Why digital plants are the future of pharmaceutical manufacturing Deliver real world impact: faster speed to market, more agile processes, increased personalization—and more

Contents

Introduction 03 Defining the digital plant 04 The 5 advantages of digitalization for pharma companies

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Optimizing plant design 07

Boosting throughput 08

Greater agility 09

Achieving sustainability goals 10

Faster time to market 11

A 4-phased approach 12 Looking to the future 17 Summary 21

2Why digital plants are the future of pharmaceutical manufacturing

Introduction The past several years have taken manufacturing to the next level, handing processes over to technology, smart machines, and artificial intelligence (AI). These transformations often happen in isolation, creating siloed environments that miss the bigger purpose of digitalization. But when a company connects data among people, programs, and processes, the sum creates a digital plant or factory.

A digital factory represents far more than the physical process of making things: it’s a concept in which the factory or plant itself figures into the equation. The goal is to optimize both the manufacturing processes and the environment that houses them.

Powered by data connectivity, digital plants enable cross- functional coordination, create greater agility to adapt to the changing world, and give pharma companies a competitive edge. They are the apex of digital transformation for pharmaceutical manufacturing.

Embracing a digital culture and leading with a data-centered mindset01 Accelerating digital transformation across the organization02 Investing in cloud-based platforms to create common data environments03 Leaning into automation and digital processes to do more with fewer workers04

Taking the first steps are simple in concept, but, as in most manufacturing processes, complex in detail. They include:

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https://www.autodesk.com/products/fusion-360/blog/designing-and-manufacturing-with-intelligence-how-autodesk-ai-helps-you-be-more-efficient/ https://www.autodesk.com/design-make/emerging-tech/digital-transformation https://www.autodesk.com/products/fusion-360/fusion-cloud-manufacturing

Defining the digital plant A digital factory or plant is a shared virtual model of key plant characteristics—such as geometry, behavior, and performance— that displays the convergence of all digital networks in the facility and its operation. This digital representation compiles data from the structure, systems, assets, and processes, providing you with insights into how to plan, build, and operate your facilities; how to reconfigure them; and how to maximize the efficiency and productivity of every asset. Through a silo-free ecosystem you can achieve real-time collaboration, smarter decision making, and better outcomes:

• A connected ecosystem of internal and external stakeholders, including building engineers, contractors, production engineers and facilities management

• Plant or factory builds delivered on time and on budget through construction sequencing

• Predictive maintenance

Digital plants apply the same principles used to optimize the product-development lifecycle—thought leadership, systems, theories, and methods—to the lifecycle of the plant itself. They also allow pharma companies to simulate what-if scenarios to identify opportunities to upgrade the functions of the manufacturing environment.

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https://www.autodesk.com/design-make/articles/convergence-in-manufacturing https://www.autodesk.com/solutions/construction-sequencing-workflow

Make better products

Improve operational efficiency and sustainability

Speed up time to market

Attract more customers

Increase innovation

Gain actionable insights

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Companies rely on digital plants and factories to help them:

Their intuitive ecosystems are powered by data and enhanced by human ingenuity, helping you adapt to volatility and grow more resilient in the face of disruption.

5Why digital plants are the future of pharmaceutical manufacturing

The 5 advantages of digitalization for pharma companies Whether you’ve fully embraced your journey to digital transformation or are just getting started, you’ll recognize the need to be more agile and adaptable.

Digitalization gives you the tools you need to collect enterprise-wide data that is the foundation of resilience and growth opportunities, like:

6Why digital plants are the future of pharmaceutical manufacturing

Seven common areas of waste are often associated with manufacturing:

Optimizing plant design Digital plants support lean operations by eliminating redundant behaviors, consolidating workflows, and automating processes, resulting in lower costs and increasing time employees can spend on value-adding work.

The ultimate vision of a digital factory integrates everything and everyone—shop floor, building, infrastructure, suppliers, vendors, and stakeholders—creating a connected data flow. From that integrated foundation, you can automate, predict, and create a certain intelligence that maximizes efficiency across the entire operation.

