Building The Biopharma Manufacturing Facility Of The Future Requires A Phased IT/OT Strategy

By Rohit Harve, Jamison Roof, and Erik Moen, PA Consulting

Between 2018 and 2023, the number of biopharma manufacturing facilities in the U.S. grew by over 50%. Amid recent tariff threats, pharma companies are investing even more heavily in U.S. manufacturing. Collectively, 11 top pharma companies are investing nearly $230 billion in expanding their domestic footprints, including building more than 25 new manufacturing facilities and upgrading existing plants over the next five years.

To drive the greatest value from these investments, pharma companies must ensure that they are investing in “facilities of the future.” These facilities are designed not just to meet immediate manufacturing needs but to scale and evolve as new technologies reach the market.

While this may seem like a costly and daunting endeavor, this article outlines actionable steps for pharmaceutical companies to achieve digital facility operations and successfully build their own facility of the future.

Adopting A Digital Framework

Many pharma companies are eager to adopt advanced digital capabilities, but they often treat information technology (IT) — which manages data, analytics, and enterprise systems — and operational technology (OT) — which controls and monitors physical processes — as separate domains. This siloed approach leads to inefficiencies, integration challenges, and missed opportunities for innovation.

Instead, pharma companies must integrate a phased IT/OT strategy into the initial facility design:

• Smart customer: The expectations of consumers are changing rapidly. Predictive KPIs to drive business insights and self-optimizing workflows help manufacturers anticipate demand, streamline fulfilment, and deliver tailored products with shorter lead times.
• Planning: Integrated IT/OT planning systems connect demand signals with production capabilities, enabling dynamic scheduling and resource optimization. AI-driven planning tools and real-time data visibility support faster responses to market changes while minimizing waste and operational costs.
• Sourcing: Stronger IT/OT alignment across the supply network reduces cost and risk and becomes a source of shared innovation. Leveraging intelligent cross-system orchestration and automated data governance mechanisms can help improve integration across supplier infrastructure, while AI-based threat detection can bolster IT security.
• Manufacturing: The convergence of IT and OT through increased levels of automation and intelligence embedded into production systems bolsters performance and increases agility. AI-based batch release and predictive maintenance rely on real-time data integration between enterprise systems and shop floor equipment, allowing for faster decision-making and reduced downtime.

This strategy ensures that manufacturing systems and workflows leverage the strengths of both IT and OT, allowing pharma companies to unlock value sooner and achieve manufacturing excellence.

For example, a leading pharmaceutical company is developing a digitally enabled high-volume manufacturing facility capable of delivering 20 million doses annually within four years. We have worked with them to design a phased IT/OT strategy that will enable a connected facility at launch and scale to predictive operations over time.

Benefits Of A Phased IT/OT Strategy

Successfully designing and implementing a phased approach will result in four key benefits:

Saving Time And Money

IT infrastructure affects OT infrastructure and vice versa. Building the physical infrastructure before considering the digital infrastructure often leads to expensive and disruptive retrofits to integrate systems post-construction. By identifying IT and OT needs from the beginning, design teams can ensure that critical infrastructure (such as cabling, network nodes, and server rooms) are correctly sized and located, ultimately saving money and time.

Referring back to the previous example, this project has focused on aligning the IT and OT requirements early in the facility design process. This has allowed the teams to define the architecture, technology stack, and use cases needed to support the pharmaceutical company’s ambition for low-cost, high-efficiency operations, reducing the risk of future rework.

Easing Financial Risk Through Staged Investment

Building a manufacturing facility is a significant investment, requiring up to $2 billion. Amid cost pressures and market uncertainty, pharma companies may be hesitant to approve such a large up-front budget for a project that typically takes five to 10 years to deliver value.

One frequently overlooked benefit of a phased IT/OT approach is that it allows organizations to sequence investments. Budget is proposed in more manageable increments, with greater opportunity to align the investment to operational priorities and demonstrate value realized from previous phases. This lowers financial barriers and reduces risk.

It is essential in this process to define operational milestones to support phased capital investments, reducing risk and laying the foundation for future innovation.

