The life sciences manufacturing industry is transforming faster than ever. Global reshoring, evolving regulatory expectations, talent shortages, and growing sustainability pressures are reshaping operations in ways that require organizations to remain highly adaptable. Leaders today are tasked with delivering state-of-the-art cGMP facilities faster, smarter, and more sustainably to be prepared for long-term resilience and performance. An example of this is from March 2025, where Johnson & Johnson announced $55 billion+ U.S. investments over 4 years, including creation of four new plants to increase their manufacturing capacity.1
Manufacturers who can capitalize on this opportunity will be those who pair bold strategic planning with trusted technology, deep domain expertise, and AI-enabled intelligence, before breaking ground. This blog introduces the New Capacity perspective from Rockwell Automation. It is built around five strategic priority areas to help life sciences organizations build future-ready cGMP facilities and thrive through uncertainty.
As pharmaceutical manufacturers try to bring their new capacity projects quickly online and begin to produce drugs to maximize patent exclusivity, there’s a huge incentive for them to build a Facility of the Future to minimize human capital needs and be agile and flexible from the get-go. Simultaneously regulatory bodies are encouraging increased automation and digitization, with a nod to the exploration of AI to improve quality and efficiency. Recent FDA guidance on Remote Regulatory Assessment of sites, Computer Software Assurance, and the planned use of AI in bringing efficiency to new drug application review process indicates an agency that is encouraging a traditional and conservative industry to evolve its digital maturity.
The Opportunity to Design and Build Future-Ready and Future-Proof Facilities
Reshoring initiatives and global investment in biopharma manufacturing continue to rise, creating demand for accelerated facility builds. But the challenges are significant:
- 95% of life sciences capital projects miss cost or schedule targets2
- Ground-up cGMP facilities typically take 3-5 years and hundreds of millions of dollars or more to bring online
- Talent shortages threaten scale and operational readiness, with 7.9 million workers needed by 20303
- Sustainability expectations and environmental regulations are intensifying. 95% of the top 20 pharma companies have defined targets to reduce their greenhouse gas emissions4 in response to tightening global climate regulations
As organizations enter 2026, leaders are emphasizing accelerated delivery, digital transformation, workforce evolution, sustainability, and regulatory agility. These topics closely mirror the pillars shaping the Rockwell Automation New Capacity perspective for building future-ready facilities.
Five Strategic Priorities for Future-Ready cGMP Facilities
The following priorities help manufacturers remain competitive, reduce risk, and scale new facilities efficiently over time.
1. Speed Time to Market Through Early, Strategic Partner Engagement
Opening a facility on or ahead of schedule unlocks value—improving competitive posture, strengthening stakeholder confidence, and enabling earlier revenue. Achieving this requires early collaboration with a qualified automation and technology partner during conceptual design, enabling alignment on control strategy, data architecture, and long-term operational flexibility. Early engagement means involving partners before detailed design begins, ideally at the conceptual design phase. This verifies decisions made upstream like equipment strategy, automation platforms, and data models support scalability and compliance downstream.
Rockwell Automation enables accelerated timelines through capabilities such as:
- Digital twin technologies that support system simulation and virtual commissioning
- Standardized engineering frameworks and integrated design environments for control systems
- Connected tools that streamline technology transfer between R&D and manufacturing
Organizations that take this early-engagement approach are already realizing significant gains. For example, a North American biotechnology company facing tight schedules partnered early with their automation and process design teams around a skid‑based standardization strategy using ControlLogix® controllers and a PlantPAx® system. Because alignment spanned architecture, skid strategy, and validation readiness from the outset, the team cut commissioning time by 50%.
Similarly, Cytiva strengthened its readiness by adopting standardized digital libraries, integrated analytics, and automated testing environments. With these tools driving consistency across its operations, the company achieved 10–20% throughput increases and notable reductions in batch release time, downtime investigations, energy usage, and material waste. These improvements translated into faster launch readiness for new products to enter the market.
2. Improve Operational Efficiency with Flexible, Integrated Infrastructure
Operational efficiency is essential for recouping large capital investments. But in complex facilities running on disconnected systems, inefficiency compounds quickly. Rockwell Automation Integrated Architecture® helps create a unified, flexible automation backbone that scales and evolves with the facility. Beyond the architecture and automation benefits, organizations are beginning to use AI-supported insights to better understand process variability, identify emerging bottlenecks, and guide continuous improvement efforts in real time.
Benefits of Integrated Architecture include:
- AI-supported predictive analytics to help improve plant and maintenance operations
- Faster access to meaningful, contextualized operational data
- Plug-and-Produce capability to seamlessly integrate and rapidly commission multi-vendor OEM equipment with minimal integration
- Lower total cost of ownership through solutions and design approaches that simplify validation and lifecycle management
These aren’t conceptual improvements—they’re what manufacturers are achieving today. These themes closely aligned with discussions at the ISPE Facilities of the Future Conference, where leaders stressed modernizing automation architectures and breaking down data silos in both new and legacy facilities.
At GSK, teams modernized aging EMS/BMS systems and consolidated their disparate control automation systems onto PlantPAx—an application of Integrated Architecture principles. This resulted in boosted reliability, visibility, and compliance while minimizing production risk.