With a digital plant, manufacturers can simulate alternatives to find more efficient ways of achieving goals.

Transportation Inventory

Motion Waiting

Overproduction Overprocessing

Defects

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Boosting throughput Demand for pharmaceuticals isn’t just increasing; it’s changing too. Personalized medicine is driving a transformation in pharmaceutical manufacturing, necessitating innovation and adaptability to meet the evolving healthcare needs of the populace.

With a digital plant, you can prepare yourself to meet this growing demand for personalized products, using small-batch runs, for example. Through digitalization, you can easily customize orders— making different design and manufacturing choices, while maintaining, or even increasing, throughput. And that’s a powerful competitive advantage.

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Greater agility As the past few years have shown, stability is never guaranteed. But even as the manufacturing environment continues to improve, pharma companies need to become even more agile, prepared for whatever disruption event may occur next, in the economy and the world.

Digital plants and factories enable flexible manufacturing. With smart machines, you can be more resourceful and quickly find alternative solutions to change course, make modifications, or adapt to new scenarios. If supply-chain problems disrupt your supply, you can switch to another approved supplier. With this flexible model, you’ll be able to minimize disruption while maintaining compliance.

9Why digital plants are the future of pharmaceutical manufacturing

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Achieving sustainability goals According to the World Economic Forum, the manufacturing industry as a whole generates 20% of global emissions and is responsible for 54% of the world’s energy consumption.

With a data-driven operation, you can uncover more insights that can help you meet your sustainability goals— defined by industry standards, EU or national legislation, or your own leadership. Some of your peers are even adding a sustainability role to the C-suite, dedicated to tracking performance metrics, spearheading green policies, and ensuring their company stays in compliance.

A digital plant facilitates more sustainable operations through technology:

Digital twins generate real-time actionable insights so owners can make more sustainable choices.

Generative design allows you to find environmentally friendly options (like raw materials) in the design and build of your plant and surrounding infrastructure.

Automated systems and AI track energy usage data (such as heat or cooling) within a space, based on human behavior.

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https://www.weforum.org/agenda/2020/01/factories-of-the-future-innovation-manufacturing/ https://redshift.autodesk.com/articles/digital-factory-planning/ https://www.autodesk.com/solutions/generative-design/manufacturing

Faster time to market Manufacturing plants have lifecycles, just as products do. To maximize productivity, the environment where the manufacturing happens needs to be optimized. And that’s the whole purpose of digitalization. Thanks to automation and a connected ecosystem, information moves faster in a digital plant than in traditional manufacturing.

When your plant is digital, you can leverage insights for a faster design and manufacturing process, iterate solutions, and make rapid decisions. The World Economic Forum found that the most digitally advanced manufacturing companies (a consortium it calls the Global Lighthouse Network) increase their speed to market by as much as 89%.

1 1Why digital plants are the future of pharmaceutical manufacturing

https://www3.weforum.org/docs/WEF_GLN_2021_Reimagining_Operations_for_Growth.pdf

A 4-phased approach Whether you’re building a new operation or reconfiguring an existing one, it’s important to follow a phased approach to creating a digital plant:

Plan01 Design02 Build03 Operate04

1 2Why digital plants are the future of pharmaceutical manufacturing

Plan Planning a digital plant begins with logistics and laying out the operation. Start by breaking down workflows step-by- step to determine each station location, equipment placement, and a configuration that maximizes productivity. If digital transformation is underway, you may already have an extensive library of items that can go into the factory.

As pharma manufacturing continues to increase in complexity, the people, processes, and technologies involved must become more connected than ever before. You’ll need a planning environment that provides visibility to every stakeholder to help you achieve greater budget and scheduling certainty.

With a common data environment (CDE) that connects teams across disciplines, you can capture every design, construction, and manufacturing decision from the beginning.

You can apply lessons from your last plant project to your current one, so everyone can learn. You can improve documentation of existing conditions, revealing potential risk areas. And you can better integrate the building envelope with the machines inside, increasing project predictability as well as potential cost savings.

