The Future of CGMP Facilities

In the evolving landscape of pharmaceutical manufacturing, the industry is reaching a point where strategic facility design must balance immediate market demands with long-term operational sustainability. Current market drivers are influenced by the twin requirements of cost and speed to market, though these needs are becoming increasingly nuanced depending on the specific drug type and company profile.

Peter Makowenskyj, senior director of Design Consulting at G-CON, and Beata Sweryda-Krawiec, associate director at Boehringer-Ingelheim, took a look at the decisions being made by pharmaceutical companies when it comes to current good manufacturing practice (cGMP) facility design during a Quick Fire discussion, “Drivers for Future cGMP Facilities” at INTERPHEX on Tuesday, April 21, 2026.1 The event is being held in New York City from April 21-23, 2026.

How Do Engineering and Procedural Controls Conflict?

Tension exists in modern pharmaceutical facility design between engineering-based controls and procedural-based controls.Often, projects facing budget constraints look to “value engineer” designs by reducing engineering controls—such as physical segregation techniques for material and personnel flow—in favor of instituting stricter procedural controls. However, this creates a significant trade-off, as it shifts the burden of criticality onto the quality team and increases long-term operating costs compared to robust upfront engineering.

What About Lifecycle Cost and Material Selection?

Makowenskyj and Sweryda-Krawiecemphasized that the industry is moving away from traditional construction methodologies that relied on readily available materials not originally designed for pharmaceutical use. Instead of selecting the cheapest materials, designers should prioritize cost-effective materials that offer the best performance over the entire lifecycle of the facility. Choosing inferior materials can lead to compounding maintenance costs and higher operational expenses over time.

Operational Efficiency and Capacity Utilization

Operating costs remain a concern, particularly the fixed costs associated with maintaining 24/7 environmental conditions, such as air cycle rates and temperatures. The industry has seen a trend, especially within the advanced therapy medicinal products and contract development and manufacturing organization sectors, where many new facilities were built with low utilization rates due to small product pipelines. Maintaining high utilization rates is essential for facility viability, as low utilization can lead to industry consolidation.

What Roles Do Digitalization, Robotics, and Artificial Intelligence Play?

The future of pharmaceutical facilities is linked to digitalization, which serves as the foundation for leveraging data effectively. Key technological shifts include:

• Automated filling lines and robotic systems are now handling everyday tasks, driving down the overall cost of facilities.
• AI adoption is increasing, with an uptake rate now surpassing 20%. AI is being used for predictive analytics to understand component failure rates, allowing companies to reduce expensive redundancy while avoiding shutdowns.
• Leveraging digital twins and cloud-based solutions allows facilities to “flex” their operations, such as decreasing air change rates when appropriate to reduce energy consumption while maintaining compliance.

Regulatory Harmonization and Agile Facilities

As these technologies advance, regulatory harmonization between global agencies remains a challenge. While many enabling technologies for agile and point-of-care manufacturing were discussed a decade ago, only now is the technology and regulatory support from agencies like the FDA catching up to make these independent, decentralized facilities a reality.

A Shift to Total Investment Value

The panel suggested the industry shift from focusing solely on CapEx to a focus on the total cost of investment over time. By putting more money into the upfront design and choosing the right technological integrations, companies can ensure their facilities operate with maximum efficiency and lower total costs throughout their functional lifespan.

Reference

1. Makowenskyj P, Sweryda-Krawiec B. Quick Fire: “Drivers for Future cGMP Facilities”. INTERPHEX. April 21, 2026. https://www.interphex.com/en-us/education/education-schedule/session-details.4766.258095.quick-fire-drivers-for-future-cgmp-facilities.html