructures that can grow and adapt. The challenge is finding the right level of fungibility for each site, as certain choices provide more flexibility than others.

Must-have 2: Automation and transparency of material flow and task execution

In traditional plants, humans move raw materials, finished goods, and equipment. If a part needs to be replaced, someone must manually find, pull, and install it.

However, the back end should leverage a different set of movements augmented with advanced analytics. Automation and predictive maintenance can already handle such action-oriented and repeatable tasks, but digitization hasn’t been prioritized due to time constraints of constructing facilities. In future-focused construction, this should change. Leveraging technology to identify problems before they arise offers a new level of transparency, showing if a particular part is delayed or not available. Visibility into the end-to-end supply chain helps drive more informed decisions in response to geopolitical, natural or market disruptions.

Must-have 3: Scenarios and simulations

The facility of the future includes a digital replica, or digital twin, complete with command centers for scenario testing. This allows for a complete digital footprint of products from design and development through the end of the product life cycle — so companies can understand not only the product as designed, but also the system that built it and the way it’s used in the field. The digital twin also helps solve physical issues faster by detecting them sooner, predicting outcomes to a higher degree of accuracy, and designing and building better products.

Final thoughts

Pharma manufacturers already have plenty on their plates, and no one can say that anyone in this industry is shunning innovation. Pushing the boundaries on smart, automated facilities and processes might seem like a flight of fancy alongside day-to-day pressures. But these investments live right at the core of what the industry needs and the way it can shape a profitable future. Building the most advanced digital and AI capabilities into a new plant, or fitting them into an existing one, can unlock advantages in cost, production, workforce, compliance and other vital areas. The question will not be whether, but when.

About the Author

Laks Pernenkil | Principal & Practice Leader, US Life Sciences Product & Supply Operations, Deloitte

Dr. Laks Pernenkil is a principal and practice leader of Deloitte’s U.S. Life Sciences Product and Supply Operations practice, leading end-to-end supply chain, manufacturing quality, and technical operations consulting services.

He has more than 15 years of consulting and technical operations experience in the pharmaceutical, biologics, and medical device sectors. Pernenkil has a Ph.D. in chemical engineering practice from MIT and an MBA from MIT Sloan School of Management.