1 3Why digital plants are the future of pharmaceutical manufacturing

Design After the planning phase, you’ll have a sense of the manufacturing framework as you begin to design the digital plant. Engineers determine how to lay the plan out in the physical space. They’ll simulate the movements of people, machines, and materials to determine the most efficient space allocation to eliminate bottlenecks for a faster time to market. Designers will also integrate suppliers and vendors into the digital coordination of the plant.

All stakeholders review the design to ensure its viability and validate that the layout will work. Virtual reality can bring the plant to life, helping stakeholders visualize the space and make revisions if needed. In the design phase, you’re aligning the design with the intent of the operation. This helps detect clashes and sort out any problems in advance, ensuring you’re working toward the best outcomes.

Any stakeholders in the project also need to pull from the same plan to design their specific area. This might include an ergonomics team that evaluates workstations or the HVAC team mapping the movement of air throughout the facility.

These plants are massive buildings with large machinery and many moving parts. A digital plan allows installation issues to be seen early, resulting in fewer errors during the build and operation phases, and faster path to operations.

14Why digital plants are the future of pharmaceutical manufacturing

Build Next up: construct the digital plant. This is a digitally orchestrated process, using technology such as building information modeling (BIM) to coordinate between multiple teams—architects, engineers, and contractors—and reduce the risk of cost and schedule overruns. A construction cloud platform creates a common data environment and a single source of truth for every stakeholder to work from.

Virtual reality can also bring the plant to life, helping stakeholders visualize the space and make revisions if needed, and uncovering clashes in advance, ensuring you’re working toward the best outcome.

With a detailed construction sequence, you can organize and streamline the build process. BIM tools coordinate logistics while visualizations simulate the layout to test and retest the movement throughout the space and workflows. When everything is installed in the plant, you connect all the stations together and power it up. Then, you ramp up production until you hit the output you need. The digital plant begins to generate a feedback loop with actionable insights.

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Operate Your digital plant is up and running, pulsing with data that flows freely among people, programs, and processes. You have a digital twin that sits on top of the physical asset, tying all the information together and allowing different programs and networks to communicate. This virtual representation gives you an overview of your entire operation and helps you see the impact of every decision.

Empowered with all your new information, you can continually optimize a facility for its entire lifecycle, even adjusting specific production runs. For example, if you discover you need 10% more product for a customer’s order, but you calculated only a 5% overage, you can refer to your virtual model to reorganize the production line and adjust the output.

Operation is responsible for approximately 80–90% of a building’s cost. A digital plant is designed to reduce those costs by delivering deep insights. Machine learning and automation can facilitate predictive maintenance, alerting workers to an issue before a piece of equipment malfunctions—and saving you from unexpected downtime, and keeps production moving without disruption.

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https://www.autodesk.com/design-make/articles/connected-data-for-owners?us_oa=dotcom-us&us_si=8a8f8742-ee13-47f2-8bcf-09f06c18f678&us_st=connected%20data%20for%20owners https://www.autodesk.com/design-make/articles/machine-learning-robotics https://redshift.autodesk.com/articles/digital-factory-planning/

Looking to the future According to a report on digital factories from PwC, companies that invest more than 3% of their net annual revenue in plant or factory transformation are 2.5 times more likely to achieve high returns than those who invest less than 2%. But what would a future with a digital plant landscape look like? Here’s a quick glimpse.

Making pharmaceutical manufacturing even smarter Right now, the concept of a digital plant is built around technology, machines, tools, and robots. But it all comes down to what these machines contribute: data. The future of digital plants and factories is converging data from multiple sources and asking, “What does this combined data reveal?” Connected data leads to more than smart manufacturing: It will create intelligent manufacturing. A smart factory or plant gives you the information to take specific action for optimizing your plant and achieving a certain quality. With intelligent manufacturing, the plant will use data to make decisions, too—like machines that can sense when something’s not right and course-correct independently.

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https://www.pwc.de/de/content/0f96ea9c-992c-4ba7-8c4d-b4637cf81d9f/pwc-digital-factory-transformation-survey-2022.pdf https://www.autodesk.com/design-make/articles/smart-manufacturing

Infusing pharmaceutical manufacturing with transparency Where will all this data live? On platforms in the cloud, where this live- action view enables 360-degree visibility of an operation. Besides simply breaking down silos, platforms will also become more powerful, extending beyond the walls of the digital plant, through technologies like digital twins and AI-powered insights, to support your entire operation.