3. Empower your Workforce with Digital Enablement Technologies
Workforce shortages continue to challenge life sciences manufacturers, making digital workforce enablement a strategic necessity. Technology can dramatically improve readiness, safety, and productivity. Manufacturers are beginning to layer in machine learning supported operator guidance systems that provide context-aware prompts, reinforce SOP adherence, and help reduce troubleshooting variability. This in-turn supports workforce consistency as teams scale.
Rockwell Automation supports workforce empowerment with:
- Immersive training and remote collaboration tools
- Digital work instructions to standardize execution and reduce errors
- Mobile access to workstations and real-time data
- Visualization tools that improve operational visibility
The impact on productivity and readiness speaks for itself. The pharmaceutical company Dong-A ST adopted Manufacturing Execution Systems (MES), Warehouse Management System (WMS), Supervisory Control and Data Acquisition system (SCADA), and PTC solutions from Rockwell Automation. This implementation helped to validate quality, data sorting, and analysis of the manufacturing environment which enabled decision-makers to make more immediate business decisions and decrease human errors within regulatory reporting and compliance.
The strong focus on workforce transformation at the ISPE event further validated that digital enablement is no longer optional—it’s a differentiator.
4. Consider Sustainability Objectives from Day One
Sustainability expectations are rising quickly, and greenfield facilities offer the best opportunity to introduce energy-efficient systems, optimize resources, and reduce environmental impact without costly retrofits.
Rockwell Automation supports sustainability through:
- Reduced consumption of power and utilities via the unified process and power control capabilities
- Energy and utility optimization with emissions insights powered by AI forecasting models
- Tools that track WAGES (water, air, gas, electricity, steam) consumption
And when sustainability is embedded into system design—not bolted on later—the performance benefits become immediately clear. A high‑speed centrifuge project demonstrated this firsthand. By implementing regenerative drive solutions and stabilizing surrounding operations, a pharmaceutical facility achieved 22% energy savings during peak operations, all while maintaining continuous operation of other devices and improving overall manufacturing stability5.
5. Maintain Regulatory Compliance with Agile, Connected Systems
Regulatory expectations continue to evolve alongside advancements in digital technologies, manufacturing processes, and global supply chains. Compliance must therefore be designed into the operational fabric of new facilities. AI‑supported quality‑monitoring tools, such as multivariate deviation detection and automated batch comparison, are beginning to support QA/QC teams by highlighting trends earlier and strengthening documentation accuracy
Rockwell Automation enables compliant, agile operations through:
- Electronic batch records and digital workflows
- Unified digital thread that supports traceability and audit readiness
- Virtual design and testing to reduce operational risk and support risk-based strategies
This integrated approach to compliance produces measurable outcomes across global operations. One biopharmaceutical company deployed a FactoryTalk® PharmaSuite® solution, enabling standardized processes, real time quality verification, and improved reporting – reducing batch cycles times from 10 to 8 weeks and producing an additional two batches annually.6
A Partner Built for the Realities of Life Sciences
Choosing a partner for a new life sciences facility isn't simply about selecting automation technology—it’s about aligning with an organization that understands the high stakes, highly regulated, deeply interconnected nature of modern cGMP operations. Rockwell Automation stands out because it brings together industry insight, integrated technologies, and long-term partnerships in a way few others can.
A Partner Who Understands Life Sciences Complexity
Rockwell Automation teams work inside the complexities of pharmaceutical and biotech manufacturing every day, understanding how early design decisions influence long‑term quality, training, reliability, and regulatory success. This operational and regulatory awareness helps organizations avoid costly misalignment and build facilities that perform from day one.
End-to-End Technology Designed to Work as One
The Rockwell Automation portfolio —PlantPAx® system, PharmaSuite® Manufacturing Execution System (MES), ThinManager® solutions, FactoryTalk® Design Hub™ software, Emulate3D® software, and more—is intentionally designed to interoperate by using Integrated Architecture. This reduces integration challenges, strengthens data integrity, accelerates validation, and maintains consistent workflows across engineering, operations, and quality.
Increasingly, AI‑enabled analytics are paired with these systems to enhance decision‑making, improve cross‑system contextualization, and provide deeper visibility into process behavior.
An Ecosystem That Reduces Risk and Accelerates Delivery
The global network Rockwell Automation has of OEMs, system integrators, and technology partners aligns around common architectures, tested code libraries, and validated patterns. This coordination reduces commissioning delays, minimizes rework, and supports predictable multi‑site scale‑out.
Agility Built into the Digital Backbone
Rockwell Automation equips organizations with the tools to adapt to new modalities, regulatory shifts, and changing market demands through digital twins, unified data threads, modern MES capabilities, and scalable automation platforms.
Some organizations are beginning to pair these capabilities with predictive simulation models that incorporate ML‑based scenario evaluation to strengthen risk assessment and operational readiness.
Global Presence Backed by Local Expertise
With in‑region teams across the globe, Rockwell Automation provides responsive support, regulatory alignment, and modernization guidance—helping facilities maintain uptime and consistency across distributed networks.
A Commitment to Long-term Partnership
Commissioning isn’t the end—it’s the beginning. Rockwell Automation supports modernization, cybersecurity, workforce training, optimization, and expansion throughout the entire facility lifecycle.
Ready to Take the Next Step?
If this blog has sparked your curiosity and you want to explore the five strategic priorities in more detail, you can find a deeper explanation in our “Scaling Success in Life Sciences” eBook. The eBook expands on the concepts shared in this blog. It provides practical frameworks, proven customer outcomes, and guidance to help you accelerate delivery and strengthen your new capacity strategy.
