Due to their ability to control contamination and maintain a sterile environment, cleanrooms are critical to the manufacturing of cell and gene therapies. They help to ensure the safety, purity, and efficacy of these complex therapies, along with adherence to strict regulations and standards.

As the global cell and gene therapy (CGT) sector is experiencing growth, to keep pace with the growing demand, many companies face complex and evolving operation challenges. While the challenges of scaling out CGTs are multi-faceted, we have designed modular cleanroom solutions to offer a chance to future-proof operations in cell and gene therapy production. 

Our solutions do not focus solely on the production capacity but look at the needs of related upstream processes that feed into manufacturing. We help our clients to plan their manufacturing for the long term and look at operational requirements that may arise during the next 5-10 years. Our modular structures can be deployed quickly to facilitate technology transfer, provide QC lab space, maintain specialized equipment, or provide warehouse space for GMP activity and related upstream manufacturing processes. 

Since our guiding principle is to make our clients fully satisfied with the final project outcome, we work directly with them to customize their cleanroom up to the strictest required specifications for both manufacturing and research. Fully regulated and controlled, our custom modular cleanrooms are the right solution for large-scale and long-term manufacturing needs or for expanding current operations.

The modularly created cleanroom design allows our clients to go from single rooms to a ballroom design, thus double their capacities to move on to commercial manufacturing. This significantly reduces barriers to the development and commercialization of cell and gene therapies and unlocks their huge potential to realize life-changing achievements. 

Cleanrooms are using high air-recirculation rates and energy-intensive processes, which makes them up to 100 times as costly to operate compared to commercial facilities. On top of this, they operate 24 hours a day, seven days a week, making their electricity demand to constantly contribute to peak utility system demand. 

Drawing on our extensive experience in energy use in cleanrooms which we have installed, we have successfully combined energy efficiency and functionality and performance of cleanrooms, embracing a holistic approach to designing energy efficiency into the requirements of cleanrooms. This way we provide our clients with a working environment that both meets Good Manufacturing Practice (GMP) requirements and helps them improve their energy efficiency. 

To minimize construction and operating costs, we are introducing energy optimization at the earliest phase of the cleanroom design process. We determine the initial and projected loads in cleanrooms – to minimize pressure drop in air and water-based subsystems, since this design parameter has unarguably the greatest impact on power requirements. For this purpose, we use lower-face-velocity air-handling units, low-pressure-drop filters and optimally designed ductwork and air paths, including open plenums. Other important aspects that we pay special attention to in our cleanroom designs are adjusting air-change rate, and maximizing exhaust-system efficiency, which are important targets in our efforts to save energy considering their continuous operation. 

However, simply following best practices is not enough. Design and right decision making which involves all stakeholders are important issues to be addressed. For this reason, we closely coordinate with our clients during the design process, to make sure we keep the team “on the same page”, and to clarify the rationale for key design decisions. Additionally, we incorporate a comprehensive quality-assurance process into the projects and ensure that all staff operating in the facility receive training that includes proper operation of energy-efficiency features.  

NAYA Life Sciences opens a new production facility in Izmir, Turkey, to serve the growing demand for prefabricated modular cleanroom solutions. This site has an advantageous geographical position, close to current and potential new customers. 

The 35.000 m2 facility produces all components for NAYA Modular Cleanrooms, employing over 100 experienced technical and administrative staff. It is fully automated with the latest equipment and technology. 

“The decision to create a new production facility for modular cleanrooms’ components was made in early 2021, following the increased use of modular cleanrooms by our clients. Turkey was chosen for a number of reasons: the presence of strong local partners and our previous experience of working in the country, the proximity to a number of our markets and also convenient logistics, considering we are rapidly developing and actively moving into new markets” – underlined Miroslav Tonovski, CEO at NAYA Life Sciences. 

The company plans to gradually increase capacity and increase the number of specialists working on site. 

The new facility is a hub for NAYA Modular Cleanrooms, serving customers directly in Europe, USA, and the Middle East. Splitting the production means that the company can easily meet the increased demand and serve its customers more efficiently.