Design and make platforms like the Autodesk Fusion industry cloud will provide a single source of project data across your organization and supply chain through a unified data model. By ensuring everyone has access to the same data, you can eliminate repetitive tasks and processes, accelerate productivity, and provide critical real-time insights about product development and business operations.

In addition, you can also extend that data environment to suppliers, vendors, contractors, and other stakeholders. This means they can all work from the same data, at the same time, creating the ultimate vehicle for collaboration. And as manufacturing-led companies increasingly become data-led organizations, these platforms will need to be built on a foundation of trust—providing a secure, reliable, resilient, and scalable solution.

1 8Why digital plants are the future of pharmaceutical manufacturing

Bridging the skills gap with automation Digital plants will change pharmaceutical manufacturing processes—and the nature of manufacturing jobs. And that’s a good thing. Right now:

Why is this happening? Workers reaching retirement age outnumber those entering the industry. The automated workflows inside digital plants and factories will help pharmaceutical manufacturers close the labor gap, allowing them to do more—more quickly—with fewer, highly skilled workers.

Over the next three to five years, many manufacturers will face an employee turnover rate of more than 10%, simply due to retirement.

10% At the current rate, 2.1 million manufacturing jobs will go unfilled by 2030 in the United States alone, costing the industry $1 trillion.

$1tn 70% of companies we talk to think that AI will drive significant or fundamental change in production and procurement to fill that gap.

70%

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Accelerating gains in sustainability Back in 2019, we asked manufacturers about their sustainability goals–and 52% confirmed that they had made those goals public. Two years later, that number increased to 75%. And according to PwC, today sustainability’s importance as a key driver of digital transformation has risen 150% year over year. But for some organizations, the gap between having a goal and achieving a real-world outcome can be quite broad.

Sustainable manufacturing can help you get there, through a systemic overhaul of industrial processes to analyze and reduce the amount of energy, materials, and transportation time and effort you spend on making products.

The process begins with data—analyzing supply chains, plant performance, real estate footprints, and transportation and logistics. On the shop floor, the rapid adoption of more automation and robotics can become a source of more efficiency. Adopting renewable power at pharmaceutical manufacturing sites can greatly reduce emissions.

2 0Why digital plants are the future of pharmaceutical manufacturing

https://redshift.autodesk.com/articles/digital-factory-planning/

The future is closer than you think Like many transformations, the move to digital plants and factories can be made incrementally while still delivering near- term impact. Pharma companies who choose to evolve their processes will recognize the benefits of a more data-centric approach throughout the design, build, and operation phases of the plant lifecycle and embrace change accordingly. The outcomes around design optimization, throughput gains, agility, sustainability, and speed to market will compound quickly.

Owners will have access to the exact information they need, when they need it. Business decision makers will be able to identify and respond to challenges before they happen. Production lines will become more resilient in an unpredictable world. And many pharma companies will be able to outthink—and outmaneuver—their competition.

As the pharmaceutical industry evolves toward fully digital plants, the decisions you make now—the approaches you choose, the technologies you adopt, the companies you partner with— will have tremendous impact in just the next few years.

With a robust foundation of integrated digital factory technologies—like layout and design toolsets, simulation, data and process management, digital twins, and more—Autodesk can provide you with the critical information you need to better design, build, and operate your facilities; to reconfigure them more quickly; and to maximize the efficiency and productivity of every asset throughout the lifecycle of your plant. All so you can meet today’s challenges—and be ready for tomorrow’s.

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Optimizing factory design Boosting throughput Greater agility Achieving sustainability goals Faster time to market Introduction Page 3 Optimizing factory design Page 8 Boosting throughput Page 10 Greater agility Page 11 Achieving sustainability goals Page 13 Faster time to market Page 14 A 3-phased approach Page 15 Looking to the future Page 19 The future is closer than you think Page 24

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