Enabling Progressive Validation And Operational Excellence

The use of generative AI in biopharma operations presents a gray area regarding AI and other technologies in regulated environments. A phased IT/OT strategy allows companies to implement core systems (such as manufacturing execution systems [MES], laboratory information management systems [LIMS], and basic supervisory control and data acquisition [SCADA]) for initial operations, then scale up to more advanced capabilities like digital twins, predictive maintenance, and AI-driven automation.

As new capabilities are implemented, IT/OT integration planning supports rapid troubleshooting, robust compliance, and real-time decision-making. Furthermore, each phase is validated before moving to the next, minimizing start-up risk and regulatory complications.

Pharma companies should structure their strategy in phases. Focus phase one on a connected plant with integrated MES, LIMS, quality management system (QMS), and enterprise resource planning (ERP) systems, real-time data capture, and foundational cybersecurity. During phase two, outline the path to predictive operations, including AI-based batch release, predictive maintenance, and autonomous planning.

Mitigating Cybersecurity Risks

Increasing IT/OT connectivity drives operational efficiency but also can increase cybersecurity risks. A phased IT/OT strategy ensures that cybersecurity is integrated throughout the process, from designing to building and operating the facility.

Embedding advanced technologies such as Oakdoor, Google Cloud, and Amazon’s AWS for secure data diodes and GMP-compliant cloud solutions into the facility’s digital and physical architecture supports effective network segmentation, secure remote access, and rigorous data integrity from the outset. Ultimately, this approach fulfills both GMP and enterprise security requirements and protects critical data sets and processes from cyberattacks, while helping to comply with cyber regulations such as NIS2.

Building A Facility Of The Future

There are several steps that pharma companies can take toward creating their own IT/OT strategies and building facilities of the future:

• Engage stakeholders early: Bring IT, OT, operations, and quality teams into facility design workshops from the outset to drive cross-functional buy-in.
• Define your target digital maturity: Leverage a digital maturity model to determine where you want to be for facility opening and where you want to aim for future phases, ultimately ensuring that your IT/OT strategy can accommodate future digital innovations.
• Phase your architecture: To improve capital planning and support progressive validation, specify infrastructure and systems that can grow from foundational connectivity and compliance to a fully predictive plant.
• Validate as you go: Use milestones that correspond to maturity phases and make sure each level is delivering value and ready to scale before moving to the next phase, reducing financial and regulatory risk.

Companies that treat digital infrastructure as an afterthought often face rework, higher costs, and slower value realization. In contrast, a phased IT/OT integration strategy aligns every aspect of facility design and start-up to digital goals. This saves time and effort, accelerates start-up, and positions facilities to thrive in the future of pharmaceutical manufacturing.

Plan early, phase wisely, and let the digital infrastructure grow alongside the facility. The result is a plant that's not just ready for today's requirements but built to evolve with future innovations.

About The Authors:

Rohit Harve is an advanced manufacturing & supply chain expert at PA Consulting. He leads transformative initiatives, from continuous improvements to process scale-ups, leveraging advanced technology such as process mining and automation. His work spans greenfield facility planning, supply chain innovation, and driving operational excellence. With a commitment to creating meaningful change, he helps organizations navigate complexity and achieve sustainable growth.

Jamison Roof is a digital and data leader at PA Consulting. He has successfully delivered complex system integrations, custom software solutions, and digital modernization programs across the pharmaceutical, healthcare, and energy sectors. He excels at aligning IT strategy with business goals, driving innovation through emerging technologies, and ensuring operational excellence through robust architecture and governance. He applies his deep expertise in digital infrastructure, data platforms, and cross-functional leadership to organizations seeking to scale, secure, and future-proof their technology ecosystems.

Erik Moen is a healthcare & life sciences expert at PA Consulting. He supports clients across the healthcare ecosystem with digital- and data-related initiatives. He brings a background in communications along with insights from his work in healthcare technology to help pharmaceutical and biopharma clients unlock the value of real-world data and drive digital innovation.