By Christopher M. Ladd, AIA, NCARB | Vice President & COO
Leading pharmaceutical manufacturers are developing drugs at a rapid pace. To keep up with demand, companies are finding new ways to ramp up their cGMP production with efficiency, adaptability and flexibility in mind.

Current Good Manufacturing Practices (cGMP)
The Federal Drug Administration (FDA) carefully monitors drug manufacturers’ compliance with its current Good Manufacturing Practice (cGMP) regulations to assure the quality of drug products. These regulations contain minimum requirements for the methods, facilities and controls used in manufacturing, processing and packing of a drug product. Architects and designers working within the cGMP industry must familiarize themselves with these regulations to ensure reliable testing laboratories that help prevent contamination.
Market Outlook
As biotech companies with headquarters in leading cities like Boston and San Francisco scale up to commercial manufacturing volumes at an advanced rate, they’re struggling to find space within budget to develop the vast size of facilities required for cGMP production. Expensive housing, utility costs and a scarce workforce are pushing companies to look elsewhere, even for their headquarters as it’s desirable to keep the drug manufacturing, packaging, and distribution processes in close physical proximity to where the drugs are originally developed in their research and development labs.
Larger and cheaper real estate footprints such as Research Triangle Park (RTP) in North Carolina offer a convenient location to nearby accredited universities including Duke University, North Carolina State University and the University of North Carolina at Chapel Hill. With a talented workforce from specialized certification programs, direct access to transportation and affordable living costs, RTP may surpass Boston as a thriving life science market if these factors don’t improve.
Flexibility and Advanced Design
In the fast-paced world of pharmaceuticals, adaptability is key. cGMP facilities must accommodate changes in production processes, equipment and regulations without disrupting operations. Flexible, modular designs allow for easy reconfiguration and expansion, enabling facilities to scale up or down as needed without compromising quality or compliance. Advanced technology like smart sensors, real-time monitoring systems and digital control systems are becoming standard features, providing greater control and visibility throughout the manufacturing process.

Emphasis on Contamination Control
Maintaining a sterile environment is paramount in cGMP facilities to ensure product quality and patient safety. Designing facilities with advanced HVAC systems, cleanroom technology and rigorous sanitation protocols helps minimize the risk of contamination from airborne particles, microbes and other sources. Barrier technologies, such as isolators and restricted access barrier systems (RABS), are also being increasingly integrated to prevent cross-contamination between different processing areas.
Collaboration and Integration of Spaces
Cross-functional collaboration is essential in cGMP facilities, where various departments and disciplines must work together seamlessly. Designing facilities with integrated workspaces, shared amenities and collaborative zones fosters communication, creativity and teamwork among employees. Open floor plans, modular furniture and multipurpose areas promote flexibility and adaptability, allowing teams to collaborate effectively across different stages of the manufacturing process. Ci worked with a medical device manufacturer to design their headquarters, integrating open/closed collaboration spaces with AV equipment to accommodate town halls, lectures and presentations that promote their mission internally to staff and foster social interaction.

As the pharmaceutical and biotech industries continue to evolve, so will the design of cGMP facilities. By embracing the future, Ci’s Science & Technology Practice creates environments that not only meet regulatory requirements but also foster innovation, efficiency, and safety. Ci’s in-house Lab & Manufacturing Planning team is committed to staying at the forefront of these forward-thinking design strategies to help our clients build the future of pharmaceutical manufacturing.